Review question
The aim of this Cochrane Review was to find out which drugs used to sedate children during dental treatment were the most effective.
Background
Fear of the dentist may be expressed as unco-operative behaviour in children requiring dental treatment. Behaviour management problems can result in a child's tooth decay going untreated. While behavioural techniques play an important role in managing children, some children still find it difficult to co-operate with dental treatment and may require sedation. This review examined the effects of drugs to sedate a child whilst keeping them conscious.
Study characteristics
Authors from Cochrane Oral Health carried out this review and the evidence is up to date to 22 February 2018. A total of 50 randomised controlled trials were included with a total of 3704 participants. Within these studies 34 different sedatives were used, often with inhalational nitrous oxide as well. Dosages and delivery of these drugs varied widely. We grouped studies into those where drugs were compared to a placebo, where drugs were compared to other drugs or where different dosages of drugs were compared. Because all the studies were so different we could only carry out a meta-analysis for studies comparing oral midazolam to a placebo. The review showed that use of oral midazolam made patients more co-operative for dental treatment than a placebo drug. Where reported, adverse effects were few and minor.
Key results
Oral midazolam probably improves behaviour of children during dental treatment. We evaluated other sedatives but there is insufficient evidence to draw any conclusions.
Certainty of the evidence
There is some moderate-certainty evidence that midazolam administered in a drink of juice is effective.
There is some moderate-certainty evidence that oral midazolam is an effective sedative agent for children undergoing dental treatment. 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.
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. This is the second update of the Cochrane Review first published in 2005 and previously updated in 2012.
To evaluate the efficacy and relative efficacy of conscious sedation agents and dosages for behaviour management in paediatric dentistry.
Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 22 February 2018); the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 1) in the Cochrane Library (searched 22 February 2018); MEDLINE Ovid (1946 to 22 February 2018); and Embase Ovid (1980 to 22 February 2018). The US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials. No restrictions were placed on the language or date of publication when searching the electronic databases.
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. We excluded cross-over trials.
Two review authors independently extracted, in duplicate, information regarding methods, participants, interventions, outcome measures and results. Where information in trial reports was unclear or incomplete authors of trials were contacted. Trials were assessed for risk of bias. Cochrane statistical guidelines were followed.
We included 50 studies with a total of 3704 participants. Forty studies (81%) were at high risk of bias, nine (18%) were at unclear risk of bias, with just one assessed as at low risk of bias. There were 34 different sedatives used with or without inhalational nitrous oxide. Dosages, mode of administration and time of administration varied widely. Studies were grouped into placebo-controlled, dosage and head-to-head comparisons. Meta-analysis of the available data for the primary outcome (behaviour) was possible for studies investigating oral midazolam versus placebo only. There is moderate-certainty evidence from six small clinically heterogeneous studies at high or unclear risk of bias, that the use of oral midazolam in doses between 0.25 mg/kg to 1 mg/kg is associated with more co-operative behaviour compared to placebo; standardized mean difference (SMD) favoured midazolam (SMD 1.96, 95% confidence interval (CI) 1.59 to 2.33, P < 0.0001, I2 = 90%; 6 studies; 202 participants). It was not possible to draw conclusions regarding the secondary outcomes due to inconsistent or inadequate reporting or both.