Purpose: The purpose of this study is to investigate the effect of oral ondansetron on the incidence of vomiting in children who receive intramuscular (IM) ketamine for procedural sedation and analgesia in the emergency department (ED). Methods: In this double-blind, randomized, placebo-controlled trial in a children's hospital ED, patients receiving IM ketamine (5 mg/kg) for ED procedures were randomized to receive either oral ondansetron (2 mg or 4 mg) or placebo 15 minutes before the

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... injection. We recorded whether vomiting occurred in the ED postsedation or up to 12 hours after discharge with telephone follow-up and compared ED length of stay and parental satisfaction. Results: Thirty two children were randomized to placebo and 31 to ondansetron. The groups were similar in age, sex, and fasting duration. ED vomiting was no significant difference with ondansetron: 7 of 31 (22.6%) versus 6 of 32 (18.8%), P=0.707, difference -3.8 (95% confidence interval -23.8% to 16.2%). Follow-up completed in 82.5%. The vomiting in the ED or after discharge in two groups, there was no significant difference: 7 of 27 (25.9%) versus 12 of 25 (48.0%), P=0.165, difference 22.1% (95% confidence interval -3.5% to 47.7%). ED length of stay and parental satisfaction were similar between groups. Conclusion: There is no significant reduction of the incidence of vomiting in oral ondansetron group with IM ketamine procedural sedation in children.