Randomized, controlled, cross-over clinical trial comparing intravenous midazolam sedation with nitrous oxide sedation in children undergoing dental extractions

Abstract

Background. The use of benzodiazepines for paediatric dental sedation has received limited attention with regard to research into clinical effectiveness. A study was therefore designed to investigate the use of midazolam, for i.v. sedation in paediatric dental patients.

Method. The aim of the study was to assess the effectiveness of i.v. midazolam in a randomized, controlled, cross‐over trial. Children aged 12–16 yr (ASA I and II), requiring two appointments for equivalent but contralateral dental extractions for orthodontic purposes, were recruited. Conscious sedation with either i.v. midazolam titrated at 0.5 mg min–1, to a maximum of 5 mg, or nitrous oxide/oxygen titrated to 30%/70% inhalation sedation was used at the first visit, the alternative being used at the second visit. Vital signs including blood pressure, arterial oxygen saturation and ventilatory frequency, as well as sedation levels and behavioural scores, were recorded every 2 min.

Results. Forty patients, mean age 13.2 yr (range 12–16 yr), participated in the trial. A mean dose of midazolam 2.8 mg was administered in the test group. The median time to the maximum level of sedation was 8 min for midazolam compared with 6 min for nitrous oxide (P<0.001). Vital signs for both treatments were comparable and within acceptable clinical limits and communication with the patient was maintained at all times. The median (range) lowest arterial oxygen saturation level recorded for midazolam was 97 (91–99)% compared with 97 (92–100)% for nitrous oxide. The mean (range) recovery time for midazolam was 51.6 (39–65) min and 23.3 (20–34) min for nitrous oxide (P<0.0001). Fifty‐one per cent said they preferred i.v. midazolam, 38% preferred nitrous oxide, and 11% had no preference.

Conclusion. I.V. midazolam sedation (0.5 mg min–1 to a maximum of 5 mg) appears to be as effective as nitrous oxide sedation in 12–16‐yr‐old healthy paediatric dental patients.