Safety of oral midazolam sedation use in paediatric dentistry: A review

Abstract

Background: Little information is available as to the safety of midazolam when used as an oral sedative. Aim: To evaluate the side effects and other adverse outcomes following use of oral midazolam for behaviour management in paediatric dentistry. Design: A review of published literature relating to the safety and side effects of oral midazolam for use in paediatric dental procedures was conducted. Both randomised controlled trials and non-randomised studies were assessed. Reported side effects were recorded and classified as either significant or minor. The percentage prevalence of significant or minor side effects per episode of treatment was calculated. Results: Sixteen papers of randomised controlled trials met the inclusion criteria. None of the side effects recorded were considered as significant. Minor side effects were reported (n = 68, 14%), with nausea and vomiting being the most frequently recorded (n = 30, 6%). Eleven papers of non-randomised studies were included. No significant side effects were recorded. Minor side effects were recorded (n = 157, 8%), with paradoxical reaction being the most common at 3.8%. Conclusion: Significant side effects associated with oral midazolam usage for behaviour management in children and adolescents requiring dental treatment appear to be rare. Minor side effects are more common but determining precise figures is complicated by poor reporting. © 2012 John Wiley & Sons Ltd, BSPD and IAPD.