Objectives: To assess the safety, effectiveness and acceptability of o:ral midazolam sedation for orthodontic extraction of permanent teeth in children.
Design: A prospective, randomised, controlled, crossover trial.
Methods: A total of 26 children aged 10-16 (ASA I), referred for orthodontic extraction of premolar or canine teeth under sedation, were included in the study. Each child required two treatment sessions for the extraction of equivalent teeth on opposite sides of the mouth. Each subject was sedated with either ora midazolam (0.5 mg/kg) or nitrous oxide and oxygen (30%/70%) at the first visit and the alternative form at the second visit. At each visit two teeth were extracted, one upper and one lower. Heart rate, arterial oxygen saturation, respiration rate, sedation and behavioural scores were recorded every five minutes. Overall behaviour, patient acceptance and patient satisfaction were recorded at the end of treatment.
Results: Of the 26 children included in the study there were 12 males and 14 females. The mean age was 12.5 years. The mean heart rate and respiratory rate for both groups were similar and within acceptable clinical limits. The lowest mean arterial oxygen saturation levels for nitrous oxide and midazolam sedation were 97.7% and 95.0% respectively. Although midazolam caused greater oxygen desaturation, the range (91%-100%) was within safe limits for conscious sedation. The mean level of sedation was greater in the midazolam group compared with the nitrous oxide group and all but one case completed treatment. A total of 23 patients (88%) said they would be prepared to have ora midazolam sedation again and 17 (65%) actually preferred oral midazolam to nitrous oxide sedation.
Conclusion: Oral midazolam (0.5mg/kg) appears to be a safe and acceptable form of sedation for 10-16 year old paediatric dental patients.