Oral rinses, mouthwashes and sprays for improving recovery following tonsillectomy

  • Review
  • Intervention

Authors


Abstract

Background

This is an update of a Cochrane review first published in The Cochrane Library in Issue 1, 2010 and previously updated in 2011.

Tonsillectomy is the surgical removal of lymphoid tissue, the palatine tonsil, which is located at the back of the throat. It is still commonly performed for patients who have recurrent bouts of acute tonsillitis. Although tonsillectomy is considered a fairly minor procedure, pain and bleeding are two of the most common complications; either may delay recovery and can on occasion lead to hospital readmission. Postoperative tonsillectomy medication should provide an adequate reduction in morbidity while minimising side effects, therefore topical agents would seem to be an ideal, safe option. A number of mouthwashes and topical sprays are available which offer pain relief or can help to reduce bleeding in the immediate postoperative period.

Objectives

To assess the effects of oral rinses, mouthwashes and sprays in improving recovery following tonsillectomy.

Search methods

We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL); PubMed; EMBASE; CINAHL; Web of Science; Cambridge Scientific Abstracts; ICTRP and additional sources for published and unpublished trials. The date of the most recent search was 4 July 2013.

Selection criteria

We included randomised controlled trials in which oral rinses, mouthwashes and sprays, used pre- and postoperatively, have been compared with placebo in adults or children undergoing tonsillectomy, with or without adenoidectomy.

Data collection and analysis

Two review authors selected trials for inclusion, assessed the risk of bias and extracted data independently.

Main results

We included seven trials (593 participants; 397 children and 196 adults). The period of follow-up ranged from 24 hours to two weeks. Few of the trials provided reliable data for the pre-specified primary outcomes and none for the secondary outcomes. The risk of bias was high in most of the included trials. Lidocaine spray appeared to be more effective than saline spray at reducing the severity of pain until the third postoperative day. A small number of participants experienced a burning or stinging sensation with benzydamine spray but not sufficient to discontinue usage.

Authors' conclusions

Poor reporting quality and inadequate data did not permit comprehensive and reliable conclusions to be made. Future trials should be well-constructed and pay more attention to the methods used to assess outcomes, the timing of the assessments, and the quality of reporting and subsequent analysis of the data.

Plain language summary

Oral rinses, mouthwashes and sprays for improving outcomes following tonsillectomy

Tonsillectomy is one of the most common operations performed in adults and children. Pain and bleeding following the operation are common. Postoperative tonsillectomy medication should aim to minimise some of these symptoms. A number of mouthwashes and topical sprays are available which offer pain relief or can help to reduce bleeding in the period just after surgery.

This review included seven studies involving 593 participants (397 children and 196 adults) and is up to date as of July 2013. The risk of bias was high in most of the included trials. We found that lidocaine spray appeared to be more effective than a placebo saline spray at reducing the severity of pain until the third postoperative day. A small number of participants experienced a burning or stinging sensation when they used another spray containing benzydamine but this was not sufficient to discontinue its usage.

Further research should aim to provide reliable evidence for people to make informed decisions as to whether these treatments can be effective in reducing the most common symptoms and complications following tonsillectomy.

Summary of findings(Explanation)

Summary of findings for the main comparison. Oral rinses, mouthwashes and sprays to improve recovery after tonsillectomy
  1. 1The incompleteness of trial details, and in particular the lack of clarity about sequence generation and concealment, was a serious limitation in the included trial (Kaygusuz 2003). Subjective outcome assessment of pain coupled with potentially inadequate blinding leading to biased assessment of the intervention effect are likely to have further compromised the quality of the evidence.
    2The included trial met the eligibility criteria but addressed a restricted version of the review in terms of this outcome, in not providing data for the time to complete resolution of pain which is an important patient preferred outcome.

Oral rinses, mouthwashes and sprays to improve recovery after tonsillectomy
Patient or population: patients with tonsillectomy
Settings: hospital or ENT clinic
Intervention: lidocaine
OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of participants
(studies)
Quality of the evidence
(GRADE)
Comments
Assumed riskCorresponding risk
Control Lidocaine
Pain: severity score day 1
Scale from: 1 to 5
Follow-up: 7 days
The mean pain severity score on day 1 in the control groups was
4.3
The mean pain severity score on day 1 in the intervention groups was
2.0 lower
(2.79 to 1.21 lower)
 40
(1 study)
⊕⊕⊝⊝
low 1,2
 
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval
GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

Background

Description of the condition

This is an update of a Cochrane review first published in The Cochrane Library in Issue 1, 2010 and previously updated in 2011.

Tonsillectomy is the surgical removal of lymphoid tissue, the palatine tonsil, which is located at the back of the throat. Although a Cochrane review (Burton 2009) highlighted some uncertainty regarding the indications for tonsillectomy and its effectiveness in terms of the benefits and relative risks, it is still commonly performed for patients who have recurrent bouts of acute tonsillitis. The National Prospective Tonsillectomy Audit (NPTA) in the UK reported that 76% of patients who underwent tonsillectomy did so due to recurrent acute tonsillitis (Ramsden 2005). However, as a result of increased usage of antibiotics in the management of tonsillitis there has been a recent shift in the indications for tonsillectomy in paediatric patients, from the treatment of infection (recurrent acute tonsillitis) to the treatment of airway obstruction (obstructive sleep apnoea) (Lim 2001), although chronic infection remains the most common indication for adult tonsillectomy (Hoddeson 2008).

A range of surgical techniques continue to be used; these include 'cold' cutting, dissection and snaring, electrocautery, laser tonsil ablation (LTA), harmonic (ultrasonic) scalpel (Burton 2004), monopolar radiofrequency ablation, bipolar radiofrequency ablation (coblation) (Burton 2007), thermal welding and micro-debriding.

Despite the fact that tonsillectomy is considered a fairly minor procedure, it is often associated with significant postoperative morbidity including pain, bleeding, difficulty in swallowing, earache, fever, mouth odour, weight loss and reduced oral intake (Mann 1999). Pain and bleeding are two of the most common complications; either may delay recovery and can lead to hospital readmission (Chacra 2005; Lee 1996; Schloss 1994).

Postoperative pain, ranging from mild to severe, may last from a few days to two weeks and can affect oral intake, sleeping pattern and ultimately the quality of life (Chacra 2005). Severe pain has been reported in 20% to 50% of children and young adults who have undergone tonsillectomy (Canbay 2008; Kotiniemi 1997; Romsing 2000). A Cochrane systematic review found that there was no evidence that perioperative use of local anaesthetic injection and local anaesthetic spray could improve postoperative pain control (Hollis 1999).

Post-tonsillectomy primary or reactive bleeding rates (within the first 24 hours) can vary from 0.3% to 2.1%, whilst the rate of secondary bleeding requiring admission to hospital varies from 2% to 10% (Lee 2004; Ramsden 2005; Raut 2001; Walker 2007). Although neither a Cochrane review (Pinder 2011) nor a more recent literature review (Leinbach 2003) identified any difference in the rate of secondary haemorrhage after a range of surgical techniques, there have been reports more recently of lower bleeding rates after 'cold' tonsillectomy techniques when compared with 'hot' tonsillectomy techniques (Walker 2007).

Description of the intervention

The ideal postoperative tonsillectomy medication should provide an adequate reduction in morbidity while minimising side effects, therefore topical agents would seem to be an ideal, safe option. There are a number of mouthwashes and topical sprays available which offer pain relief or may be able to help reduce postoperative bleeding.

How the intervention might work

Surgical tissue damage is responsible for a substantial proportion of the pain and bleeding following tonsillectomy. Some mouthwashes have a direct mode of action by either anaesthetising the area, providing topical pain relief (analgesic effect) (e.g. lidocaine hydrochloride aerosol (Grainger 2008)) or both.

It is also suggested that post-tonsillectomy morbidity may in part be due to an increase in the colonisation of bacteria on the tonsillar bed and its subsequent inflammation. Therefore oral rinses which are capable of decreasing this microbiological colonisation and inflammation (e.g. hydrogen peroxide, topical antibiotics and corticosteroids) could also be indirectly effective in controlling postoperative pain (Chacra 2005) and bleeding (Pai 2005).

Why it is important to do this review

A number of topical agents, oral rinses and mouthwashes have been used in the management of acute post-tonsillectomy pain and bleeding. Some of these agents (e.g. hydrogen peroxide (H2O2) mouth rinses) have been used for many years. Interventions to improve recovery following tonsillectomy have been evaluated in a number of studies, but to the best of our knowledge there has not been a systematic review of the evidence for the effectiveness of oral rinses, mouthwashes and sprays.

Objectives

To assess the effects of oral rinses, mouthwashes and sprays for improving recovery following tonsillectomy.

Methods

Criteria for considering studies for this review

Types of studies

Randomised controlled trials (RCTs).

Types of participants

Adults and children without significant comorbidity (e.g. diabetes, chronic lung disease, bleeding disorders), who underwent tonsillectomy, with or without adenoidectomy, by any of the recognised surgical techniques.

Types of interventions

We considered studies in which oral rinses, mouthwashes and sprays, used pre- and postoperatively, have been compared with placebo for the outcomes sought in this review.

  1. Oral rinses and mouthwashes used as a rinse or gargle preoperatively and postoperatively.

  2. Spraying of any topically acting agent onto the surgical site postoperatively.

We excluded 'swish and swallow' agents with potential systemic effects which might confound assessment of the primary outcomes sought for this review. Concomitant administration of any other form of pain medication which may influence any of the outcomes was acceptable providing it was available equally to both the treatment and control group.

Types of outcome measures

We included any of the following outcomes, evaluated at the time of discharge, during the first 48 hours and at any time points in follow-up for a period of two months postoperatively.

Primary outcomes
  1. Pain: reduction in severity.

  2. Pain: time to complete resolution.

  3. Pain medication: postoperative pain medication type, dosage and reduction in the demand postoperatively.

  4. Bleeding: time to complete cessation.

  5. Bleeding: postoperative measures to reduce bleeding.

Secondary outcomes
  1. Readmission for any reason.

  2. Duration of hospital stay.

  3. Time to return to normal diet and activities.

Adverse outcomes

We reported on any specific adverse effects, systemic or local toxicity, any clinically diagnosed hypersensitivity or other unacceptable or adverse events associated with any of these treatments.

Search methods for identification of studies

We conducted systematic searches for randomised controlled trials. There were no language, publication year or publication status restrictions. We were unsuccessful in obtaining clarification of trial details from trial investigators but managed to arrange translations of papers not in the English language. The date of the last search was 4 July 2013, following previous searches in 2011 and 2009.

Electronic searches

We searched the following databases from their inception: the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library 2013, Issue 6); PubMed; EMBASE; CINAHL; LILACS; KoreaMed; IndMed; PakMediNet; CAB Abstracts; Web of Science; ICTRP; Clinicaltrials.gov; ISRCTN; Google Scholar and Google. In searches prior to 2013, we also searched BIOSIS Previews 1926 to 2011.

We modelled subject strategies for databases on the search strategy designed for CENTRAL. Where appropriate, we combined subject strategies with adaptations of the highly sensitive search strategy designed by The Cochrane Collaboration for identifying randomised controlled trials and controlled clinical trials (as described in theCochrane Handbook for Systematic Reviews of Interventions Version 5.1.0, Box 6.4.b. (Higgins 2011). Search strategies for major databases including CENTRAL are provided in Appendix 1.

Searching other resources

We scanned reference lists of identified publications for additional trials and made attempts to contact trial investigators by e-mail to ask for details of additional published and unpublished trials. We searched PubMed, TRIPdatabase, Google and DynaMed to retrieve existing systematic reviews possibly relevant to this review, and scanned their reference lists for additional trials.

Data collection and analysis

Selection of studies

For this update four review authors (Zbys Fedorowicz (ZF), Esther van Zuuren (EVZ), Mona Nasser (MN) and Jassim H Al Langawi (JHL) independently assessed the abstracts of studies resulting from the searches. We obtained full copies of all relevant and potentially relevant studies, those appearing to meet the inclusion criteria, and those for which there were insufficient data in the title and abstract to make a clear decision. Zbys Fedorowicz (ZF) and Esther van Zuuren (EVZ) independently assessed the full-text papers and resolved any disagreement on the eligibility of retrieved studies through discussion and consensus, or through a third party (Mona Nasser (MN)). We excluded all irrelevant records and noted details of the studies and the reasons for their exclusion in the Characteristics of excluded studies table in RevMan 5.2 (RevMan 2012).

Data extraction and management

We entered study details into the Characteristics of included studies table in RevMan 5.2. The review authors collected outcomes data using a pre-determined form designed for this purpose.

In the previous updates two review authors entered extracted data into RevMan 5.2 and only included data if there was an independently reached consensus. Any disagreements were resolved by consulting with a third review author.

We extracted the following details.

  1. Trial methods: (a) method of allocation, (b) masking of participants, trialists and outcomes assessors, (c) exclusion of participants after randomisation and proportion and reasons for losses at follow-up.

  2. Participants: (a) country of origin and location: private clinic or academic institute, (b) sample size, (c) age, (d) sex, (e) inclusion and exclusion criteria.

  3. Intervention: (a) type, dosage, (b) length of time in follow-up.

  4. Control: (a) type, dosage, (b) length of time in follow-up.

  5. Outcomes: (a) primary and secondary outcomes mentioned in the Types of outcome measures section of this review.

If stated, we recorded the sources of funding of any of the included studies. We used this information to help us to assess heterogeneity and the external validity of the trials.

Assessment of risk of bias in included studies

Three review authors (ZF, EVZ and MN) assessed the risk of bias of the selected studies independently using The Cochrane Collaboration's tool for assessing risk of bias as described in Chapter 8, section 8.5, of the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). We compared the evaluations and discussed and resolved any disagreements between the review authors.

We assessed the following domains as 'low risk of bias', 'unclear' (uncertain risk of bias) or 'high risk of bias':

  1. sequence generation;

  2. allocation concealment;

  3. blinding (of participants, personnel and outcome assessors);

  4. incomplete outcome data;

  5. selective outcome reporting;

  6. other bias.

These assessments are reported for each individual study in the 'Risk of bias' tables (Characteristics of included studies).

Measures of treatment effect

Reduction in pain severity

Where this was reported as a discrete outcome, it had been measured with either a standardised visual analogue scale (VAS) (continuous data) or with a short categorical scale (ordinal data). We did not dichotomise these continuous data but calculated and presented the mean difference (MD) and 95% CI in pain severity between intervention and placebo groups.

We were unable to exercise the option to dichotomise the categorical outcomes data reported in the included studies because the ordinal data were only presented as mean daily scores and the reports did not provide sufficient independent data for further analysis. These data were not reported in this review.

Pain medication usage

Pain medication was reported as means per day for the treatment groups in one study.

Unit of analysis issues

Only studies with a parallel-group design were included, so participants had been randomised to either intervention or control with subsequent analysis at individual allocation level.

Dealing with missing data

We made attempts to retrieve missing data from some of the investigators in the included trials but in view of the age of some of these trials this proved unsuccessful.

Assessment of heterogeneity

In view of the lack of data that could be included in a meta-analysis we did not assess clinical heterogeneity, but in future updates or if further data are available we will apply the following methods of assessment:

We will assess clinical heterogeneity by examining the characteristics of studies, the similarity between types of participants and the interventions. We plan to report heterogeneity as important if it is substantial (I2 statistic value between 50% and 90%, Higgins 2011); if the I2 statistic is greater than 90%, a meta-analysis will not be carried out. However, if heterogeneity could be explained by clinical reasoning and a coherent argument could be made for combining the studies, we will enter these into a meta-analysis.

Assessment of reporting biases

The paucity of trials and lack of data reporting the effects of the interventions did not permit an assessment of publication bias. In future updates we will assess publication bias by following the recommendations on testing for funnel plot asymmetry as described in section 10.4.3.1 of the Cochrane Handbook for Systematic Reviews of Interventions 5.1.0 (Higgins 2011), and this will be explored in the Discussion if appropriate.

Data synthesis

We sought statistical advice from the Cochrane ENT Group. Two review authors (MN and ZF) analysed data which addressed the primary and secondary outcomes of this review and had been extracted from the included studies using RevMan 5.2 (RevMan 2012) and reported analyses as suggested in Chapter 9 of the Cochrane Handbook for Systematic Reviews of Interventions 5.1.0 (Higgins 2011).

We did not attempt to synthesise the extracted data but in future updates or if further data become available the following methods will apply.

For the synthesis and meta-analysis of any quantitative data we will use the fixed-effect and random-effects models as appropriate. If we establish that there is significant heterogeneity between the trials, we will use the random-effects model.

In the event that there are insufficient clinically homogeneous trials for any specific intervention or insufficient study data that can be pooled, we will present a narrative synthesis.

Subgroup analysis and investigation of heterogeneity

Lack of data did not permit a subgroup analysis but in future updates and if further data become available the following methods will apply.

We will conduct a subgroup analysis by splitting and categorising the data based on the type of mouth rinse, its method of action and its use either pre- and/or postoperatively. We will also compare and analyse relevant outcomes data in which differing tonsillectomy procedures have been utilised in any of the included trials. We will explore the effects of confounding in the assessment of postoperative pain in studies where participants have undergone tonsillectomy alone or combined with adenoidectomy if an appropriate number of trials are found.

Sensitivity analysis

The limited amount of data extracted from the included studies did not permit a sensitivity analysis. For future updates and if there are sufficient included studies we plan to conduct sensitivity analyses to assess the robustness of our review results by repeating the analysis with the following adjustments: exclusion of studies with unclear or inadequate allocation concealment, unclear or inadequate blinding of outcomes assessment and unclear or inadequate completeness of follow-up.

Results

Description of studies

See: Characteristics of included studies and Characteristics of excluded studies.

Results of the search

The initial search in 2009 retrieved 70 references to studies. After examination of the titles and abstracts of these references, all but 27 studies were eliminated and excluded from further evaluation. We obtained full-text copies of the remaining studies, four of which required translation (Giacomelli 1984; Rustamov 1978; Schlorhaufer 1965; Schmidtmayer 1981). The review authors discussed the eligibility of these remaining studies, resolved any uncertainties by consensus and finally excluded all but six studies, which met our inclusion criteria.

The searches were re-run on 22 April 2011 and retrieved eight references to studies, none of which were eligible for inclusion in this review.

The latest search was conducted on 4 July 2013 and provided an additional 42 references to studies. After examination of the titles and abstracts all but seven were excluded. We obtained the full text of two reports and accessed the protocols to five ongoing studies; we subjected these to further evaluation. No further eligible studies other than one ongoing study were identified for inclusion (see Characteristics of ongoing studies). One previously excluded study (Schmidtmayer 1981) was reassessed and included in the review.

For further details of the search history see Figure 1.

Figure 1.

Study flow diagram.

Included studies

Seven studies, all of which were randomised, double-blinded, placebo-controlled trials, were included in this review (Abou Chacra 2005; Giacomelli 1984; Kaygusuz 2003; Raj 1986; Schmidtmayer 1981; Valijan 1989; Young 1987).

None of the included studies comprehensively addressed the primary and secondary outcomes specified in the protocol for this review and they only provided a limited amount of reliable data. However, we considered that the inclusion of these studies and the reporting of their results would help provide at least some evidence towards answering this research question.

Characteristics of the trial setting and investigators

The trials were conducted in the ENT departments of university or general hospitals in Turkey (Kaygusuz 2003), the UK (Raj 1986; Valijan 1989; Young 1987), Canada (Abou Chacra 2005), Germany (Schmidtmayer 1981) and Italy (Giacomelli 1984). They took place over different time periods ranging from 24 hours to up to two weeks (Abou Chacra 2005) postoperatively.

The providers of treatment in the trials were university and hospital research staff and the assessors of outcomes included the healthcare providers, ancillary staff, the participants and their carers.

Characteristics of the participants

The total sample size comprised 593 participants (397 children, 196 adults). Gender was incompletely reported in several of the studies. Two separate age groups, adults (14 to 62 years) and children (four to eight years), were studied in Raj 1986, only adults participated in Schmidtmayer 1981 and Valijan 1989, and the participants in the four remaining studies consisted of children and adolescents. Participants in all of the included studies had been previously admitted for elective tonsillectomy with or without adenoidectomy and were generally discharged either the same day or within 48 hours.

Interventions

In all of the trials, with the exception of Abou Chacra 2005 in which participants used mouth rinses and in Schmidtmayer 1981 gargles, the interventions were delivered by sprays (Giacomelli 1984; Kaygusuz 2003; Raj 1986; Valijan 1989; Young 1987).

Benzydamine hydrochloride was the most frequently used intervention (Giacomelli 1984; Raj 1986; Schmidtmayer 1981; Valijan 1989; Young 1987), whilst lidocaine was used in Kaygusuz 2003 and hydrogen peroxide in Abou Chacra 2005.

These interventions were compared with normal saline spray (Kaygusuz 2003), water (Abou Chacra 2005; Valijan 1989) and an unspecified placebo (Giacomelli 1984; Raj 1986; Schmidtmayer 1981; Young 1987).

The exact timing and duration of administration of the interventions varied markedly between the studies. In Abou Chacra 2005, Giacomelli 1984, Kaygusuz 2003, Schmidtmayer 1981, Valijan 1989 and Young 1987 participants received the interventions at varying times postoperatively. In Raj 1986 they were delivered once intra-operatively and for an unspecified time postoperatively. In those studies in which the intervention was administered after the immediate postoperative period it was either self administered, by a nurse or by the participant's parent or carer.

Outcomes

The severity of postoperative pain, which was one of the primary outcomes of this review, was assessed in all of the studies with the exception of Schmidtmayer 1981, but there was wide variability between the studies in terms of the methods used, the timing of the assessments, the assessors of these outcomes and the quality of reporting and subsequent analysis of the data.

These outcomes were assessed with a standardised visual analogue scale (VAS) in Abou Chacra 2005, Kaygusuz 2003 and Valijan 1989, and by ordinal rating scales in Giacomelli 1984, Raj 1986 and Young 1987. They were self assessed in Kaygusuz 2003 and Valijan 1989, and investigator-assessed in Young 1987. In the remaining studies, with the exception of Giacomelli 1984 in which it was unclear who the assessors were, the assessments were made by the investigators, carers and participants.

In two of the studies (Valijan 1989; Young 1987) the methods used to assess outcomes and the corresponding data were inadequately reported.

The only study that addressed the use of postoperative pain medication, dosage and reduction in demand postoperatively was Schmidtmayer 1981.

The daily pain scores in one study (Giacomelli 1984) were collected from a short (four-point) categorical symptom scale, and were transformed into mean daily scores. However, the averaging of ordinal data obtained from the narrow range of possible answers on this type of scale into means and mean change scores is generally considered incapable of providing a value that is readily interpretable or particularly useful.

In several of the studies the pain ratings were not reported separately but the data were consolidated into composite global symptom scores.

The rather limited data in Raj 1986 were only reported as global symptom scores which included ratings for sore throat, dysphagia and earache.

The investigators in Kaygusuz 2003 reported that a VAS was used to assess severity of pain "caused by drinking 100 ml of water" but the report was unclear if this stimulus was applied at any of the assessment times other than the immediate postoperative period (< 24 hours).

Although none of the included studies reported any appreciable data related to postoperative bleeding, all of the included studies, other than Giacomelli 1984, Kaygusuz 2003 and Young 1987, reported some data on analgesic usage, but most of these data were not suitable for further analysis.

None of the secondary outcomes specified in the protocol for this review were addressed by the included studies. Ultimately the outcome assessments reported in the included studies provided a limited amount of useful data.

Further details are available in the Characteristics of included studies table.

Excluded studies

All of the studies which were excluded from this review and the reasons for their exclusion are listed in the Characteristics of excluded studies table.

Risk of bias in included studies

We categorised risk of bias in the included studies according to the following:

  1. low risk of bias (plausible bias unlikely to seriously alter the results) if all criteria were met;

  2. moderate risk of bias (plausible bias that raises some doubt about the results) if one or more criteria were partly met; or

  3. high risk of bias (plausible bias that seriously weakens confidence in the results) if one or more criteria were not met.

We classified the majority of the included studies as 'high risk of bias', an assessment which was to a certain extent based on the inadequate reporting of the criteria that are a prerequisite in the evaluation of methodological rigour in terms of trial design and conduct. Concealment of the allocation sequence and blinding are key domains in the assessment of risk of bias and more especially where studies include subjective outcomes assessments.

For further details see the 'Risk of bias' graph (Figure 2) and 'Risk of bias' summary (Figure 3).

Figure 2.

'Risk of bias' graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.

Figure 3.

'Risk of bias' summary: review authors' judgements about each methodological quality item for each included study.

Allocation

Randomisation

The method of randomisation was not clearly reported in any of the studies and therefore we judged this domain as 'unclear' for all of these studies.

Allocation concealment

Inadequate reporting quality, emphasised by a degree of uncertainty as to whether adequate measures had been taken to ensure that the investigators were unaware of the upcoming assignment, did not permit a clear judgement of the risk of bias for this domain in all of the included studies, other than Abou Chacra 2005 which we judged as high risk of bias.

Blinding

Unfortunately the inconsistent and less than satisfactory quality of reporting did not enable clear, accurate and complete judgements to be made for the adequacy of blinding of the healthcare providers, participants or assessors of the outcomes in most of the included studies.

The investigators in one study (Abou Chacra 2005) indicated that although the solutions were in identical bottles the participants were able to recognise the difference in taste between the intervention and control.

The reportedly "identical characteristics" of the preparations used in Giacomelli 1984 would appear to confirm that the participants were effectively blinded but the report was unclear as to how the investigators were blinded to the interventions allocated to the participants.

In Kaygusuz 2003 the interventions were initially administered intraoperatively and although the blinding of the participants appears to have been effective for this time period the report was unclear how blinding was further ensured in the postoperative administration period. This report also did not describe how the investigators were blinded to the assigned interventions.

Effective blinding of both the participants and investigators in Raj 1986 and Valijan 1989 was achieved by the use of a placebo and active preparation which were similar in taste, smell and colour.

Although the investigators in Schmidtmayer 1981 and Young 1987 stated that their study was double-blind, it was not possible to make a clear judgement about this domain based on the information presented in the report.

The satisfactory and effective blinding of outcome assessors in Abou Chacra 2005, Giacomelli 1984, Kaygusuz 2003, Schmidtmayer 1981 and Young 1987 could not be confirmed from the study details presented in these reports.

Incomplete outcome data

There was no evidence of incomplete reporting of outcome data in two of the studies (Raj 1986; Schmidtmayer 1981) but in Giacomelli 1984, Kaygusuz 2003, Valijan 1989 and Young 1987 it was 'unclear'. There were substantial losses to follow-up in Abou Chacra 2005; the outcome data were incompletely reported and losses were inadequately addressed and therefore we judged this domain as high risk of bias in this study.

Selective reporting

Although the study protocols were not available for any of the studies, five of them (Abou Chacra 2005; Kaygusuz 2003; Raj 1986; Schmidtmayer 1981; Young 1987), based on information available in the respective methods sections, reported on all of the stated objectives and expected outcomes. The report in Giacomelli 1984 was unclear and it was not possible to make a definitive judgement about this item in this review. We also judged the remaining studies as not entirely free of selective reporting for the reasons described in the corresponding 'Risk of bias' table for each study (Characteristics of included studies).

Other potential sources of bias

Whilst it was unclear if the pharmaceutical company sponsorship of three trials (Raj 1986; Valijan 1989; Young 1987) could be deemed a potential source of bias, other potential sources of bias were identified in Abou Chacra 2005 and Schmidtmayer 1981 (see 'Risk of bias' tables).

We considered the two remaining studies (Giacomelli 1984; Kaygusuz 2003) to be free of other potential sources of bias.

Effects of interventions

See: Summary of findings for the main comparison Oral rinses, mouthwashes and sprays to improve recovery after tonsillectomy

Due to clinical diversity between the studies in terms of their interventions, the methodological diversity in study design and the overall inadequate standard of reporting of data, it was not possible to synthesise the data and a narrative synthesis is presented.

Pain: reduction in severity, time to complete resolution, analgesic usage

Only one of the included trials provided some reliable data on the reduction of pain severity (Kaygusuz 2003). In this study lidocaine spray appeared to be more effective than NaCl (saline) spray at reducing pain, but the effect was rather limited and lasted only until the third day post-tonsillectomy (see Analysis 1.1; Analysis 1.2; Analysis 1.3; Figure 4; Figure 5; Figure 6).

Figure 4.

Forest plot of comparison: 1 Pain severity, outcome: 1.1 Day 1.

Figure 5.

Forest plot of comparison: 1 Pain severity, outcome: 1.2 Day 3.

Figure 6.

Forest plot of comparison: 1 Pain severity, outcome: 1.3 Day 7.

Contradictory conclusions reached by the investigators in Giacomelli 1984 and Raj 1986 in terms of the effectiveness of pain relief with benzydamine, and the lack of its effectiveness in Valijan 1989 and Young 1987, could not be supported by the data presented by the investigators in any of these trials.

The mean number of tablets per day (lozenges of acetylsalicylic acid) over seven days was 14.2 in the intervention group versus 19.0 in the placebo group (Schmidtmayer 1981).

The paucity of data and the implausible analysis in Abou Chacra 2005 did not permit reliable conclusions to be reached about postoperative analgesic usage in this trial and therefore the data have not been included in this review. None of the other included trials provided any data for analgesic usage.

Bleeding: time to complete cessation, postoperative measures to reduce bleeding

Only one trial (Abou Chacra 2005) reported on this outcome but provided limited data. Bleeding was reported on the sixth postoperative day and occurred only in the group that received hydrogen peroxide. However, the measures, if any, that were used to reduce the bleeding were unstated.

Readmission for any reason, duration of hospital stay

No data were available.

Time to return to normal diet and activities

None of the studies reported data on these outcomes.

Adverse outcomes

A small number of participants experienced a burning sensation with benzydamine in Raj 1986 and a stinging sensation in Valijan 1989, but it was stated that this was not sufficient for them to discontinue usage. No other adverse effects were reported in the remaining trials.

Discussion

Summary of main results

Our comprehensive search for randomised controlled trials which examined the effects of the interventions specified in the protocol for this review retrieved a number of trials in which the investigators appeared to be supportive of the effectiveness of several interventions, but provided very limited and poor-quality data to substantiate these claims. We were unable to obtain adequate data from most of the trials and we summarise only the results from our analysis of two of the outcomes from two of the trials.

Pain severity when lidocaine was used as a topical spray was markedly less (P < 0.05) when compared with 9% NaCl (saline) spray in the immediate and up to three days post-tonsillectomy period, but the results in both groups were not dissimilar by the seventh day (Kaygusuz 2003).

Overall completeness and applicability of evidence

It was quite striking to see how few of the included trials, a number of which date back 20 years, although apparently addressing post-tonsillectomy morbidity, have provided such limited and incomplete evidence for the effect of sprays and mouthwashes in improving postoperative outcomes for such a common surgical procedure.

Conceivably the use of more potent and possibly longer-acting systemic rather than topical analgesics might be considered more appropriate for pain relief and in particular if their use might obviate the necessity of repetitive and possibly painful spraying of a raw surgical area, notwithstanding the attendant problems of compliance, particularly in the child or younger patient.

Whilst the applicability of evidence of the benefits of topically acting agents such as lidocaine in providing some measure of analgesia is perhaps not in question, this may not be the case with the rather limited, if any, topical analgesic properties of either benzydamine or hydrogen peroxide. However, the applicability of the perceived benefits of lidocaine may need to be offset by the possible inconvenience of having to spray the surgical site several times a day for a number of days.

Pain is not the only post-tonsillectomy sequela and, although the complexities involved in assessing pain are acknowledged, the evaluation of the recognised anti-inflammatory properties of benzydamine and in particular its effects on accelerating the healing process would have been a valuable contribution to the overall completeness of the evidence base.

Quality of the evidence

We were unable to provide a 'Summary of findings' (SoF) table to assess the quality of evidence across all the studies and therefore provide a descriptive summary of the assessment for only one primary outcome from a single study (Kaygusuz 2003) from which the relevant data were available.

Pain: reduction in severity, time to complete resolution

Limitations in study design

The lack of clarity in sequence generation and its concealment, in addition to inadequate blinding coupled with potentially biased assessment of the effects of the intervention, are likely to have compromised the quality of the evidence.

Unexplained heterogeneity and inconsistency of results

As only one trial was included in Summary of findings for the main comparison this assessment was not applicable.

Indirectness of evidence (indirect population, intervention or control, outcomes)

Although the included trial met the eligibility criteria for inclusion it only addressed a restricted version of the review in terms of this outcome, in not providing any data for the time to complete resolution of pain which is an important patient preferred outcome for this review question.

Imprecision of results

The limited amount of outcome data available from this single trial did not permit any assessment of the precision of the results.

High probability of publication bias

In view of the low number of trials included in this review this assessment was not estimable.

For further details see Summary of findings for the main comparison.

Potential biases in the review process

We made strident attempts to limit bias in the review process by ensuring a comprehensive search for potentially eligible studies, which included searching in other than the major databases and which resulted in the retrieval of a number of studies from journals that are not indexed to those major databases. The effects of language bias on the identification and selection of studies is widely recognised and therefore we ensured that all studies that were not in the English language were translated by native language speakers and that this extended to assistance with the assessment of study eligibility and risk of bias. However, we accept that the incompleteness of some of the reports and our inability to obtain clarification of certain trial details or to resolve ambiguities in the reports may have contributed to some bias in their assessment, but where these conditions applied this was explicitly stated in the text of our review.

Agreements and disagreements with other studies or reviews

We are not aware of any other reviews that have considered this research question. DynaMed, which systematically monitors research for clinical practice and is updated daily, did not have additional evidence beyond the evidence summarised in our review (DynaMed 2013).

Authors' conclusions

Implications for practice

Whilst it is likely that no single intervention is capable of alleviating all of the postoperative morbidities associated with tonsillectomy, it is possible that interventions are available which might prove to be effective for pain relief, whilst others, such as the anti-inflammatories, may reduce swelling and others may be beneficial in preventing postoperative bleeding.

The use of topical analgesic agents has been previously advocated, but whilst they may be considered to have the potential to reduce the severity of pain, it is uncertain from this review to what extent they are effective and whether the use of concomitant systemic pain medication may contribute to enhancing these effects or is indeed capable of providing more effective pain relief.

The lack of agreement over the evidence for the effectiveness of benzydamine spray, which was illustrated by the discordant results from several trials, did not permit any reliable conclusions to be reached about its continued use.

Whilst the limitations of repetitive spraying of a surgical site with any of these medications, particularly in children, are recognised, the evidence in support of either continuing or discontinuing these interventions remains unclear.

Implications for research

Severity of pain and its control is likely to be the most significant patient preferred outcome following tonsillectomy. The ability to measure pain intensity, pain duration and the effect of analgesics accurately is an important task in both clinical practice and research and was one of the challenges faced, perhaps unknowingly, by the investigators in several of the included trials. It is well recognised that the interpretations of pain severity, intensity or both can be complex, may vary for a variety of reasons and be fundamentally dependent on whether the evaluation is investigator, self or carer assessed. For this reason the measures used to assess pain should be valid, reliable and be able to provide consistently trustworthy pain ratings irrespective of who is administering the test. However, some of these measures, a number of which were used in the included trials, of necessity include physical parameters (crying, respiration rate, facial expression) which provide indirect estimates of pain and may be viewed as potential confounders in the assessment of pain. Although a range of standardised visual analogue scales (VAS) are available, many with excellent psychometric properties and which are flexible enough for use in any setting, colour-coded rating scales with verbal descriptors may prove more useful for children.

The choice of any intervention to be investigated must reflect a rational explanation of its effect and should also address relevant and appropriate outcomes, thus interventions which do not have any recognised analgesic properties are unlikely to provide useful data for reduction in severity of pain.

Investigators in future trials might also consider using multiple arms with different dosages and regimens against placebo, preferably with clearly stated time points of outcome assessments, and that these trials should be well designed and reported according to the Consolidated Standards of Reporting Trials (CONSORT) statement (http://www.consort-statement.org).

For further research recommendations based on the EPICOT format (Brown 2006) please see Table 1.

Table 1. Research recommendations based on a gap in the evidence on oral rinses, mouthwashes and sprays for improving recovery following tonsillectomy 
  1. RCT: randomised controlled trial; VAS: visual analogue scale

Core elementsIssues to considerStatus of research for this review
Evidence
(E)
What is the current state of evidence?A systematic review identified several RCTs which matched the eligibility criteria, but most of which were inadequately reported and assessed as having 'high' to 'unclear' risk of bias
Population
(P)
Diagnosis, disease stage, comorbidity, risk factor, sex, age, ethnic group, specific inclusion or exclusion criteria, clinical settingPatients of any age, gender or ethnic group, without significant comorbidity (e.g. diabetes, chronic lung disease, bleeding disorders), who underwent tonsillectomy, with or without adenoidectomy, by any of the recognised surgical techniques
Intervention
(I)
Type, frequency, dose, duration, prognostic
factor

Spray, mouthrinse or instilled solution (in different dose, frequency or duration). Compliance to be recorded including any concomitant/rescue medications via pill counts

Based on current evidence some of these interventions, in particular lidocaine, have the potential to be effective and this should be further explored in future trials

Comparison
(C)
Type, frequency, dose, duration, prognostic factorPlacebo with a dose, frequency, duration comparable to the intervention. Compliance to be recorded, including any concomitant/rescue medications via pill counts
Outcome
(O)
Which clinical or patient-related outcomes will the researcher need to measure, improve, influence or accomplish?
Which methods of measurement should be used?

Pain severity: validated pain scale capable of measuring the multidimensional aspects of pain (sensory dimensions: location, quality, intensity, duration, frequency)

VAS: self assessed or carer-assessed (trained raters)
Calibrated face or colour-coded scales for children
Rescue medication: type, dosage and duration

Data: continuous and dichotomous

Time stamp
(T)
Date of literature search or recommendationJuly 2013
Study typeWhat is the most appropriate study design to address the proposed question?

Randomised controlled trial (adequately powered/large sample size)

Methods: concealment of allocation sequence

Blinding: patients, therapist, trialists, outcomes assessors, data analysts

Setting: inpatient or outpatient care with follow-up (< 7 days)

Acknowledgements

The review authors would like to acknowledge the assistance they have received from members of the Cochrane ENT Group and the helpful comments from the peer referees in developing the protocol and conducting this review. We are grateful to Dr Maqbool Jafary, Consultant Physician and Cardiologist of the Karachi Institute of Heart Diseases, Karachi Pakistan who obtained several of the full-text papers which were identified in our searches. We would like to thank Dr Bruce Manzer, Dr V Vlassov, Prof Vinicius Pedrazzi and Prof Ming Ming Zhang, who very kindly arranged to translate and provide invaluable assistance in assessing the eligibility of several non-English language papers. We also acknowledge the help we have received from Prof Marc W Heft of the Department of Oral & Maxillofacial Surgery at the University of Florida, Gainesville USA in obtaining a better understanding of the measurement of pain and the use of pain scales. The authors would like to acknowledge Nutayla Al-Harthy and Mohammed A Al-Muharraqi who contributed to earlier versions of this review.

Data and analyses

Download statistical data

Comparison 1. Lidocaine versus placebo
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Pain: change in severity. Day 1140Mean Difference (IV, Random, 95% CI)-2.0 [-2.79, -1.21]
2 Pain: change in severity. Day 3140Mean Difference (IV, Random, 95% CI)-1.2 [-1.98, -0.42]
3 Pain: change in severity. Day 7140Mean Difference (IV, Random, 95% CI)-0.40 [-0.93, 0.13]
Analysis 1.1.

Comparison 1 Lidocaine versus placebo, Outcome 1 Pain: change in severity. Day 1.

Analysis 1.2.

Comparison 1 Lidocaine versus placebo, Outcome 2 Pain: change in severity. Day 3.

Analysis 1.3.

Comparison 1 Lidocaine versus placebo, Outcome 3 Pain: change in severity. Day 7.

Appendices

Appendix 1. Search strategies

CENTRALEMBASE (Ovid)CINAHL (EBSCO)Cochrane ENT Disorders Group Trials Register (ProCite database)
#1 MeSH descriptor Tonsillectomy explode all trees
#2 (tonsillectom* OR tonsilectom* OR adenotonsillectom* OR adenotonsilectom* OR tonsillotom* OR tonsilotom*)
#3 MeSH descriptor Tonsillitis explode all trees
#4 MeSH descriptor Palatine Tonsil explode all trees
#5 (tonsil* OR adenotonsil*)
#6 (#3 OR #4 OR #5)
#7 MeSH descriptor Surgical Procedures, Operative explode all trees
#8 (surg* OR excis* OR extract* OR remov*)
#9 (#7 OR #8)
#10 (#6 AND #9)
#11 (#1 OR #2 OR #10)
#12 MeSH descriptor Mouthwashes explode all trees
#13 MeSH descriptor Administration, Topical explode all trees
#14 (rinse* OR rinsing OR mouthrins* OR mouthwash* OR wash* OR gargl* or spray* or topical*)
#15 (#12 OR #13 OR 14)
#16 (#11 AND #15)
1 exp Tonsillectomy/
2 (tonsillectom* or tonsilectom* or adenotonsillectom* or adenotonsilectom* or tonsillotom* or tonsilotom*).tw.
3 exp Tonsil/
4 exp Tonsillitis/
5 (tonsil* or adenotonsil*).tw.
6 exp Surgery/
7 (surg* or excis* or extract* or remov*).tw.
8 4 or 3 or 5
9 6 or 7
10 8 and 9
11 1 or 10 or 2
12 exp gargle/ or mouthwash/
13 topical drug administration/
14 (rinse* or rinsing or mouthrins* or mouthwash* or wash* or gargl* or spray* or topical*).tw.
15 13 or 12 or 14
16 11 and 15

S1 (MH "Tonsillectomy")

S2 TX tonsillectom* OR tonsilectom* OR adenotonsillectom* OR adenotonsilectom* OR tonsillotom* OR tonsilotom*

S3 (MH "Tonsil") or (MH "Tonsillitis+")

S4 TX tonsil* OR adenotonsil*

S5 (MH "Surgery, Operative")

S6 TX surg* OR excis* OR extract* OR remov*

S7 (S3 or S4) and (S5 or S6)

S8 S1 or S2 or S7

S9 (MH "Mouthwashes+")

S10 (MH "Administration, Topical+")

S11 TX rinse* OR rinsing OR mouthrins* OR mouthwash* OR wash* OR gargl* or spray* or topical*

S12 S9 OR S10 OR S11

S13 S8 AND S12

((tonsillectom* OR adenotonsillectom*) OR ((tonsil* OR adenotonsil*) AND (surg* OR excis* OR extract* OR remov*))) AND (rinse* OR rinsing OR mouthrins* OR mouthwash* OR wash* OR gargl* or spray* or topical*)
Web of Science (Web of Knowledge)CAB Abstracts (Ovid)PubMedICTRP
#1 TS=(tonsillectom* OR tonsilectom* OR adenotonsillectom* OR adenotonsilectom* OR tonsillotom* OR tonsilotom*)
#2 TS=((tonsil* OR adenotonsil*) AND (surg* OR excis* OR extract* OR remov*))
#3 TS=(rinse* OR rinsing OR mouthrins* OR mouthwash* OR wash* OR gargl* or spray* or topical*)
#4 #1 OR #2
#5 #3 AND #4
1 (tonsillectom* or tonsilectom* or adenotonsillectom* or adenotonsilectom* or tonsillotom* or tonsilotom*).tw.
2 exp Tonsillitis/
3 (tonsil* or adenotonsil*).tw.
4 exp Surgery/
5 (surg* or excis* or extract* or remov*).tw.
6 2 OR 3
7 4 OR 5
8 1 OR (6 AND 7)
9 (rinse* or rinsing or mouthrins* or mouthwash* or wash* or gargl* or spray* or topical*).tw.
10 8 AND 9
#1 "Tonsillectomy"[Mesh]
#2 "Palatine Tonsil/surgery"[Mesh]
#3 (tonsillectom* [tiab] OR tonsilectom* [tiab] OR adenotonsillectom* [tiab] OR adenotonsilectom* [tiab] OR tonsillotom* [tiab] OR tonsilotom*[tiab])
#4 #1 OR #2 OR #3
#5 "Tonsillitis" [Mesh]
#6 "Palatine Tonsil" [Mesh]
#7 (tonsil* [tiab] OR adenotonsil* [tiab])
#8 #5 OR #6 OR #7
#9 "Surgical Procedures, Operative"[Mesh]
#10 (surg* [tiab] OR excis* [tiab] OR extract* [tiab] OR remov* [tiab])
#11 #9 OR #10
#12 #8 AND #11
#13 #4 OR #12
#14 "Mouthwashes"[Mesh]
#15 "Mouthwashes"[Pharmacological Action]
#16 "Administration, Topical"[Mesh]
#17 (rinse* [tiab] OR rinsing [tiab] OR mouthrins* [tiab] OR mouthwash* [tiab] OR wash* [tiab] OR gargl* [tiab] or spray* [tiab] or topical* [tiab])
#18 #14 OR #15 OR #16 OR #17
#19 #13 AND #18
tonsil* AND topical* OR tonsil* AND rins* OR tonsil* AND mouthwash* OR tonsil* AND wash* OR tonsil* AND spray* OR tonsil* AND gargl*

What's new

Last assessed as up-to-date: 4 July 2013.

DateEventDescription
30 August 2013New citation required but conclusions have not changed

One previously excluded study (Schmidtmayer 1981) was reassessed and included.

One ongoing study met our inclusion criteria (based on the study protocol) and on completion will be added to future updates.

Change of authors.

4 July 2013New search has been performedNew searches run.

History

Protocol first published: Issue 2, 2009
Review first published: Issue 1, 2010

DateEventDescription
25 May 2011New search has been performedWe ran new full searches in April 2011, but identified no further studies which met our inclusion criteria.
25 May 2011New citation required but conclusions have not changedChange of authors.
27 October 2009AmendedTitle changed to include sprays and 'improving outcomes' changed to 'improving recovery'.

Contributions of authors

Zbys Fedorowicz (ZF), Esther J van Zuuren (EVZ), Mona Nasser (MN), Ben Carter (BC) and Jassim H. Al Langaw (JHL) were responsible for:

  • organising the retrieval of papers;

  • writing to authors of papers for additional information;

  • screening search results;

  • screening retrieved papers against inclusion criteria;

  • appraising the quality of papers;

  • data collection for the review;

  • extracting data from papers; and

  • obtaining and screening data on unpublished studies.

EVZ and ZF entered the data into RevMan.

ZF and EVZ was responsible for analysis and interpretation of the data.

ZF and MN were responsible for:

  • designing the review;

  • co-ordinating the review;

  • data management for the review.

All review authors contributed to writing the review.

EVZ and ZF are the guarantors for the review.

Declarations of interest

There are no financial conflicts of interest and the authors declare that they do not have any associations with any parties who may have vested interests in the results of this review.

Sources of support

Internal sources

  • None, Not specified.

External sources

  • None, Not specified.

Differences between protocol and review

The protocol for this review stated that if concomitant analgesics were required that they "be administered equally" to the treatment and control group; this has been changed to "be made available equally".

We excluded studies in which the intervention was delivered as a pack or a swab to the tonsillar fossa. 'Sprays' were added as interventions to be considered for this review.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Abou Chacra 2005

MethodsProspective, randomised, double-blinded clinical trial in Montreal Children's Hospital Canada (no date specified)
Participants

Demographic characteristics of patients at enrolment unreported

INCLUSION CRITERIA:

  • Specified as healthy children age 5 to 12 years undergoing elective outpatient tonsillectomy; concomitant procedures included adenoidectomy, myringotomy and insertion of middle ear ventilation tubes

EXCLUSION CRITERIA:

  • Pulmonary, cardiac, neurogenic, renal, digestive and haematologic diseases; severe sleep apnoea, coagulopathy, allergy to acetaminophen or codeine, and craniofacial or other syndromes

RANDOMISED: 101 enrolled; only 37 (18 male, 19 female) aged 5 to 12 years (average 7.5 years) completed the study and were analysed

WITHDRAWALS/TREATMENT FAILURES:

  • Drop-outs (64/101): reported as "incompliant, incomplete post-operative questionnaire or failed to return for follow-up"

Interventions

"Tonsillectomy by three surgeons using the same technique" (cautery knife); discharged same day

Intervention

  • Hydrogen peroxide mouth rinse diluted to 1% (21)

Comparator

  • Normal tap water (16)

No details reported about timing or frequency of interventions but continued usage from an "unlabelled bottle containing solution" after discharge

Outcomes

All outcome assessments were carried out at home, started day 1 postoperatively

  • Self assessed VAS Faces Pain Scale (Hicks 2001)

  • Questionnaire: level of pain (on swallowing, drinking and eating soft and 'ordinary' foods); quantity and timing of analgesic use. Recorded twice daily for 2 weeks

Notes

101 participants enrolled; sequence generation and allocation inadequate (selection bias), large number of drop-outs and incompleteness in data (attrition bias)

Data reported were largely unusable

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskQuote (page 179): "They were blindly randomized into two groups". "Randomization was achieved by an unlabelled bottle system"
Comment: the investigators appear to have confused sequence generation with blinding. Inadequate detail provided to make a clear judgement
Allocation concealment (selection bias)High riskInsufficient information provided by investigators but judgement based on the inadequacy of sequence generation
Blinding (performance bias and detection bias)
All outcomes
Unclear risk

Participants:
Quote (page 179): "Solutions of H2O2 and water were filled in identical bottles". "Several parents commented that their children could recognize that the experimental solution did not taste or smell like water"
Comment: unclear if the participants were adequately blinded to the intervention or control

Healthcare providers:
Quote: "Throughout the study...the investigators were blinded to the type of solution". However, the investigators stated both that "randomization was achieved by an unlabelled bottle system" and that the solutions "were filled in identical bottles and labelled with numbers"
Comment: in view of the lack of clarity as to how the allocation sequence was concealed we judged this criterion 'unclear'

Outcomes assessors and data analysts:
Pain was participant-assessed
Comment: judged 'unclear' due to inadequate blinding of participants to the interventions

Incomplete outcome data (attrition bias)
All outcomes
High riskQuote (page 180): "We chose to stop the recruitment of further patients because we realized that the H2O2 was not providing our patients with analgesic benefits"
Comment: substantial losses to follow-up; data analysis for only 37 out of 101 participants who completed the trial. Incomplete outcomes not adequately addressed
Selective reporting (reporting bias)Low risk

The protocol for the study was not available, but the prespecified outcomes and those mentioned in the methods section appear to have been reported

Comment: we judged this as at a low risk of bias

Other biasHigh risk

Unclear at what stage participants were randomised, if at all. The investigators reported that 101 participants were enrolled and that the participants were blindly randomised into 2 groups; 21 in the active group and 16 in the control group. In fact the 37 participants were those remaining after attritional losses during the course of the study

The trial was stopped early as reported due to perceived lack of analgesic benefits with hydrogen peroxide

Giacomelli 1984

MethodsRandomised, double-blind, placebo-controlled trial in Italy. Duration 5 days. Date and setting unspecified. Translated into English language prior to assessment
Participants

60 'eligible', 57 children (28 male, 29 female, age 4 to 17 years) completed the trial

INCLUSION CRITERIA: none specified

EXCLUSION CRITERIA: none specified

RANDOMISED: 60

WITHDRAWALS/TREATMENT FAILURES: 3 (no further details reported)

Interventions

Tonsillectomy; no further details reported

Intervention

  • Tantum Verde benzydamine spray (29)

Comparator

  • Placebo (28); similar packaging and smell/taste but without active ingredient

4 sprays 6 times/day for 5 days

OutcomesObjective and subjective symptom scores (4-point scale)
From translation: the observations were made immediately after the intervention and daily during treatment. Unclear who made the assessments, when and how many. Average pain scores day 1 to 5, and 8
Notes
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskFrom translation: sprays characterised by a random number and numbered packages
Comment: insufficient detail was reported about the method used to generate the allocation sequence to allow a clear assessment of whether it would produce comparable groups
Allocation concealment (selection bias)Unclear risk

The method used to conceal the allocation sequence, that is to determine whether intervention allocations could have been foreseen in advance of, or during, enrolment, was not reported

Comment: there was insufficient information to permit a clear judgement

Blinding (performance bias and detection bias)
All outcomes
Low risk

Participants:
From translation: similar packaging and smell/taste but without active ingredient

Comment: probably done

Healthcare providers:
Probably done

Outcomes assessors and data analysts:
Unclear who were the outcomes assessors, but probably done

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskVery limited data reported; there was insufficient information to permit a clear judgement of the risk of bias
Selective reporting (reporting bias)Unclear riskVery limited data reported; there was insufficient information to permit a clear judgement of the risk of bias
Other biasLow riskThe study appeared to be free of other sources of bias

Kaygusuz 2003

MethodsRandomised controlled trial in university and hospital ENT clinic in Turkey (March 1998 to July 2001)
Participants

80 children (47 male, 33 female; age 6 to 14 years)

INCLUSION CRITERIA:

  • Hypertrophy with obstructive symptoms, recurrent tonsillitis

EXCLUSION CRITERIA:

  • Acute pharyngeal infection, suspected malignant neoplasm, hypersensitivity to bupivacaine or lidocaine, regular consumption of analgesics hypnotics or sedatives

Interventions

Tonsillectomy (dissection technique with the snare method, haemostasis with compression and catgut sutures). Discharged same day

Intervention

  • Bupivacaine hydrochloride (0.25%) infiltrated around tonsil prior to surgery (20)

Comparator 1

  • Dexamethasone sodium phosphate (1 mg/kg) infiltrated around tonsil prior to surgery (20)

Comparator 2

  • Lidocaine HCl (10%) 4 mg/kg aerosol spray 4 doses 4 times a day postoperatively, number of days unreported (20)

Comparator 3

  • NaCl (9%) 2 ml aerosol spray 4 doses 4 times a day postoperatively, number of days unreported (20)

Postoperative medication

  • Antibiotic: oral amoxicillin (50 mg/kg) 5 days

  • Analgesics: type and quantity not specified other than "no narcotic used after surgery" and "all administered medications were carefully recorded"

Outcomes

Pain: postoperative assessment of "pain caused by drinking 100 ml of water" using a 10 cm VAS

  • Self assessed: day 1 (4-hourly); day 3; day 7

Notes

Outcome data were available for Group 3 and Group 4

It was unclear who sprayed the lidocaine, whether this was under general anaesthetic, and who sprayed for "4 times a day" and for how many days

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskQuote (page 738): "The patients were randomly assigned to each group"
Comment: insufficient detail was reported about the method used to generate the allocation sequence to allow a clear assessment of whether it would produce comparable groups
Allocation concealment (selection bias)Unclear risk

The method used to conceal the allocation sequence, that is to determine whether intervention allocations could have been foreseen in advance of, or during, enrolment, was not reported.

Comment: there was insufficient information to permit a clear judgement

Blinding (performance bias and detection bias)
All outcomes
Unclear risk

Participants:
Spray interventions were delivered intra-operatively under general anaesthesia and then for an unspecified period
Comment: participants effectively 'blinded' at operation but unclear if adequately blinded postoperatively

Healthcare providers:
Comment: unstated and unclear if/how the investigators were effectively blinded

Outcomes assessors and data analysts:
Postoperative pain was self evaluated and as the report was unclear as to whether the participants were adequately blinded the judgement is 'unclear'

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskQuote (page 738): "The analgesics were not administered to the patients separately in postoperative days. All administered medications were carefully recorded"
Comment: it was unclear if "analgesics" were permitted and the report did not provide any data
Selective reporting (reporting bias)Low risk

The protocol for the study was not available, but the prespecified outcomes and those mentioned in the methods section appeared to have been reported.

Comment: we judged this as at a low risk of bias

Other biasLow riskThe study appeared to be free of other sources of bias

Raj 1986

MethodsRandomised, placebo-controlled trial conducted in 2 hospitals in Manchester, UK (date unspecified). 2 study groups, adults and children
Participants

Adult study:
RANDOMISED: 100 enrolled; 86 (22 males age 14 to 32 mean 21.2 years, 64 females age 14 to 62 mean 21.7 years) completed the study

WITHDRAWALS: 14 excluded (8 incomplete data, 4 additional surgery, 2 due to defective spray)

Children's study:
RANDOMISED: 100 enrolled; 88 completed the study

WITHDRAWALS: 4 subsequently excluded due to prolonged admission and complications
Data available (84) 44 males, 40 females, age 4 to 8 years (58%), the rest 9 to 14 years

INCLUSION CRITERIA: only participants > 4 years

EXCLUSION CRITERIA: none specified

Interventions

Intervention

  • Benzydamine hydrochloride (0.15% W/V 1 puff 160 ml) (49)

Comparator

  • Matching placebo spray (37)

After tonsillectomy (technique unspecified), 2 to 3 puffs each side by surgeon
Postoperative: self or carer administered 2 puffs each side 3 times a day and as needed < 8 times/day. Adults for 3 days. Children discharged at 24 hours

Immediate postoperative: all patients received either "opiate injections or paracetamol/aspirin"

Postoperative/rescue medication: paracetamol and aspirin on demand

Outcomes

Dysphagia, sore throat and earache assessed on 5-point numerical scale (0 = no pain, 1 = minimal discomfort, 2 = occasional mild to moderate pain, 3 = continuous moderate pain, 4 = severe pain)
Adult: self assessment 3 times/day whilst admitted. Only global symptom scores reported (Group 1 no symptoms - Group 4 severe symptoms)
Children: questionnaires reviewed at recall < 2 weeks

Analgesic usage recorded

Notes
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk

Quote (page 303): "were randomly allocated to treatment" and "disclosure of randomized code"

Comment: insufficient detail was reported about the method used to generate the allocation sequence to allow a clear assessment of whether it would produce comparable groups

Allocation concealment (selection bias)Unclear risk

The method used to conceal the allocation sequence, that is to determine whether intervention allocations could have been foreseen in advance of, or during, enrolment, was not reported

Comment: there was insufficient information to permit a clear judgement

Blinding (performance bias and detection bias)
All outcomes
Low risk

Participants:
Quote: "The placebo resembled the active preparation in all details (e.g. taste, smell, colour)..."
Comment: probably done

Healthcare providers:
First administration intra-operatively by surgeons; unclear if sprays similarly packaged

Outcomes assessors and data analysts:
Self (participant) assessed and carer assessed
Probably done

Incomplete outcome data (attrition bias)
All outcomes
Low risk

Adult study: losses to follow-up/incomplete data (14/100) not entered into analysis but almost equal distribution between randomised groups

Childrens study: losses to follow-up/incomplete data (12/100) similar distribution between groups

Selective reporting (reporting bias)Low risk

The protocol for the study was not available, but the prespecified outcomes and those mentioned in the methods section appeared to have been reported

Comment: we judged this as at a low risk of bias

Other biasUnclear riskQuote (page 306): "Carnegie Medical made available the active and placebo materials used"
Comment: level of support unclear but otherwise free of other sources of bias

Schmidtmayer 1981

Methods

Randomised, double-blind, placebo-controlled trial in hospital ENT department in Ulm, Germany. Date not specified, duration 7 to 10 days

Translated into English language prior to assessment

Participants

65 (gender unreported; mean age 22 years)

INCLUSION CRITERIA:

  • Chronic tonsillitis

  • Additional diagnosis (such as adenoid hypertrophy)

EXCLUSION CRITERIA:

  • None specified

RANDOMISED: 65

WITHDRAWALS/TREATMENT FAILURES:

  • 4 (no further details reported, unclear from which group)

Interventions

Tonsillectomy; no further details reported

Intervention

  • Benzydamine hydrochloride (0.15% W/V) (33)

Comparator

  • Placebo (28)

At least 3 times a day gargling for 20 to 30 seconds for 7 days. Additional lozenge of acetylsalicylic acid during pain periods for both groups

Outcomes

Each day for 7 days

Objective assessment by physician of the therapeutic effect, uvula oedema, redness of palate, wound area, lymph node enlargement, pain in the neck, problems with swallowing, morning sickness, dryness of the mouth, vertigo, gastric discomfort, visual disturbances; 4-point Likert scale

Subjective assessment by the participant

Frequency of medication usage

Notes
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk

Quote (page 8288): "..war durch Zufallzuteilung ermittelt worden..." Translated as "was determined by random allocation"

Comment: insufficient detail was reported about the method used to generate the allocation sequence to allow a clear assessment of whether it would produce comparable groups

Allocation concealment (selection bias)Unclear risk

The method used to conceal the allocation sequence, that is to determine whether intervention allocations could have been foreseen in advance of, or during, enrolment, was not reported

Comment: there was insufficient information to permit a clear judgement

Blinding (performance bias and detection bias)
All outcomes
Unclear risk

Quote (page 8288): "...double-blind..."

Comment: the report did not provide sufficient detail about the measures used to blind the healthcare providers and the participants from knowledge of which intervention a participant received, to permit a clear judgement

Outcome assessors were both healthcare providers and participants

Uncertainty about the effectiveness of blinding of outcomes assessors during the study
Comment: insufficient information to permit a clear judgement

Incomplete outcome data (attrition bias)
All outcomes
Low risk

4/65 (6%), unclear from which group. Per-protocol analysis

Comment: low number of drop-outs at follow-up and although per-protocol analysis used, we considered this to be at low risk of bias

Selective reporting (reporting bias)Low risk

The protocol for the study was not available, but the prespecified outcomes and those mentioned in the methods section appeared to have been reported

Comment: we judged this as at a low risk of bias

Other biasUnclear riskUnclear to what extent the usage of concomitant anti-inflammatory medications may have confounded the treatment effect

Valijan 1989

MethodsRandomised, double-blind, placebo-controlled study (date and setting unspecified)
Participants

RANDOMISED: 31 (13 males, 18 females, age 17 to 32 years)

WITHDRAWALS: 2 losses in control group; 29 completed the study

INCLUSION CRITERIA: only adults < 16 years

EXCLUSION CRITERIA: none specified

Interventions

Intervention

  • Benzydamine hydrochloride (0.15% W/V) (15)

Comparator

  • Water spray supplied in 30 ml unmarked bottles (16)

< 4 sprays 3-hourly administered by nurse in postoperative period

Postoperative/rescue medication: paracetamol and aspirin and intravenous morphine as required

Outcomes

Self assessed in immediate postoperative period and 3 times/day for 24 hours: sore throat, earache, state of swallowing were recorded on a "linear analogue scale". No further details reported

Analgesic usage recorded but not reported

NotesRiker Laboratories provided the drug and matching placebo
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskQuote (page 990): "Randomly allocated to receive..."
Comment: insufficient detail was reported about the method used to generate the allocation sequence to allow a clear assessment of whether it would produce comparable groups
Allocation concealment (selection bias)Unclear risk

The method used to conceal the allocation sequence, that is to determine whether intervention allocations could have been foreseen in advance of, or during, enrolment, was not reported

Comment: there was insufficient information to permit a clear judgement

Blinding (performance bias and detection bias)
All outcomes
Unclear risk

Participants:
Quote (page 990): "the placebo resembled the active preparation in all aspects, such as taste, smell and colour"
Comment: unclear; placebo was water

Healthcare providers:
Quote (page 990): "Unmarked bottles..."
Comment: probably done

Outcomes assessors and data analysts:
Self (participant) assessed. In view of the uncertainty over the adequacy of blinding of participants, we judged this as 'unclear'

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskVery limited data reported; there was insufficient information to permit a clear judgement of the risk of bias
Selective reporting (reporting bias)High riskStudy objectives were relief of pain. Paucity of data on analgesic usage and unusable data reported as "eight hourly linear analogue scores"
Other biasUnclear riskRiker Laboratories provided the drug and matching placebo, and therefore unclear if free from other sources of bias

Young 1987

  1. a

    VAS = visual analogue scale

MethodsRandomised, double-blind, placebo-controlled trial conducted in North Devon District Hospital, UK (no date specified)
Participants

RANDOMISED: 56 enrolled (38 males, 18 females age 4 to 11, mean 7 years) completed the study

WITHDRAWALS: 1; analysed 55

INCLUSION CRITERIA: tonsillectomy

EXCLUSION CRITERIA: none specified

Interventions

Intervention

  • Difflam (benzydamine hydrochloride 0.15% W/V spray) (29)

Comparator

  • Placebo (no further details reported) (27)

Administered half an hour before meals for 48 hours postoperatively

OutcomesDiscomfort in the throat and ears; ability to swallow, pain assessment on 6-point scale (0 = no pain, 1 = minimum discomfort, 2 = occasional moderate pain, 3 = continuous moderate pain, 4 = continuous moderate to severe pain, 5 = severe pain)
NotesRiker Laboratories provided advice in setting up the study and Difflam and placebo
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskQuote (page 132): "they were randomly allocated by the ward sister"
Comment: insufficient detail was reported about the method used to generate the allocation sequence to allow a clear assessment of whether it would produce comparable groups
Allocation concealment (selection bias)Unclear risk

The method used to conceal the allocation sequence, that is to determine whether intervention allocations could have been foreseen in advance of, or during, enrolment, was not reported.

Comment: there was insufficient information to permit a clear judgement

Blinding (performance bias and detection bias)
All outcomes
Unclear risk

Participants and healthcare providers:
Quote: "study is based on the double-blind method so that neither the investigators nor the patients or their parents were aware whether or not they were taking active treatment..."
Comment: insufficient information to permit judgement of 'Yes' or 'No'

Outcomes assessors and data analysts:
The principal investigator was the outcome assessor: in view of uncertainty of blinding this judgement is unclear

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskVery limited data; there was insufficient information to permit a clear judgement of the risk of bias
Selective reporting (reporting bias)Low risk

Limited data in the report. Although the protocol for the study was not available, the prespecified outcomes and those mentioned in the methods section appeared to have been reported

Comment: we judged this as at a low risk of bias

Other biasUnclear riskThe involvement of Riker Laboratories in "setting up this study" might question whether the study is free of other sources of bias

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
  1. a

    BSG: bismuth subgallate
    RCT = randomised controlled trial
    CCT = controlled clinical trial

Canbay 2008

ALLOCATION
Quote: "...were randomly assigned..using the sealed opaque envelope technique based on computer generated random numbers"

PARTICIPANTS
60 children, aged 3 to 12 years scheduled for day case tonsillectomy

INTERVENTIONS
4 groups: ketamine in artificial saliva, ketamine and morphine aqueous solution + artificial saliva, morphine aqueous solution + artificial saliva, only artificial saliva. The interventions were described as a 'rinse' but were in fact 'solutions' instilled by the investigators

Chaturvedi 2005

ALLOCATION
Quote: "Patients were allocated randomly...by simple random sampling"

PARTICIPANTS
105, > 8 years

INTERVENTIONS
Gauze swab applied to the tonsillar fossa for 3 minutes intra-operatively. No further application. Interventions not relevant to this review

Egeli 2005

ALLOCATION
Quote: "...were randomised into two groups", but method of randomisation unspecified

PARTICIPANTS
40 children, 4 to 16 years

INTERVENTIONS
Swabs packed intra-operatively into the tonsillar fossae for 5 minutes. Interventions not relevant to this review

Eigel 1981Full text unobtainable
Elhakim 1995

ALLOCATION
Quote: "Randomly allocated to one of three groups". Preoperative/postoperative/nil. 'Randomised' to timing of intervention

PARTICIPANTS
75 children 4 to 6 years

INTERVENTIONS
Topical lidocaine spray, but control group was 'no treatment'

Falbe-Hansen 1974

ALLOCATION
Consecutive patients; non-RCT

PARTICIPANTS
1050, no further details

INTERVENTIONS
Tranexamic acid (antifibrinolytic) versus placebo, on sterile gauze packs

Interventions not relevant to this review

Feng 2007

ALLOCATION
CCT; non-RCT

Study obtained and translated by Prof Ming Ming Zhang (Chinese Cochrane Centre). See Acknowledgements

Gilani 1999ALLOCATION
Non-RCT. Quote: "...the patients were divided into two groups of 100 each". See reference (Nabi 2000)
Gross 2001

ALLOCATION
Quote: "Patients were randomly assigned"

PARTICIPANTS
20; 5 to 17 years

INTERVENTIONS
Fibrin sealant, intervention not relevant to this review

Hung 2002

ALLOCATION
Quote: "Randomised into two groups using sealed envelopes"

PARTICIPANTS
99, 3 to 16 years

INTERVENTIONS
Intra-operative swabs packed into tonsillar fossae for 5 minutes. Interventions not relevant to this review

Irwin 1984ALLOCATION
CCT
Jo 2007

ALLOCATION
RCT. Quote: "...randomized from a computerized number chart"

PARTICIPANTS
68, 2 to 16 years

INTERVENTIONS
Comparison of FloSeal against electrocautery. Interventions not relevant to this review

Jurkiewicz 2004

ALLOCATION
Quote: "Divided into two groups"; CCT

PARTICIPANTS
200, 16 to 52 years

INTERVENTIONS
Fusafungine, but control was a 'no treatment' group

Kadar 2003ALLOCATION
Non-RCT
Quote: "Seventy-two consecutive patients....." "...the right and left tonsillar fossae were labelled as subject and control fossae respectively"
Khan 2005ALLOCATION
Quote: "Divided into two groups"; non-RCT
Lee 2002ALLOCATION
Non-RCT. Quote: "At the end of surgery, the patients were divided into three groups"
Lukan 2002

ALLOCATION
Quote: "Open, randomised study"; CCT

PARTICIPANTS
68, 15 to 55 years

INTERVENTIONS
Fusafungine spray. Control group was 'no treatment'

Nabi 2000ALLOCATION
Non-RCT
NCT01434017

ALLOCATION

Quote: "Randomized"

PARTICIPANTS

300, 2 to 10 years

INTERVENTIONS

Dexamethasone alone (250 µg/kg), dexamethasone (250 µg/kg) + droperidol (10 µg/kg) and dexamethasone (250 µg/kg) + ondansetron (150 µg/kg) intravenously just after induction of anaesthesia. Interventions not relevant to this review

NCT01498796

ALLOCATION

Quote: "Randomized"

PARTICIPANTS

Number unknown, 3 to 15 years

INTERVENTIONS

Ketorolac versus normal saline (parenteral). Interventions not relevant to this review

NCT01582022

ALLOCATION

Quote: "Randomized" and "to insure the random selection, the tested and control sides will be selected based on unpredicted method e.g. based on the last number in pt MRN: If the last # is even (0, 2, 4, 6, 8) = right side will be the tested If the last # is odd (1, 3, 5, 7, 9) = left side will be the tested". Quasi-randomised

PARTICIPANTS

35, age selection not provided

INTERVENTIONS

Bupivacaine local application for 5 minutes and normal saline local application for 5 minutes. Interventions not relevant to this review

NCT01707420

ALLOCATION

Quote: "Randomized"

PARTICIPANTS

75, 5 to 16 years

INTERVENTIONS

Gabapentin, 20 mg/kg, single dose, 60 min prior to surgery versus placebo. Interventions not relevant to this review

NCT01837810

ALLOCATION

Quote: "Randomized"

PARTICIPANTS

810, > 18 years

INTERVENTIONS

Ibuprofen versus methylcellulose orally. Interventions not relevant to this review

Oghan 2008

ALLOCATION
Quote: "Randomization was provided by the use of random number generator"

PARTICIPANTS
41, 4 to 16 years

INTERVENTIONS
Intra-operative swabs packed into tonsillar fossae for 5 minutes. Interventions not relevant to this review

Pande 1970

ALLOCATION
Non-RCT. Quote: "Twenty five sprays contained the active ingredient and were randomized amongst 25 placebo containing sprays"

PARTICIPANTS
50, 18 to 29 years

INTERVENTIONS
Spray benzocaine + cetalkonium chloride versus placebo

Purser 2000

ALLOCATION
Quote: "Matched pairs randomization technique"

PARTICIPANTS
64, 3 to 15 years

INTERVENTIONS
Intra-operative infiltration of ropivacaine into tonsillar bed. Intervention: participants randomised to cotton wool balls soaked with either pure ethanol or normal saline applied to the tonsillar bed. This study solely assessed the adjunctive benefits of ethanol to infiltration of ropivacaine. Interventions not relevant to this review

Rehman 2012

ALLOCATION

Non-randomised

Rustamov 1978ALLOCATION
Cohort study, non-RCT (translated by V. Vlassov). See Acknowledgements
Schlorhaufer 1965

ALLOCATION
Not available

PARTICIPANTS
Not available

INTERVENTIONS
Not available. Control group 'no treatment' (translated Nicole Skoetz). See Acknowledgements

Violaris 1989ALLOCATION
Quote: "...alternative patients"; CCT
Quote: "Alternative patients had either the right or left tonsillar fossa exposed to 10 ml of bupivacaine...."
Wong 1995

ALLOCATION
Quote: "Randomly allocated to treatment"

PARTICIPANTS
43, 2 to 10 years

INTERVENTIONS
Normal saline spray, bupivacaine + epinephrine peri-tonsillar injection, bupivacaine + epinephrine spray, all were administered intra-operatively

Wormald 1994ALLOCATION
CCT. Quote: "Patients were randomized to receive BSG according to theatre list"
Özkiris 2011

ALLOCATION

Non-randomised

Characteristics of ongoing studies [ordered by study ID]

IRCT201104236256N1

  1. a

    FLACC scale: Face, Legs, Activity, Cry, Consolability scale

Trial name or titleComparison the effect of topical ketamine, morphine and lidocaine spray on postoperative pain in tonsillectomy
MethodsRandomised, controlled, non-blinded, active and placebo-controlled trial
Participants

RANDOMISED: 124 enrolled (age 3 to 12 years)

INCLUSION CRITERIA: tonsillectomy

EXCLUSION CRITERIA: use anticonvulsive, anti-inflammatory or analgesic agents, history of hypersensitive reactions to morphine or lidocaine, hyperactive airway disease such asthma

Interventions

Intervention

  • Lidocaine spray 10% (100 mg/ml) with dose 2 mg/kg

Comparator 1

  • Ketamine spray 1% (10 mg/ml) with dose 0.5 mg/kg

Comparator 2

  • Morphine spray 0.1% (1 mg/ml) with dose 0.05% mg/kg

Comparator 3

  • Normal saline spray

The premedication, induction and maintenance of anaesthesia in all of patient will be similar. At the end of surgery the interventions will be used on the surface of surgery zone

OutcomesPain scaling will be assessed for 1 hour (with 20-minute intervals) by personnel who are not aware of the research methods. Pain control will be scaled with the FLACC Pain Scaling System. If any patient in the recovery room complains of severe pain (score 6 or more) they will receive pethidine 0.5 mg/kg for relief
Starting date22 June 2010
Contact information

Dr Sevak Hatamian - Qazvin University of Medical Sciences

Anaesthesia Resident

Contact details:

Shahid Bahonar Blvd

Qazvin

Iran

+982812222452

+989121986270

sehatamian@qums.ac.ir

NotesRecruitment complete no further details: http://www.irct.ir/searchresult.php?id=6256&number=1

Ancillary