Weak evidence that oral midazolam is an effective sedative for children undergoing dental treatment

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Sadly,  despite the fact that dental caries is preventable and industrial nations have seen substantial falls in recent years there are still significance numbers of children with dental caries that remains untreated.   While many of these can be managed with routine care other need additional behavioural management support, sedation or for a small (but significant) minority general anaesthesia. The aim of this Cochrane review was to evaluate the efficacy and relative efficacy of conscious sedation agents and dosages for behaviour management in paediatric dentistry

Detailed 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  Reference lists from relevant articles were scanned and the authors contacted to identify trials and obtain additional information. There were no language restrictions.

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 were included with crossover trials being excluded

  • Thirty-six studies (2810 participants)  were included .
  • Thirty trials (83%) were at high risk of bias and six (17%) were at unclear risk of bias.
  • 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.

They found

  • Weak evidence from 5 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%). This 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.

The authors concluded that

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

Lourenço-Matharu L, Ashley PF, Furness S. Sedation of children undergoing dental treatment. Cochrane Database of Systematic Reviews 2012, Issue 3. Art. No.: CD003877. DOI: 10.1002/14651858.CD003877.pub4.


In a previous post we noted some two guidelines for sedation, one from NICE and the other from the Scottish Dental Clinical Effectiveness Programmme.

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Derek Richards

Derek Richards is a specialist in dental public health, Director of the Centre for Evidence-Based Dentistry and Specialist Advisor to the Scottish Dental Clinical Effectiveness Programme (SDCEP) Development Team. A former editor of the Evidence-Based Dentistry Journal and chief blogger for the Dental Elf website until December 2023. Derek has been involved with a wide range of evidence-based initiatives both nationally and internationally since 1994. Derek retired from the NHS in 2019 remaining as a part-time senior lecturer at Dundee Dental School until the end of 2023.

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