S A Shane1, S M Fuchs, H Khine. 1. Department of Pediatrics, Eastern Virginia Medical School, Children's Hospital of the King's Daughters, Norfolk.
Abstract
STUDY OBJECTIVE: To determine the efficacy of rectal midazolam as sedation for laceration repair in preschool children in the pediatric emergency department. DESIGN: Randomized, double-blind, placebo-controlled trial. PARTICIPANTS: Thirty-four anxious children aged 14 to 51 months with face or scalp lacerations 3 cm or less in length requiring two or more sutures and behavior scores of 3 or more. INTERVENTIONS: Subjects received 0.45 mg/kg rectal midazolam or saline placebo rectally followed by a topical anesthetic 15 minutes before repair. RESULTS: Sixteen patients received rectal midazolam, and 18 received placebo. The groups were similar in age, race, gender, laceration length and location, entry behavior score, and entry anxiety score. Ten patients in the rectal midazolam group and 1 in the placebo group achieved adequate sedation (P < .001). Median behavior scores during suturing were more favorable in the rectal midazolam group (P = .003 and P = .08, respectively). Two patients in the rectal midazolam group experienced inconsolable agitation after the repair. None of the patients suffered cardiopulmonary complications. CONCLUSION:Rectal midazolam is an effective method of sedation for facilitating uncomplicated laceration repair in preschool children. However, physicians must be aware of the possibility of paradoxical reactions when using midazolam in children.
RCT Entities:
STUDY OBJECTIVE: To determine the efficacy of rectal midazolam as sedation for laceration repair in preschool children in the pediatric emergency department. DESIGN: Randomized, double-blind, placebo-controlled trial. PARTICIPANTS: Thirty-four anxious children aged 14 to 51 months with face or scalp lacerations 3 cm or less in length requiring two or more sutures and behavior scores of 3 or more. INTERVENTIONS: Subjects received 0.45 mg/kg rectal midazolam or saline placebo rectally followed by a topical anesthetic 15 minutes before repair. RESULTS: Sixteen patients received rectal midazolam, and 18 received placebo. The groups were similar in age, race, gender, laceration length and location, entry behavior score, and entry anxiety score. Ten patients in the rectal midazolam group and 1 in the placebo group achieved adequate sedation (P < .001). Median behavior scores during suturing were more favorable in the rectal midazolam group (P = .003 and P = .08, respectively). Two patients in the rectal midazolam group experienced inconsolable agitation after the repair. None of the patients suffered cardiopulmonary complications. CONCLUSION: Rectal midazolam is an effective method of sedation for facilitating uncomplicated laceration repair in preschool children. However, physicians must be aware of the possibility of paradoxical reactions when using midazolam in children.