Sedation of children undergoing dental treatment.

BACKGROUND: Children's fear about dental treatment may lead to behaviour management problems for the dentist, which can be a barrier to the successful dental treatment of children. Sedation can be used to relieve anxiety and manage behaviour in children undergoing dental treatment. There is a need to determine from published research which agents, dosages and regimens are effective.

OBJECTIVES: To evaluate the efficacy and relative efficacy of conscious sedation agents and dosages for behaviour management in paediatric dentistry.

SEARCH METHODS: Electronic searches of MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Dissertation Abstracts, SIGLE, the World Wide Web (Google) and the Community of Science Database were conducted for relevant trials and references up to 4th August 2011. Reference lists from relevant articles were scanned and the authors contacted to identify trials and obtain additional information. There were no language restrictions. Trials pre-1966 were not searched.

SELECTION CRITERIA: Studies were selected if they met the following criteria: randomised controlled trials of conscious sedation comparing two or more drugs/techniques/placebo undertaken by the dentist or one of the dental team in children up to 16 years of age. Crossover trials were excluded.

DATA COLLECTION AND ANALYSIS: Information regarding methods, participants, interventions, outcome measures and results were independently extracted, in duplicate, by two review authors. Where information in trial reports was unclear or incomplete authors of trials were contacted. Trials were assessed for risk of bias. The Cochrane Collaboration statistical guidelines were followed.

MAIN RESULTS: Thirty-six studies were included with a total of 2810 participants. Thirty trials (83%) were at high risk of bias and six (17%) were at unclear risk of bias. There were 28 different sedatives used with or without inhalational nitrous oxide. Dosages, mode of administration and time of administration varied widely. Trials were grouped into placebo-controlled, dosage and head-to-head comparisons. Meta-analysis of the available data was possible for studies investigating oral midazolam vs placebo only. There is weak evidence from five small clinically heterogeneous trials at high risk of bias, that the use of oral midazolam in doses between 0.25 mg/kg to 0.75 mg/kg is associated with more co-operative behaviour compared to placebo; standardised mean difference (SMD) favoured midazolam (SMD 2.98, 95% confidence interval (CI) 1.58 to 4.37, P < 0.001, I² = 91%), which translates to an increase of approximately 1.8 points on the six-point Houpt behaviour scale. There is very weak evidence from two trials which could not be pooled that inhalational nitrous oxide is more effective than placebo.

AUTHORS' CONCLUSIONS: There is some weak evidence that oral midazolam is an effective sedative agent for children undergoing dental treatment. There is very weak evidence that nitrous oxide inhalation may also be effective. There is a need for further well designed and well reported clinical trials to evaluate other potential sedation agents. Further recommendations for future research are described and it is suggested that future trials evaluate experimental regimens in comparison with oral midazolam or inhaled nitrous oxide.