Interventions for increasing acceptance of local anaesthetic in children having dental treatment

  • Protocol
  • Intervention

Authors


Abstract

This is the protocol for a review and there is no abstract. The objectives are as follows:

To evaluate the effects of methods for acceptance of local anaesthetic in children during dental treatment.

Background

Dental caries remains a serious problem in children, affecting 37.9% of five-year olds in England and 27.9% of two- to five-year olds in the United States of America (NHANES 2004; Davies 2013). If untreated, caries may lead to pain, infection, malnutrition and disturbed growth (Acs 1999; Low 1999). Social and financial consequences may include days off school or work, referral to specialised care and general anaesthetic resulting in increased costs (Thikkurissy 2010). Surgical approaches and new preventive strategies have been developed and widely researched (Innes 2007; Kandiah 2010). Once dentinal caries is established, restorative or surgical treatment is needed, traditionally requiring local anaesthetic.

Description of the condition

Dental anxiety is a well-known barrier to treatment, commonly developing during childhood or adolescence (Locker 1999). Early onset of dental anxiety may have significant consequences, being associated with behavioural problems that may lead to increased pain perception and interference with the treatment provided (Klingberg 1995; Ayer 2005; van Wijk 2008). Ultimately, children's dental anxiety may lead to avoidance of treatment and irregular attendance in adulthood (Skaret 2003).

The aetiology of dental anxiety is multifactorial. Children's cognitive abilities, parental anxiety and previous negative dental or medical experiences seem to play a crucial role in the development of dental anxiety (Townend 2000; Versloot 2008). Invasive procedures, injections and drilling in particular, appear to be the most anxiety-inducing treatments in children (Majstorovic 2004).

Dental injection phobia is a subtype of blood-injury-injection phobia. Milgrom considers general fear of injections, including pain and fear of injury, to be the main aspects of dental injection fear (Milgrom 1997). In children, needle phobia was found to be significant, with a prevalence of 19% in four- to six-year olds. Fear of needles seems to decrease with age, possibly due to cognitive maturation or development of coping behaviours (Majstorovic 2004). Nevertheless, a prevalence of 11% for 10- to 11-year olds and for 18-year olds, show the significant importance of fear of intraoral injections (Majstorovic 2004; Vika 2008). Furthermore, authors have found a strong relationship between blood-injury-injection phobia and dental anxiety (Vika 2008). Additionally, dental anxiety and pain of injection seem to be strongly correlated, with highly anxious patients reporting increased pain perception and duration (van Wijk 2008). Weisman showed that inadequate analgesia for invasive medical procedures in young children may reduce the effect of appropriate analgesia in the future (Weisman 1998). Similarly, it appears that previous experiences with dental injections may lead to behavioural problems in subsequent treatment sessions (Versloot 2008).

Delivery of pain-free dentistry is crucial for reducing fear and anxiety, facilitating delivery of treatment, developing a trusting dentist/patient relationship and accepting future treatment. Delivery of local anaesthetic is a vital part of this, however it remains one of the most challenging aspects of paediatric dentistry.

Description of the intervention

Delivery of high quality dentistry to children is closely linked to a non-threatening approach and pain-free treatment. A number of behaviour management techniques have been proposed and are consistently applied during treatment, in order to achieve successful outcomes (Campbell 2011; Ashley 2012; Lourenço-Matharu 2012). Delivery and acceptance of dental local anaesthetic is one of the most trying aspects of treatment. In order to facilitate this, several specific techniques and materials have been developed and researched. This review will focus on interventions specifically used for delivery of local anaesthetic. The use of other behaviour management techniques is implied during all steps of dental treatment. Although these may indirectly influence acceptance of local anaesthetics, they will not be discussed.

Meechan described three factors that influence discomfort during delivery of local anaesthetic: factors related to the patient, equipment factors and aspects that are under control of the dentist (Meechan 2009). The two latter will be the focus of this review.

1. Patient factors

As previously discussed, dental anxiety seems to have a multifactorial aetiology, being closely related to child psychological factors (ten Berge 1999). The level of generalised anxiety and psychological function seem to be determinant factors in children's dental anxiety (Versloot 2008; Krikken 2010). This may, in turn, influence children's acceptance to dental treatment, including delivery of local anaesthetic.

2. Equipment factors

The use of visual or auditory technology has been suggested as a distraction technique in order to reduce anxiety and pain perception during delivery of dental treatment (including local anaesthetic) for children.

Baghdadi 2000; Aitken 2002; Marwah 2005 and Prabhakar 2007 studied the effect of music distraction on anxiety, pain or behaviour for children undergoing dental treatment with local anaesthetic. Similarly, the use of videos either prior or during treatment (including audiovisual glasses) has been studied as a possible distraction technique by Melamed 1975; Ingersoll 1984; Ram 2010; Aminabadi 2012; El-Sharkawi 2012 and Hoge 2012. These were used independently or in conjunction with pharmacological behaviour management techniques.

Although topical anaesthetic is commonly used, controversy remains on its efficacy in reducing pain of dental injections in children (Meechan 1994; Tulga 1999; Kreider 2001; Primosch 2001; Nayak 2006; Paschos 2006; Berg 2007; Bågesund 2008; Deepika 2012). Similarly, Aminabadi 2009a studied the effect of pre-cooling the injection site, followed by topical anaesthetic, for delivery of local anaesthetic. The gauge or length of the needle (Brownbill 1987; Ram 2007) and the temperature of the cartridge (Ram 2002) have equally been investigated for their influence on pain perception and anxiety of children during delivery of local anaesthetic.

In recent years, several electronic delivery devices for local anaesthetic have been developed, that promote distraction by vibration, needleless injections or transcutaneous electrical nerve stimulation.

The influence of electronic devices for infiltration or intraligamental anaesthesia on children's anxiety and pain has been investigated by a number of authors (Wilson 1999; Baghdadi 2000; Palm 2004; Oztaş 2005; Versloot 2005; Ram 2006; Kuscu 2008; Versloot 2008; Tahmassebi 2009; Hembrecht 2013; Nieuwenhuizen 2013). Sixou 2008 studied treatment success rates following local anaesthetic with an electronic device for intraosseous local anaesthetic. In 2009, the same author assessed children's pain perception using the same device (Sixou 2009). Roeber evaluated the effects of using a vibrating attachment to the syringe for local anaesthetic in children (Roeber 2011). Arapostathis compared acceptance, preference and efficacy of a needleless injection device when compared to conventional syringes in children (Arapostathis 2010). Similarly, transcutaneous nerve stimulation was studied as an alternative to conventional local anaesthetic in children (Harvey 1995; Oztaş 1997; Munshi 2000).

3. Dentist factors

3.1 Non-pharmacological interventions

Non-pharmacological interventions have been suggested in order to increase acceptance of local anaesthetic. These methods may include verbal distraction by the dentist, the use of non-threatening words (or 'childrenese') to describe dental injections (Fayle 1997), imagery suggestion, systematic desensitisation or counter stimulation during local anaesthetic.

A number of case reports and review articles have focused on systematic desensitisation for dental treatment in children. Although several randomised controlled trials have been undertaken in adults, there is a paucity of these studies in children (Levitt 2000). A distraction technique involving repeated breathing and blowing out air was studied as an alternative distraction for children receiving dental local anaesthetic (Peretz 1999). The same author studied the benefits of imagery suggestion during delivery of local anaesthetic for children's dental treatment. This technique involves selection of a pleasant image in which the child is asked to concentrate during treatment (Peretz 2000). Aminabadi studied the influence of counter stimulation and distraction on pain perception of children during delivery of local anaesthetic (Aminabadi 2008).

Hypnosis has been used and researched for delivery of treatment and local anaesthetic (Al-Harasi 2010; Huet 2011). Viewing/hiding the needle prior to injection has also been subject of research (Maragakis 2006). Several authors found that the time taken to deliver local anaesthetic has an influence on injection pain (Jones 1995; Maragakis 1996). Similarly, the site of injection may influence pain perception and anxiety, hence certain authors suggesting adoption of treatment sequences that contemplate these parameters (Aminabadi 2009b).

3.2 Pharmacological interventions

Ultimately, pharmacological techniques such as inhalation, oral, intranasal or intravenous sedation have been widely used as adjuvants to delivery and acceptance of local anaesthetic. A recent Cochrane systematic review investigated the efficacy of conscious sedation for paediatric dental treatment (Lourenço-Matharu 2012). The authors found weak and very weak evidence supporting the effectiveness of oral midazolam and nitrous oxide, respectively.

In general terms, interventions were considered successful when treatment was completed or anxiety and pain reduced in comparison to control groups. These interventions are aimed at increasing acceptance of local anaesthetic, often with completion of the proposed dental treatment as an end result. In other studies, authors undertook assessments of children's pain and anxiety by using physiological assessment questionnaires or interviews, anxiety scales and behavioural assessment (Peretz 2000; Sixou 2009).

How the intervention might work

Provision of pain and anxiety-free local anaesthetic is of utmost importance. A number of interventions to help children cope with delivery of local anaesthetic have been discussed in the literature.

A common aim of interventions is to reduce pain and anxiety during injection. Equipment factors may work differently in order to achieve this goal: music and audiovisual technologies aim to redirect the child's attention away from the procedure. Furthermore, it has been suggested that music provides comfort and induces relaxation at a neurological level (Bradt 2013). The use of topical anaesthetic, the influence of the gauge of the needle, site (order) of injection and time taken to deliver local anaesthetic are all factors that have implications on pain perception during injection (Meechan 2009). One may argue that an additional benefit of topical anaesthetic may be reassurance of using an anaesthetic agent prior to injection. The use of electronic devices, similarly, may influence pain perception during delivery of local anaesthetic. These devices may also benefit from a different appearance to traditional syringes, possibly increasing children's acceptance (Kuscu 2008). Clinician's factors as counter stimulation, breathing techniques or imagery suggestion may act as distraction methods. The two latter also aim to induce relaxation (Peretz 2000). Similarly, systematic desensitisation will promote a relaxed state, while exposing children to fear-inducing stimuli (Levitt 2000). Finally hypnosis will very similarly work by redirecting children's attention away from the procedure while influencing their feelings, perception and behaviour (Al-Harasi 2010).

Short-term benefits of successful interventions include delivery of local anaesthetic and completion of dental treatment. This would occur at current or subsequent appointments or both, ultimately leading to restoration of oral health. The long-term benefit may involve reduction of dental anxiety, leading to acceptance of future treatment and development of positive attitudes towards oral health.

Why it is important to do this review

Local anaesthetic is still required for a number of procedures in paediatric dentistry. There is, however, no consensus on what is the best intervention to increase its acceptance.

Several authors looked at interventions for increasing children's acceptance to invasive medical treatment. One Cochrane systematic review looked at psychological interventions for needle-related procedural pain and distress in children and adolescents. This review focused on cognitive techniques, behavioural interventions and combined (cognitive-behavioural) interventions. The authors concluded that psychological interventions, especially distraction, hypnosis and combined cognitive-behavioural interventions, can be successful (Uman 2013). Similarly, another Cochrane review looking at interventions to assist induction of anaesthesia in children, studied psychological interventions, environmental interventions, equipment modification, social interventions and anaesthetic communication. The authors concluded that acupuncture, clown doctors, hypnosis, low sensory stimulation and hand held video games are likely to be helpful in reducing anxiety and improving cooperation (Yip 2009).

A number of studies and reviews have researched the effect of interventions to reduce pre-operative anxiety in adults. Bradt looked at music interventions and concluded that listening to music may have a beneficial effect on pre-operative anxiety (Bradt 2013). Adult studies interestingly include alternative therapies as acupuncture for reducing anxiety prior to dental treatment (Michalek-Sauberer 2012). This technique has been researched in children for reduction of gag reflex during impressions for orthodontic treatment, however, the authors are not aware of any published studies on its use for increasing acceptance of local anaesthetic (Sari 2010).

To our knowledge, there are no comprehensive systematic reviews on interventions to facilitate delivery of dental local anaesthetic in children. Although certain interventions have shown to be successful, controversy remains regarding a number of techniques, leading to confusion and empiric application in clinical settings.

Reviewing the available evidence will further our understanding of existing techniques, as well as determine whether further research on this topic is warranted.

Objectives

To evaluate the effects of methods for acceptance of local anaesthetic in children during dental treatment.

Methods

Criteria for considering studies for this review

Types of studies

We plan to include randomised controlled trials. We will exclude quasi-randomised trials and cross-over trials.

Types of participants

Children and adolescents aged up to 18 years old having dental treatment under local anaesthetic without general anaesthesia. Studies that include participants over the age of 18 will not be included in this review, to ensure our search is limited to children. If studies include both children and participants over 18 years old, they will be excluded, unless authors clearly provide separate data for both age groups. Children with disabilities or co-morbidities ('special needs' and medically compromised children) will be excluded from this review.

Types of interventions

Classification of interventions is complex and often overlapping, as there is no standard definition in the literature. We decided to adapt Meechan's factors for discomfort of local anaesthetic and include interventions based on studies referred to in our background.

Patient's factors will be excluded, as interventions will often require a multidisciplinary and lengthy approach which the remit will likely extend beyond that of acceptance of local anaesthetic.

Pharmacological techniques as oral, inhalation, intranasal and intravenous sedation or general anaesthetic have been subject of a number of trials and systematic reviews, including Cochrane reviews. For this reason, they will not be included in our search criteria. However, if sedation is administered to both study and control groups (hence not the researched intervention), these trials will be included in our review.

The studied intervention will, therefore, be classified as.

1. Equipment factors.

1.1 Audiovisual technology.

  • Visual.

  • Auditory.

  • Combined visual and auditory.

1.2 Topical anaesthetic.

  • Topical anaesthetic agents.

  • Cooling of injection site.

1.3 Local anaesthetic.

  • Gauge of needle.

  • Temperature of cartridge.

1.4 Electronic devices.

  • Infiltration devices.

  • Intraosseous devices.

  • Intraligamental devices.

1.5 Others.

  • Needleless devices.

  • Vibration device.

  • Transcutaneous nerve stimulation.

2. Dentist factors (non-pharmacological interventions).

2.1 Imagery suggestion.

2.2 Counter stimulation.

2.3 Systematic desensitisation.

2.4 Hypnosis.

2.5 Others.

  • Language - non-threatening words.

  • Viewing/hiding needle.

  • Time taken to deliver local anaesthetic.

  • Site of injection/order of treatment.

Test group

Any intervention used to increase acceptance of delivery of local anaesthetic. This review will not look at types, dosage or efficacy of local anaesthetic. Pharmacological behaviour management techniques such as sedation will be excluded as interventions.

Studies that combine two or more interventions (other than pharmacological) will be included and considered separately to single intervention trials.

Trials comparing two interventions by having more than one test group will be included in this review.

Control group

Delivery of local anaesthetic without the use of interventions assigned to the test group.

Types of outcome measures

Primary outcomes
  1. Acceptance of local anaesthetic (yes/no).

Secondary outcomes
  1. Completion of dental treatment (yes/no).

  2. Successful local anaesthetic/painless treatment (yes/no).

  3. Self or observational assessment of intraoperative distress/pain/acceptance of treatment during provision of local anaesthesia.

  4. Pain on injection (yes/no).

  5. Pre- and post-operative anxiety measures.

  6. Patient satisfaction: measured by questionnaires.

  7. Parent satisfaction: measured by questionnaires.

Assessment of children's pain and anxiety may be undertaken by one or more methods: physiological assessment (physical signs of anxiety: high pulse rate, release of stress hormones and dry mouth), questionnaires or interviews, anxiety scales (completed by parents or children) and behavioural assessment (direct observation of the child's behaviour or psychological state by researchers).

Important outcomes are acceptance of local anaesthetic, acceptance of treatment, pain on injection and intraoperative distress. These will be included in the summary of findings tables.

Adverse events related to specific interventions will be recorded where appropriate.

Search methods for identification of studies

Electronic searches

For the identification of studies included or considered for this review, we will develop detailed search strategies for each database searched. These will be based on the search strategy developed for MEDLINE (OVID) but revised appropriately for each database (Appendix 1). The search strategy will use a combination of controlled vocabulary and free text terms and will be linked with the Cochrane Highly Sensitive Search Strategy (CHSSS) for identifying randomised trials (RCTs) in MEDLINE: sensitivity maximising version (2008 revision) as referenced in Chapter 6.4.11.1 and detailed in box 6.4.c of the Cochrane Handbook for Systematic Reviews of Interventions, version 5.1.0 (updated March 2011) (Higgins 2011). The search of EMBASE will be linked to the Cochrane Oral Health Group filter for identifying RCTs.

We will search the following databases:

  • the Cochrane Oral Health Group's Trials Register (whole database)

  • the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, current issue)

  • MEDLINE via OVID (1946 to present)

  • EMBASE via OVID (1980 to present)

  • ISI Web of Knowledge (1945 to present).

No restrictions will be placed on the language or date of publication when searching the electronic databases. Non-English studies will be translated and included in the review.

Searching other resources

We will search the following databases for ongoing/unpublished trials:

Handsearching

Only handsearching done as part of the Cochrane Worldwide Handsearching Programme and uploaded to CENTRAL will be included (see the Cochrane Masterlist for details of journal issues searched to date).

Unpublished studies

We will contact specialists in the field for any unpublished data.

Data collection and analysis

Selection of studies

Two review authors will independently, and in duplicate, assess titles and abstracts and full text for inclusion in the review. We will select papers suitable for inclusion in this study using our selection criteria. Disagreement will be resolved by discussion. From this group, those studies which do not meet the inclusion criteria will be recorded in the excluded studies section of the review and the reason for exclusion will be noted in the 'Characteristics of excluded studies' table.

Data extraction and management

We will extract information relevant to the objectives and outcome measures into a specially designed data extraction form (Appendix 2). Any disagreements will be resolved by discussion. Journal or authors' names will not be masked before selection or extraction.

All studies meeting the selection criteria will be included regardless of quality. Descriptive data where available will be collected in addition to that already outlined. These data will be used to provide contextual information for the main outcomes thus aiding interpretation of results from this review.

Data to be collected include.

  • Year study started (if not available, year it was published).

  • Country where the study was carried out.

  • Type of intervention.

  • Who delivered the intervention.

  • Who delivered local anaesthetic.

  • Who assessed the intervention.

  • How the intervention was assessed.

  • Treatment provided.

  • Previous local anaesthetic for dental treatment.

  • Previous treatment of participants.

  • Setting of intervention/treatment.

  • Age of the child.

  • Gender of the child.

Assessment of risk of bias in included studies

All studies meeting the selection criteria will be included in this review regardless of quality.

Risk of bias will be assessed using the methodology set out in Chapter 8 of the Cochrane Handbook for Systematic Reviews of Interventions version 5.1.0 (Higgins 2011). Included trials will be assessed on the following domains.

  • Random sequence generation.

  • Allocation concealment.

  • Blinding of participants and personnel.

  • Incomplete outcome data.

  • Selective reporting.

  • Other sources of bias.

A description of these domains will be tabulated for each included trial, along with a judgement of low, high or unclear risk of bias.

A summary assessment of the risk of bias for the primary outcome (across domains) will be undertaken. Within a study, a summary assessment of low risk of bias will be given when there is a low risk of bias for all key domains, unclear risk of bias when there is an unclear risk of bias for one or more key domains, and high risk of bias when there is a high risk of bias for one or more key domains. Across studies, a summary assessment will be rated as low risk of bias when most information is from studies at low risk of bias, unclear risk of bias when most information is from studies at low or unclear risk of bias, and high risk of bias when the proportion of information is from studies at high risk of bias sufficient to affect the interpretation of the results.

Measures of treatment effect

For dichotomous outcomes such as acceptance of local anaesthetic we plan to calculate risk ratios along with 95% confidence intervals. Continuous outcomes such as intraoperative distress will be reported as mean and standard deviation in each group.

Unit of analysis issues

We plan that the approaches used will be outlined as described in the Cochrane Handbook for Systematic Reviews of Interventions 5.1.0 (Higgins 2011). Outcomes such acceptance of local anaesthetic, acceptance of treatment and anxiety will be analysed as the interventions were randomised. When more than one intervention is applied, they will be counted as combined interventions. We will adjust data derived from cluster-randomised controlled trials to allow for the clustered design.

Dealing with missing data

We plan that the approaches used will be outlined as described in the Cochrane Handbook for Systematic Reviews of Interventions 5.1.0 (Higgins 2011). We will analyse results where the necessary data are available. We will contact authors to obtain any relevant missing data or discuss data discrepancies. For trials which we cannot obtain missing data, we will use the available data from the trial report.

Assessment of heterogeneity

Heterogeneity in the results of the trials will be assessed where appropriate by inspection of a graphical display of the results and by formal tests of heterogeneity. Cochran's test for heterogeneity and the I2 statistic (which describes the percentage total variation across studies that is due to heterogeneity rather than chance) will be calculated for each meta-analysis in addition to the pooled fixed-effect estimate and its associated 95% confidence interval. We will use sensitivity analyses and meta-regression to explore, quantify and control for sources of heterogeneity between studies on those occasions where it is possible to do so. Such sources of heterogeneity may include, but will not be limited to participant characteristics and nature of the interventions.

We expect that studies will derive from participants' characteristics or heterogeneous groups of interventions, as psychological interventions will much differ from equipment-related interventions. However, when interventions share a common outcome, or outcomes, this will render it appropriate to combine data.

Assessment of reporting biases

We plan that this will be assessed,where appropriate, by inspection of funnel plots of the results and formal tests if possible.

Data synthesis

For dichotomous outcomes (e.g. acceptance of local anaesthetic), we will present the estimates of effect of the intervention used as risk ratios along with their associated 95% confidence intervals. For continuous outcomes, as assessment of distress or anxiety, we will use mean differences (or standardised mean differences if an outcome is measured using different scales) and their 95% confidence intervals.

We will attempt formal data synthesis in the form of meta-analysis for trials with similar outcome measures that are judged to have sufficiently similar experimental procedures and participants. We will combine risk ratios (for dichotomous data) and mean differences (for continuous data) using fixed-effect models (we will use random-effects models if more than three pooled trials). The use of a systemically delivered intervention means that there cannot be split-mouth trials. In the event that some trials do include paired data, we plan to combine these with the data from the parallel-group trials using the method of Elbourne et al (Elbourne 2002). We will use the approaches described by Follmann et al (Follmann 1992) to estimate the standard errors for those studies where the standard error is not explicitly reported, but it is appropriate to attempt to derive or estimate the standard error.

We plan to present data using summary of findings tables as described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011).

We plan to use illustrative means.

Subgroup analysis and investigation of heterogeneity

We propose the following subgroup analyses if data are available.

  1. Age: subdivided into three groups: under five, six to 11, 12 to 18 years old (as recommended by the British National Formulary when prescribing drugs to children).

  2. Gender.

  3. Site of local anaesthetic.

  4. Type of dental procedure.

  5. Pharmacological techniques: subdivided into two groups: pharmacological techniques (as sedation) used on both control and study groups; pharmacological techniques not employed.

The proposed subgroups were suggested as they may influence primary or secondary outcomes. Age and cognitive development may influence cooperation and type of intervention applied.

Although it is unclear whether gender will be determinant for acceptance of different types of interventions, it has been referred to in a number of studies as a possible influencing factor.

The type of dental procedure and site of injection may influence completion of treatment, as they may be considered more painful or anxiety inducing. Drilling and more invasive procedures have been considered the most anxiety-inducing treatments (Majstorovic 2004).

As previously discussed, pharmacological behaviour management techniques will be excluded as interventions. Sedation will, however, be included as a distinct subgroup if the same technique/agent is equally used on the control and test groups.

Sensitivity analysis

Sensitivity analysis is planned a priori to compare the study results for risk of bias.

Presentation of main results

A 'Summary of findings' table will be developed for important outcomes of this review using GRADEpro software. 

Important outcomes are acceptance of local anaesthetic, acceptance of treatment, pain on injection and intraoperative distress. These will be included in the summary of findings tables.

The quality of the body of evidence will be assessed with reference to the overall risk of bias of the included studies, the directness of the evidence, the inconsistency of the results, the precision of the estimates, the risk of publication bias, the magnitude of the effect and whether or not there is evidence of a dose response. The quality of the body of evidence for each of the primary outcomes will be categorised as high, moderate, low or very low.

Appendices

Appendix 1. MEDLINE (OVID) search strategy

  1. exp DENTISTRY/

  2. (dental$ or dentist$).ti,ab.

  3. (oral adj5 surg$).ti,ab.

  4. (orthodontic$ or pulpotom$ or pulpect$ or endodont$ or "pulp cap$").mp.

  5. ((dental or tooth or teeth or molar$ or incisor$ or cuspid$ or bicuspid$) adj5 (fill$ or restor$ or extract$ or remov$ or "cavity prep$" or caries or carious or decay$)).mp.

  6. (root canal and (therap$ or treat$)).mp.

  7. (tooth adj3 replant$).mp.

  8. or/1-7

  9. Anesthetics, Local/

  10. Anesthesia, Local/

  11. (local adj5 (anesthetic$ or anaesthetic$ or anesthesia or anaesthesia)).mp.

  12. Lidocaine/

  13. (lidocaine or lignocaine or xylocaine).mp.

  14. Carticaine/

  15. (carticain$ or articain$).mp.

  16. Prilocaine/

  17. (prilocain$ or citanest$ or propitocain$ or xylonest).mp.

  18. Bupivacaine/

  19. (bupivacain$ or buvacaina or carbostesin or dolanaest or marcain$ or sensorcain$ or svedocain$).mp.

  20. or/9-19

  21. exp Child/

  22. Infant/

  23. Adolescent/

  24. (child$ or infant$ or adolescen$ or teenage$ or preteen$ or pre-teen$).mp.

  25. (pediatric$ or paediatric$).mp.

  26. Dental care for children/

  27. or/21-26

  28. 8 and 20 and 27

Appendix 2. Data extraction form

Study ID  
First author  
Reviewer ID  
Year of publication  
Title (First 5 words)  
Country of study  

Please complete at end of data extraction:

Possible duplicate report: Yes/No

Author contact recommended: Yes/No

Verification of study eligibility/category

  Yes No
Children and adolescents up to 18 years old having dental treatment under local anaesthetic    
Primary outcome of review reported - acceptance of local anaesthetic    
Secondary outcome of review reported - completion of treatment  
Secondary outcome of review reported - assessment of intraoperative distress during provision of local anaesthetic  
Study designed as RCT    

Study eligible? Yes/No
(no to any of above renders study ineligible. Unclear renders study eligible until further clarified).

Comments:

Risk of bias assessment

 YesNoUnclear
Was a sample size calculation reported?   

Was method of generation of randomised sequence adequate?

(Yes = generated by random number table, tossed coin, and

shuffled cards)

(No = alternate assignment, hospital number and odd/even

DOB)

(Unclear = reference to randomisation but method not reported or inadequately explained)

   

Was allocation concealment adequate?

(Yes = central registrar, sequentially coded containers, sequentially coded opaque envelopes)

(No =randomisation not concealed (e.g. alternate assignment, hospital number, odd/even DOB) or not reported)

(Unclear = reference to allocation concealment but method not reported or inadequately explained)

   
Was the patient blinded to the therapy?   
Was the operator blinded to the therapy?   
Was the assessor blinded to the therapy?   
Were inclusion and exclusion criteria clearly defined in the text?   
Did the text state there were no withdrawals?   
Were outcomes of patients who withdrew or were excluded after allocation detailed separately?   
Were outcomes of patients who withdrew or were excluded after allocation included in an intention-to-treat analysis?   
Were treatment and control groups described at entry?   
Was the use of an intention-to-treat analysis stated?   

Study characteristics

Country where trial was conducted: ....................

Source of funding: Academic/Govt/Non-govt/Industry/Unclear

Year trial conducted: ........./Unclear

Number of centres in trial: .........../Unclear

Did the study report that ethical approval was obtained: Yes/No

Did the study report that informed consent was obtained: Yes/No

Population characteristics

Where were the participants recruited? Uni/Hosp/GDP practice/Paed speciality practice/Unclear

Dental treatment provided:

Previous dental treatment of patient: Yes/No/Unclear

Number of eligible participants  Number enrolled in study  
Number of males  Number of females  
Mean age (SD)  Age range  

Interventions

 InterventionNumber recruited at baselineNumber at the endReason for drop-outs given 
Control group    
Test 1    
Test 2    
Test 3    

Intervention delivered by:

Local anaesthetic delivered by:

Dental treatment delivered by:

Intervention assessed by:

Assessment method:

Outcomes

Primary outcome

InterventionIndex usedOutcome (describe nature of results)
Control   
Test 1   
Test 2   
Test 3   

Secondary/Other outcomes

InterventionIndex usedOutcome (describe nature of results)
Control   
Test 1   
Test 2   
Test 3   

Were there any other possible sources of bias?

...................................................................................................

Contributions of authors

Joana Monteiro (JM), Ajit Tanday (AT), Paul Ashley (PA): conceiving the review, designing the review, co-ordinating the review.

JM, AT and PA: undertaking searches, data collection and extraction for the review.

JM, AT: writing to authors of papers for additional information.

JM, AT: obtaining and screening data on unpublished studies, entering data into RevMan.

JM, AT, PA, Susan Parekh (SP), Aviva Petrie (AP): analysis of data, interpretation of data.

JM: writing the review.

Declarations of interest

Joana Monteiro, Ajit Tanday, Paul Ashley, Susan Parekh, Aviva Petrie: no interests to declare.

Sources of support

Internal sources

  • No sources of support supplied

External sources

  • National Institute for Health Research (NIHR), UK.

    CRG funding acknowledgement:
    The NIHR is the largest single funder of the Cochrane Oral Health Group.

    Disclaimer:
    The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the NIHR, NHS or the Department of Health.

  • Cochrane Oral Health Group Global Alliance, UK.

    All reviews in the Cochrane Oral Health Group are supported by Global Alliance member organisations (British Association of Oral Surgeons, UK; British Orthodontic Society, UK; British Society of Paediatric Dentistry, UK; British Society of Periodontology, UK; Canadian Dental Hygienists Association, Canada; National Center for Dental Hygiene Research & Practice, USA; Mayo Clinic, USA; New York University College of Dentistry, USA; and Royal College of Surgeons of Edinburgh, UK) providing funding for the editorial process (http://ohg.cochrane.org/).

Ancillary