Efficacy and safety of midazolam for sedation in pediatric dentistry: a controlled clinical trial.

PURPOSE: Pharmacological management of uncooperative children is becoming increasingly common in the dental setting. The purpose of this study was to determine the efficacy and safety of 3 different doses of midazolam for sedation in 2- to 4- year-old children with multiple dental needs and negative behavior. METHODS: Ten children participated in this crossover, controlled, double-blinded clinical trial, which evaluated their behavior, appointment length and patient response after administration of 3 different doses of midazolam or placebo. Oxygen saturation, heart rate, respiratory rate, and blood pressure were monitored in all sessions. RESULTS: Sedated children exhibited a more positive behavior compared to the placebo group, both at the beginning of the appointment (sitting in the chair) and during administration of local anesthesia (P=.008 and P<.03, respectively). The use of midazolam allowed for longer appointments, and doses of at least 0.3 mg/kg produced a higher rate of positive behavior overall. No changes in oxygen saturation, heart rate, respiratory rate, and blood pressure were observed. CONCLUSION: Midazolam was effective and safe for pediatric sedation in the dosages studied.