A pilot study of the efficacy of oral midazolam for sedation in pediatric dental patients.

Oral midazolam is being used for conscious sedation in dentistry with little documentation assessing its efficacy. In order to accumulate preliminary data, a randomized, double-blind, controlled, crossover, multi-site pilot study was conducted. The objective was to determine if 0.6 mg/kg of oral midazolam was an equally effective or superior means of achieving conscious sedation in the uncooperative pediatric dental patient, compared with a commonly used agent, 50 mg/kg of oral chloral hydrate. Twenty-three children in three clinics who required dentistry with local anesthetic and were determined to exhibit behavior rated as "negative" or "definitely negative" based on the Frankl scale were assessed. They were evaluated with respect to acceptance of medication; initial level of anxiety at each appointment; level of sedation prior to and acceptance of local anesthetic; movement and crying during the procedure; and overall behavior. The results showed that the group randomly assigned to receive midazolam had a significantly greater initial level of anxiety for that appointment (P < 0.02), a finding that could clearly confound further determination of the efficacy of these drugs. Patients given oral midazolam had an increased level of sedation prior to the administration of local anesthetic compared with those given chloral hydrate (P < 0.015). No statistically significant differences were noted in any of the other parameters. The age of the patient was found to have no correlation with the difference in overall behavior (r = -0.09). These preliminary data warrant further clinical trials.

RCT Entities:   Population Interventions Outcomes