Objective: To compare effectiveness and safety of standard care(SC) [comfort+topical anesthetic+injected lidocaine] vs. SC + three sedation regimens: 0.5 mg/kg oral midazolam (M), 50% nitrous oxide (N), or M+N (MN) in children 2-6 years of age requiring facial laceration suturing in the emergency department.

Design: Prospective, randomized clinical trial

Methods: Videotapes were blindly scored using the Observational Scale of Behavioral Distress (OSBD) to assess distress during baseline, PREParatory (wound cleaning, draping, and local anesthetics), SUTuring, RECovery, and suture removal (SR) intervals. After SUT, suturers rated satisfaction with sedation. Cardiorespiratory adverse effects (AE) were detected by monitoring vital signs and oximetry. Other AE were noted during SUT and by parent questionnaires completed 24 hours after SUT and 4-5 days later at SR. OSBD and questionnaire data were analyzed using ANOVA. AE data were analyzed using Fisher's Exact Test.

Results: 204 subjects were enrolled (MN=52, M=51, N=51, SC=50; mean age 4.1 years; 66% boys). Mean OSBD scores were lower for M, N, and MN compared to SC during wound cleaning (p=.0002), draping (p=.01), and injected lidocaine (p=.002). During SUT, mean OSBD scores were lower for N (p=.003) and MN (p=.02) compared to M; M was not different from SC (p=.5). Suturer satisfaction was higher for N (p=.01) and MN (p=.02) compared to SC. REC time was longer for M and MN compared to N and SC (p<.05). During SUT, cardiorespiratory AE did not occur, but vomiting occurred only in N (10%) and M (2%) (p=.02). By 24 hours, there were group differences (p's<.05) in AE for ataxia M/MN ≥ 30%, N/SC ≤ 3%; crying M/MN ≥ 11%, N/SC=0%; and sleeping more M=31%, MN/N/SC ≤ 13%. At 1 week, AE were rare. During SR, subjects were less likely to require restraint if they had previously been in N (p=.01) and MN (p=.04) groups compared to SC.

Conclusions: We conclude that for facial suturing in 2-6 year olds, regimens containing N were more effective in reducing distress, had fewer AE except vomiting and required less restraint at SR than midazolam or no sedation.