Intervention Review

You have free access to this content

Oral rinses, mouthwashes and sprays for improving recovery following tonsillectomy

  1. Zbys Fedorowicz1,*,
  2. Esther J van Zuuren2,
  3. Mona Nasser3,
  4. Ben Carter4,
  5. Jassim H Al Langawi5

Editorial Group: Cochrane Ear, Nose and Throat Disorders Group

Published Online: 10 SEP 2013

Assessed as up-to-date: 4 JUL 2013

DOI: 10.1002/14651858.CD007806.pub4


How to Cite

Fedorowicz Z, van Zuuren EJ, Nasser M, Carter B, Al Langawi JH. Oral rinses, mouthwashes and sprays for improving recovery following tonsillectomy. Cochrane Database of Systematic Reviews 2013, Issue 9. Art. No.: CD007806. DOI: 10.1002/14651858.CD007806.pub4.

Author Information

  1. 1

    The Cochrane Collaboration, UKCC (Bahrain Branch), Awali, Bahrain

  2. 2

    Leiden University Medical Center, Department of Dermatology, Leiden, Netherlands

  3. 3

    University of Plymouth, Peninsula Dental School, Plymouth, UK

  4. 4

    Cardiff University School of Medicine, Institute of Primary Care & Public Health, Cardiff, UK

  5. 5

    AMA International University, College of Medicine, Salmabad, Bahrain

*Zbys Fedorowicz, UKCC (Bahrain Branch), The Cochrane Collaboration, Box 25438, Awali, Bahrain. zbysfedorowicz@gmail.com.

Publication History

  1. Publication Status: New search for studies and content updated (no change to conclusions)
  2. Published Online: 10 SEP 2013

SEARCH

 

Summary of findings    [Explanations]

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms

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

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

ControlLidocaine

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)
⊕⊕⊝⊝
low1,2

*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.

 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.

 

Background

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms
 

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

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms

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

 

Methods

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms
 

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

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms
 

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.

 FigureFigure 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).

 FigureFigure 2. 'Risk of bias' graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
 FigureFigure 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).

 FigureFigure 4. Forest plot of comparison: 1 Pain severity, outcome: 1.1 Day 1.
 FigureFigure 5. Forest plot of comparison: 1 Pain severity, outcome: 1.2 Day 3.
 FigureFigure 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

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms
 

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

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms

 

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.

 

Acknowledgements

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms

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

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms
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]

 

Appendices

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms
 

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

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms

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


DateEventDescription

30 August 2013New citation required but conclusions have not changedOne 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

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms

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

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms

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

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms

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

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms
 

Internal sources

  • None, Not specified.

 

External sources

  • None, Not specified.

 

Differences between protocol and review

  1. Top of page
  2. Summary of findings    [Explanations]
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Index terms

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.

* Indicates the major publication for the study

References

References to studies included in this review

  1. Top of page
  2. Abstract
  3. Summary of findings
  4. Background
  5. Objectives
  6. Methods
  7. Results
  8. Discussion
  9. Authors' conclusions
  10. Acknowledgements
  11. Data and analyses
  12. Appendices
  13. What's new
  14. History
  15. Contributions of authors
  16. Declarations of interest
  17. Sources of support
  18. Differences between protocol and review
  19. Characteristics of studies
  20. References to studies included in this review
  21. References to studies excluded from this review
  22. References to ongoing studies
  23. Additional references
  24. References to other published versions of this review
Abou Chacra 2005 {published data only}
  • Abou Chacra Z, Manoukian JJ, Schloss MD, Tewfik TL. A prospective randomized double-blinded clinical trial on the effect of hydrogen peroxide mouth rinse for pain control after tonsillectomy. 58th Annual Meeting of the Canadian Society of Otolaryngology - Head and Neck Surgery, Quebec City. 2004.
  • Chacra ZA, Manoukian JJ, Al Qahtani K, Al Eisa M, Balys R, Hagr A, et al. Hydrogen peroxide mouth rinse: an analgesic post-tonsillectomy. Journal of Otolaryngology 2005;34(3):178-82.
Giacomelli 1984 {published data only}
  • Giacomelli F, Pastore F, Zangari M, Marchiori C, Soranzo GP. Tonsillectomies: postoperative therapy using 'Tantum Verde' spray [Tonsillectomie: terapia post-operatoria con Tantum Verde nebulizzatore]. Gazzetta Medica Italiana 1984;143(7-8):639-44.
Kaygusuz 2003 {published data only}
  • Kaygusuz I, Susaman N. The effects of dexamethasone, bupivacaine and topical lidocaine spray on pain after tonsillectomy. International Journal of Pediatric Otorhinolaryngology 2003;67(7):737-42.
Raj 1986 {published data only}
Schmidtmayer 1981 {published data only}
  • Schmidtmayer EK, Meyer F. On the use of Tantum Verde, a benzydamine based gargling solution, after tonsillectomy [Űber die Anwendung von Tantum® Verde, einer Gurgellösung auf Benzydaminbasis, nach Tonsillektomie]. Therapiewoche 1981;31(49):8288-93.
Valijan 1989 {published data only}
Young 1987 {published data only}
  • Young JR. A comparative study of benzydamine hydrochloride ('Difflam' pump spray) and placebo as analgesics following tonsillectomy. International Journal of Tissue Reactions 1987;9(2):131-3.

References to studies excluded from this review

  1. Top of page
  2. Abstract
  3. Summary of findings
  4. Background
  5. Objectives
  6. Methods
  7. Results
  8. Discussion
  9. Authors' conclusions
  10. Acknowledgements
  11. Data and analyses
  12. Appendices
  13. What's new
  14. History
  15. Contributions of authors
  16. Declarations of interest
  17. Sources of support
  18. Differences between protocol and review
  19. Characteristics of studies
  20. References to studies included in this review
  21. References to studies excluded from this review
  22. References to ongoing studies
  23. Additional references
  24. References to other published versions of this review
Canbay 2008 {published data only}
Chaturvedi 2005 {published data only}
  • Chaturvedi S, Domkondwar UG. A comparative study of topical analgesia with 4% lignocaine and 0.5% bupivacaine following tonsillectomy. Indian Journal of Anaesthesia 2005;49(2):113-5.
Egeli 2005 {published data only}
  • Egeli E, Harputluoglu U, Oghan F, Demiraran Y, Guclu E, Ozturk O. Does topical lidocaine with adrenaline have an effect on morbidity in pediatric tonsillectomy?. International Journal of Pediatric Otorhinolaryngology 2005;69(6):811-15.
Eigel 1981 {published data only}
Elhakim 1995 {published data only}
  • Elhakim M, Abdel-Hay H. Comparison of preoperative with postoperative topical lidocaine spray on pain after tonsillectomy. Acta Anaesthesiologica Scandinavica 1995;39(8):1032-5.
Falbe-Hansen 1974 {published data only}
  • Falbe-Hansen J Jr, Jacobsen B, Lorenzen E. Local application of an antifibrinolytic in tonsillectomy. A double-blind study. Journal of Laryngology and Otology 1974;88(6):565-8.
Feng 2007 {published data only}
  • Feng H, Hu Y. The clinical observation on the therapeutic effect of Houyou spray in post tonsillectomy. International Medicine and Health Guidance News 2007;13(3):55-6.
Gilani 1999 {published data only}
  • Gilani SM, Nabi G, Ghazal S. Postoperative analgesia - effect of topical bupivacaine after tonsillectomy - a clinical study. Journal of Ayub Medical College 1999;11(2):9-12.
Gross 2001 {published data only}
Hung 2002 {published data only}
  • Hung T, Moore-Gillon V, Hern J, Hinton A, Patel N. Topical bupivacaine in paediatric day-case tonsillectomy: a prospective randomized controlled trial. Journal of Laryngology and Otology 2002;116(1):33-6.
Irwin 1984 {published data only}
  • Irwin BC, Acharya KB. A comparative study of benzydamine hydrochloride 0.15% w/v ('Difflam' oral rinse) and acetyl salicylic acid as analgesics following tonsillectomy. Journal of International Medical Research 1984;12(3):216-8.
Jo 2007 {published data only}
  • Jo SH. Randomized controlled trial of FloSeal in adenotonsillectomy. Otolaryngology - Head and Neck Surgery 2006;135(2 Suppl):P94.
  • Jo SH, Mathiasen RA, Gurushanthaiah D. Prospective, randomized controlled trial of a hemostatic sealant in children undergoing adenotonsillectomy. Otolaryngology - Head and Neck Surgery 2007;137(3):454-8.
Jurkiewicz 2004 {published data only}
  • Jurkiewicz D, Wojdas A, Rapiejko P, Kantor I, Hermanowski M, Usowski J, et al. Application of the fusafungine in perioperative period in patients after tonsillectomy. Polski Merkuriusz Lekarski 2004;16(94):358-61.
Kadar 2003 {published data only}
  • Kadar AA, Obaid MA. Effect on postoperative pain after local application of bupivacaine in the tonsillar fossa; a prospective single blind controlled trial. Journal of the Pakistan Medical Association 2003;53(9):422-6.
Khan 2005 {published data only}
  • Khan SA, Zaman J. Effect of topical bupivacaine on postoperative pain after tonsillectomy. Medical Channel 2005;11(2):30-3.
Lee 2002 {published data only}
  • Lee DH, Yang EW. The effect of 10% lidocaine spray and intravenous ketorolac for pain relief after a tonsillectomy. Korean Journal of Anesthesiology 2002;43(2):191-7.
Lukan 2002 {published data only}
Nabi 2000 {published data only}
  • Nabi G. Postoperative analgesia effect of topical bupivacaine after tonsillectomy. A clinical study. 2nd International SAARC ENT Congress, Katmandu Nepal. Extending ENT Services to the Community. 2000.
NCT01434017 {unpublished data only}
  • NCT01434017. Comparison of Three Different Prophylactic Treatments of Postoperative Nausea and Vomiting (PONV) in Children. www.clinicaltrials.gov.
NCT01498796 {unpublished data only}
  • NCT01498796. KITS Study - Ketorolac In Tonsillectomy Surgery: a Double Blinded, Randomized Clinical Trial. www.clinicaltrials.gov.
NCT01582022 {unpublished data only}
  • NCT01582022. Evaluation of The Effect of Bupivacaine (Marcaine) in Reducing Early Post Tonsillectomy Pain. www.clinicaltrials.gov.
NCT01707420 {unpublished data only}
  • NCT01707420. Preoperative Gabapentin for Post-tonsillectomy Pain in Children. www.clinicaltrials.gov.
NCT01837810 {unpublished data only}
  • NCT01837810. NSAID Post-Tonsillectomy Hemorrhage: A Randomized, Double-Blinded Controlled Noninferiority Trial. www.clinicaltrials.gov.
Oghan 2008 {published data only}
  • Oghan F, Harputluoglu U, Guclu E, Kocaman B, Ozturk O. Does topical ropivacaine reduce the post-tonsillectomy morbidity in pediatric patients?. International Journal of Pediatric Otorhinolaryngology 2008;72(3):361-5.
Özkiris 2011 {published data only}
  • Özkırıs M, Mutlu C. The effects of post-operative topical chlorhexidine gluconate and benzydamine HCL spray (farhex) on post-operative pain and oral intake in tonsillectomied patients. Journals of Medicine and Medical Sciences 2011;2(10):1143-6.
Pande 1970 {published data only}
  • Pande YN. Double-blind controlled trial of a throat spray containing benzocaine and cetalkonium chloride on postoperative adult tonsillectomy patients. British Journal of Clinical Practice 1970;24(6):253-4.
Purser 2000 {published data only}
  • Purser S, Royse CF, Velkov HA, Roberts LF. Topical application of ethanol to the tonsillar bed immediately following tonsillectomy does not improve post-operative analgesia. Journal of Laryngology and Otology 2000;114(9):671-4.
Rehman 2012 {published data only}
  • Rehman HU, Wahid FI, Juvaid M, Khan A, Kahn IA. Efficacy of benzydamine hydrochloride in treatment of post-tonsillectomy patients in a tertiary care hospital. Gujarat Journal of Otorhinolaryngology and Head and Neck Surgery 2012;9(1):8-10.
Rustamov 1978 {published data only}
  • Rustamov FN, Guseinov OM. Effect on blood loss of the local use of epsilon-aminocaproic acid and ascorbic acid with an anesthetic (Novocain) during and after tonsillectomy. Zhurnakl Ushnikh Nosovokh i Gorlovikh Bolezney 1978;4:27-8.
Schlorhaufer 1965 {published data only}
  • Schlorhaufer W, Seeber F, Semenitz E. Studies on the postoperative course of tonsillectomy (based on clinical and bacteriological principles and using Terra-Cortyl sprays) [Untersuchungen zum postoperativen Verlauf nach Tonsillektomie. (Nach klinischen uns bakteriologischen Gesichtspunkten und unter Verwendung des Terra-Cortril-Sprays)]. Monatsschrift fur Ohrenheilkunde und Laryngo-Rhinologie 1965;99(7):309-20.
Violaris 1989 {published data only}
Wong 1995 {published data only}
  • Wong AK, Bissonnette B, Braude BM, Macdonald RM, St Louis PJ, Fear DW. Post-tonsillectomy infiltration with bupivacaine reduces immediate postoperative pain in children. Canadian Journal of Anaesthesia 1995;42(9):770-4.
Wormald 1994 {published data only}

Additional references

  1. Top of page
  2. Abstract
  3. Summary of findings
  4. Background
  5. Objectives
  6. Methods
  7. Results
  8. Discussion
  9. Authors' conclusions
  10. Acknowledgements
  11. Data and analyses
  12. Appendices
  13. What's new
  14. History
  15. Contributions of authors
  16. Declarations of interest
  17. Sources of support
  18. Differences between protocol and review
  19. Characteristics of studies
  20. References to studies included in this review
  21. References to studies excluded from this review
  22. References to ongoing studies
  23. Additional references
  24. References to other published versions of this review
Brown 2006
Burton 2004
  • Burton MJ, Doree CJ. Harmonic scalpel versus other surgical procedures for tonsillectomy. Cochrane Database of Systematic Reviews 2004, Issue 1. [DOI: 10.1002/14651858.CD004616]
Burton 2007
Burton 2009
Chacra 2005
  • Chacra ZA, Manoukian JJ, Al-Qahtani K, Al-Eisa M, Balys R, Hagr A, et al. Hydrogen peroxide mouth rinse: an analgesic post-tonsillectomy. Journal of Otolaryngology 2005;34(3):178-82.
DynaMed 2013
  • Tonsillectomy. DynaMed [database online] EBSCO Publishing, 2013. http://search.ebscohost.com/login.aspx?direct=true&db=dme&AN=114262&site=dynamed-live&scope=site (accessed 25 July 2013).
Grainger 2008
Hicks 2001
Higgins 2011
  • Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org.
Hoddeson 2008
  • Hoddeson EK, Gourin CG. Adult tonsillectomy: current indications and outcomes. Otolaryngology - Head and Neck Surgery 2008;139(2):33.
Hollis 1999
  • Hollis LJ, Burton MJ, Millar JM. Perioperative local anaesthesia for reducing pain following tonsillectomy. Cochrane Database of Systematic Reviews 1999, Issue 4. [DOI: 10.1002/14651858.CD001874]
Kotiniemi 1997
  • Kotiniemi LH, Ryhänen PT, Valanne J, Jokela R, Mustonen A, Poukkula E. Postoperative symptoms at home following day-case surgery in children: a multicentre survey of 551 children. Anaesthesia 1997;52(10):963–9.
Lee 1996
Lee 2004
Leinbach 2003
Lim 2001
  • Lim J, McKean M. Adenotonsillectomy for obstructive sleep apnoea in children. Cochrane Database of Systematic Reviews 2001, Issue 3. [DOI: 10.1002/14651858.CD003136]
Mann 1999
Pai 2005
  • Pai I, Lo S, Brown S, Toma AG. Does hydrogen peroxide mouthwash improve the outcome of secondary post-tonsillectomy bleed? A 10-year review. Otolaryngology - Head and Neck Surgery 2005;133(2):202-5.
Pinder 2011
Ramsden 2005
  • Ramsden R. National Prospective Tonsillectomy Audit. Royal College of Surgeons of England 2005:1-52.
Raut 2001
RevMan 2012
  • The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). 5.2. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2012.
Romsing 2000
Schloss 1994
  • Schloss MD, Tan AK, Schloss B, Tewfik TL. Outpatient tonsillectomy and adenoidectomy: complications and recommendations. International Journal of Pediatric Otorhinolaryngology 1994;30(2):115-22.
Walker 2007
  • Walker P, Gillies D. Post-tonsillectomy hemorrhage rates: are they technique-dependent?. Otolaryngology - Head and Neck Surgery 2007;136(4 Suppl):S27-31.

References to other published versions of this review

  1. Top of page
  2. Abstract
  3. Summary of findings
  4. Background
  5. Objectives
  6. Methods
  7. Results
  8. Discussion
  9. Authors' conclusions
  10. Acknowledgements
  11. Data and analyses
  12. Appendices
  13. What's new
  14. History
  15. Contributions of authors
  16. Declarations of interest
  17. Sources of support
  18. Differences between protocol and review
  19. Characteristics of studies
  20. References to studies included in this review
  21. References to studies excluded from this review
  22. References to ongoing studies
  23. Additional references
  24. References to other published versions of this review
Fedorowicz 2010
Fedorowicz 2011