Effect of Oral Ondansetron on Vomiting Associated with Intramuscular Ketamine Sedation in Children: A Double-Blind, Randomized, Placebo-Controlled Trial

Abstract

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 ketamine 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.

Review article: Efficacy of prophylactic ondansetron versus placebo or control in reducing vomiting in children undergoing ketamine procedural sedation in the emergency department: A systematic review and meta‐analysis

“…All five RCTs addressed the question of vomiting in the ED post-PSA (n = 856). Four trials (n = 735) reported the incidence of vomiting post-discharge, three for up to 12 h 16,17,28 and one for up to 24 h. 15 One trial did not report vomiting postdischarge. 29 The age of participants was 4 years (mean) and ranged from 1 to 18 with a female-to-male ratio of 45.3% versus 54.7%.…”

“…One study was published in Korean. 16 All corresponding authors were contacted for clarification on missing information, such as the timing of prophylactic ondansetron and the use of adjunctive medications where relevant. None replied.…”

“…There was no difference in LOS 12 in five of the six intervention arms. [15][16][17]28 Parental satisfaction was only documented in two RCTs 16,28 with no difference. Time to resumption of normal diet was only documented in one RCT 15 and did not differ.…”

“…Five studies were at risk of bias because of missing outcome data. Four trials 15,16,28,29 had missing data of >10% between randomisation and analysis and one did not disclose exclusions or dropouts at any point of the recruitment or trial. 17 Two studies 17,29 deviated from intended interventions, for example, the medication being prepared, then likely administered, by a nurse in a way that is impossible to be blinded.…”

“…Other smaller trials have found even higher incidences ranging from 17.8% to 48% of PSA occurring either during the immediate recovery phase in ED or after discharge from ED. 7,8,[13][14][15][16][17] There is inconsistent reporting of coadministration of opioids throughout these trials. Route of administration and variable dosing could also be contributing factors to the variability.…”