K Connors1, T E Terndrup. 1. Department of Emergency Medicine, State University of New York Health Science Center at Syracuse.
Abstract
STUDY OBJECTIVE: To compare the efficacy and safety of a single dose of 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 underwent standard wound care when judged to demonstrate a reduction in anxiety following study medication. PARTICIPANTS: Fifty-eight patients between 1 and 10 years of age with uncomplicated lacerations judged to be 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 anxiety scores over time (P < .05; maximum at 10 minutes; 1.2 +/- 0.9 mm for nasal and 0.8 +/- 1.3 for oral), with no significant differences between groups (repeat-measures ANOVA). Median observer-rated effectiveness 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, and were more frequent in the nasal group (5 of 28, 4 with nasal burning) versus 1 of 26 in the oral group. Time from midazolam to ED discharge was not significantly different between groups: nasal, 54 +/- 15 minutes and oral, 57 +/- 16 minutes. CONCLUSION: A single dose of oral or nasal midazolam results in reduced anxiety and few complications in selected children undergoing laceration repair in the ED. The oral route was associated with fewer administration problems.
RCT Entities:
STUDY OBJECTIVE: To compare the efficacy and safety of a single dose of 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 underwent standard wound care when judged to demonstrate a reduction in anxiety following study medication. PARTICIPANTS: Fifty-eight patients between 1 and 10 years of age with uncomplicated lacerations judged to be 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 anxiety scores over time (P < .05; maximum at 10 minutes; 1.2 +/- 0.9 mm for nasal and 0.8 +/- 1.3 for oral), with no significant differences between groups (repeat-measures ANOVA). Median observer-rated effectiveness 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, and were more frequent in the nasal group (5 of 28, 4 with nasal burning) versus 1 of 26 in the oral group. Time from midazolam to ED discharge was not significantly different between groups: nasal, 54 +/- 15 minutes and oral, 57 +/- 16 minutes. CONCLUSION: A single dose of oral or nasal midazolam results in reduced anxiety and few complications in selected children undergoing laceration repair in the ED. The oral route was associated with fewer administration problems.
Authors: Lenneke Schrier; Rob Zuiker; Frans W H M Merkus; Erica S Klaassen; Zheng Guan; Bert Tuk; Joop M A van Gerven; Ronald van der Geest; Geert Jan Groeneveld Journal: Br J Clin Pharmacol Date: 2016-12-20 Impact factor: 4.335