Mark G Roback1, Joe E Wathen, Todd MacKenzie, Lalit Bajaj. 1. Department of Pediatrics, Section of Emergency Medicine, University of Colorado School of Medicine, The Children's Hospital, Denver, CO 80218, USA. Roback.Mark@tchden.org
Abstract
STUDY OBJECTIVE: We compare adverse events, efficacy, and length of sedation of intravenous (i.v.) versus intramuscular (i.m.) ketamine procedural sedation and analgesia for orthopedic procedures in the emergency department (ED). METHODS:Pediatric patients receivingketamine for orthopedic procedures were enrolled in a prospective, randomized, controlled trial in a children's hospital ED. All patients were initially randomized to receive ketamine either 1 mg/kg i.v. or 4 mg/kg i.m. Demographics, adverse events, sedation efficacy, and length of sedation were recorded. RESULTS:Two hundred twenty-five patients were randomized (116 i.v., 109 i.m.). Two hundred eight patients, aged 14 months to 15 years, completed the study, 109 i.v. and 99 i.m. Respiratory adverse events were similar between groups (i.v. 8.3% versus i.m. 4.0%; odds ratio [OR] 0.47; 95% confidence interval [CI] 0.14 to 1.6). Vomiting in the ED was more common in the i.m. group (26.3% versus 11.9%; OR 2.60; 95% CI 1.2 to 5.9). Using the Faces Pain Scale, patients in the i.m. group reported significantly less pain from the procedure. Video observers reported significantly lower distress in the i.m. group during the painful procedure (Observation Score of Behavioral Distress scores 0.35 i.m. versus 0.74 i.v.; mean difference 0.38; 95% CI 0.04 to 0.72). Length of sedation was significantly longer in the i.m. group (median 129 versus 80 minutes). Satisfaction of sedation was high in parents and physicians, with no difference in reported satisfaction between groups. This study was terminated early because of nursing resistance based on the longer recovery times observed in patients receiving ketamine i.m. CONCLUSION: In this study of pediatric sedation for orthopedic procedures, we found that ketamine 4 mg/kg i.m. was more effective than 1 mg/kg i.v. but demonstrated significantly longer recovery times and more vomiting.
RCT Entities:
STUDY OBJECTIVE: We compare adverse events, efficacy, and length of sedation of intravenous (i.v.) versus intramuscular (i.m.) ketamine procedural sedation and analgesia for orthopedic procedures in the emergency department (ED). METHODS: Pediatric patients receiving ketamine for orthopedic procedures were enrolled in a prospective, randomized, controlled trial in a children's hospital ED. All patients were initially randomized to receive ketamine either 1 mg/kg i.v. or 4 mg/kg i.m. Demographics, adverse events, sedation efficacy, and length of sedation were recorded. RESULTS: Two hundred twenty-five patients were randomized (116 i.v., 109 i.m.). Two hundred eight patients, aged 14 months to 15 years, completed the study, 109 i.v. and 99 i.m. Respiratory adverse events were similar between groups (i.v. 8.3% versus i.m. 4.0%; odds ratio [OR] 0.47; 95% confidence interval [CI] 0.14 to 1.6). Vomiting in the ED was more common in the i.m. group (26.3% versus 11.9%; OR 2.60; 95% CI 1.2 to 5.9). Using the Faces Pain Scale, patients in the i.m. group reported significantly less pain from the procedure. Video observers reported significantly lower distress in the i.m. group during the painful procedure (Observation Score of Behavioral Distress scores 0.35 i.m. versus 0.74 i.v.; mean difference 0.38; 95% CI 0.04 to 0.72). Length of sedation was significantly longer in the i.m. group (median 129 versus 80 minutes). Satisfaction of sedation was high in parents and physicians, with no difference in reported satisfaction between groups. This study was terminated early because of nursing resistance based on the longer recovery times observed in patients receiving ketamine i.m. CONCLUSION: In this study of pediatric sedation for orthopedic procedures, we found that ketamine 4 mg/kg i.m. was more effective than 1 mg/kg i.v. but demonstrated significantly longer recovery times and more vomiting.
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