Effect of submucosal midazolam on behavior and physiologic response when combined with oral chloral hydrate and nitrous oxide sedation.

PURPOSE This study was designed to examine the efficacy and safety of submucosal (SM) midazolam and oral chloral hydrate (CH) when used for pediatric conscious sedation in a clinical dental environment. METHODS Twenty children ages 32 to 63 months participated in this institutionally approved study. Selection criteria included good health (ASA I), 2 to 5 years of age, uncooperative behavior, and the need for multiple restorative visits. In a double-blind crossover design, patients were randomly assigned to receive either oral CH (50 mg/kg) and SM midazolam (0.2 mg/kg), or oral CH (50 mg/kg) and SM saline placebo on their first sedation visit. On the second sedation visit, the patient received the opposite drug regimen than the first visit. Nitrous oxide (50%) was used during each sedation visit. Behavior response was rated as quiet (Q), crying (C), movement (M), or struggling (S) every 2.5 minutes through 40 minutes of operative procedures. Sedations were monitored using a capnograph, pulse oximeter, an automated blood pressure cuff, and precordial stethoscope. Respiratory rate (RR), heart rate (HR), and blood pressure (BP) were evaluated for each procedure. Data was analyzed using ANOVA and multinomial repeated-measures logistic regression. RESULTS Analysis showed a significant difference in behavior during sedation across drug regimen (chi-square = 55.6, df = 3, P < .0001). Patients given SM midazolam in addition to oral CH showed increased Q rating and decreased C, M, and S ratings. RR, BP, and HR for both groups remained within the normal values for 2- to 5-year-olds. CONCLUSIONS SM midazolam improved the quality of sedation without compromising safety. Quiet behavior was increased and struggling behavior was decreased. In addition, mean HR, RR, and BP analysis did not deviate from the norm for this age group.