An evaluation of the effectiveness and safety of midazolam in children undergoing dental surgery

Abstract

Objective: The aim of this study was to evaluate the effectiveness and safety of oral midazolam in children undergoing dental surgery. Materials and methods: A prospective, randomized, controlled trial was conducted to assess the effectiveness and safety of midazolam in children. Patients aged 2–9 years who underwent dental surgery under general anesthesia were randomly allocated into one of the four groups: midazolam 0.2 mg/kg dose group (n = 30); midazolam 0.21–0.4 mg/kg dose group (n = 15); midazolam more than 0.41 mg/kg dose group (n = 15) or the placebo group (n = 31). The effectiveness of midazolam on sedation was assessed by the evaluation of vital signs, such as the respiratory and heart rate, oxygen saturation and the patients’ reactive behaviors, in comparison with the placebo. Results: The scores of the ratings for sleep, movement and crying, as well as patients’ reactions at the moment of separation from their parents and their collaboration with the staff were statistically significantly better among patients who received oral midazolam compared with the placebo. There were statistically significant direct correlations between the doses of midazolam and higher sleep, movement, crying and reaction scores 30 min after premedication as well as higher scores of patients upon separation from their parents. There were only a few clinically insignificant side effects. Conclusions: Oral midazolam, at a single dose from 0.2 to 0.6 mg/kg, is effective and safe, and provides the expected sedative effects in children required by premedication for dental surgery