NASAL VERSUS ORAL MIDAZOLAM FOR SEDATION OF ANXIOUS CHILDREN UNDERGOING LACERATION REPAIR

Study objective: To compare the efficacy and safety of a single dose o f midazolam, as an oral solution of 0.5 mg/kg, or nasal drops of 0.25 mg/kg, in children undergoing emergency department laceration repair. Design: Double-blind, double-placebo, randomized trial. Children under went standard would care when judged to demonstrate a reduction in anx iety following study medication. Participants: Fifty-eight patients be tween 1 and 10 years of age with uncomplicated lacerations judged to b e anxious by emergency physicians. Results: An anxiety score and vital signs were recorded at routine intervals. Groups were comparable with respect to age, laceration characteristics, initial vital signs, and anxiety scores. Both groups demonstrated reductions (mean +/- SD) in a nxiety scores over time (P < .05; maximum at 10 minutes; 1.2 +/- 0.9 m m for nasal and 0.8 +/- 1.3 for oral), with no significant differences between groups (repeat-measures ANOVA). Median observer-rated effecti veness using a visual analog scale (maximum effectiveness, 10 mm) was not significantly different between groups: nasal, 7.6 mm and oral, 6. 9 (Mann-Whitney U test: minimum detectable difference, 0.7, with alpha = 0.05 and beta = 0.2). Complications were judged to be minor only, a nd were more frequent in the nasal group (5 of 28, 4 with nasal burnin g) versus 1 of 26 in the oral group. Time from midazolam to ED dischar ge was not significantly different between groups: nasal, 54 +/- 15 mi nutes and oral, 57 +/- 16 minutes. Conclusion: A single dose of oral o r nasal midazolam results in reduced anxiety and few complications in selected children undergoing laceration repair in the ED. The oral rou te was associated with fewer administration problems.