A randomised, controlled, crossover trial of oral midazolam and nitrous oxide for paediatric dental sedation

Abstract

A randomised, controlled, crossover trial was designed to assess the safety and effectiveness of oral midazolam sedation for orthodontic extractions. Forty-six ASA physical status I children aged 10-16 years were recruited. Each child required two treatment sessions. Sedation with either oral midazolam 0.5 mg.kg-1 or nitrous oxide in oxygen was used at the first visit, the alternative being used at the second visit. Blood pressure, heart rate, arterial oxygen saturation, and sedation and behavioural scores were recorded every 5 min. Anxiety levels and postoperative satisfaction were also recorded. Blood pressure, heart rate and arterial oxygen saturation in both groups were similar and within acceptable clinical limits. The median [range] lowest arterial oxygen saturation levels for subjects in the midazolam and nitrous oxide groups were 95 [90-100]% and 98 [93-100]%, respectively. The median [range] time to the maximum level of sedation in the midazolam group was 20 [5-65] min compared with 5 [5-10] min in the nitrous oxide group (p < 0.001). The median [range] duration of treatment was similar in both groups (midazolam group: 10 [5-30] min, nitrous oxide group: 10 [5-25] min). Seventy-four per cent of subjects were prepared to have oral midazolam sedation again, 54% preferring it. Oral midazolam appears to be a safe and acceptable form of sedation for 10-16-year-old paediatric dental patients.