Presented at the Society for Academic Emergency Medicine Annual Meeting, San Francisco, CA, May 2006. This project was funded by the makers of ondansetron. We approached GlaxoSmithKline (GSK) with the idea for the study, and they agreed to provide funding. GSK remained apart from all phases of the project: they did not approve the study design nor participate in data collection, analysis, writing the manuscript, or approval of the final manuscript. ClinicalTrials.gov Registration Identifier NCT 00429832.
Ondansetron versus Promethazine to Treat Acute Undifferentiated Nausea in the Emergency Department: A Randomized, Double-blind, Noninferiority Trial
Article first published online: 26 FEB 2008
© 2008 by the Society for Academic Emergency Medicine
Academic Emergency Medicine
Volume 15, Issue 3, pages 209–215, March 2008
How to Cite
Braude, D. and Crandall, C. (2008), Ondansetron versus Promethazine to Treat Acute Undifferentiated Nausea in the Emergency Department: A Randomized, Double-blind, Noninferiority Trial. Academic Emergency Medicine, 15: 209–215. doi: 10.1111/j.1553-2712.2008.00060.x
- Issue published online: 26 FEB 2008
- Article first published online: 26 FEB 2008
- Received July 24, 2007; revisions received October 19 and November 4, 2007; accepted December 5, 2007.
Objectives: The authors sought to compare ondansetron and promethazine among emergency department (ED) patients with undifferentiated nausea. The hypothesis was that ondansetron was not inferior to promethazine and that rates of adverse effects were similar.
Methods: This was a randomized double-blind noninferiority clinical trial conducted in an urban academic ED. A convenience sample of nonpregnant adults with at least 40 mm of self-reported nausea measured on a 100-mm visual analog scale (VAS) were enrolled. Patients who had already received more than 1 L of intravenous fluid or an antiemetic agent were excluded. Subjects were block-randomized in groups of 10 to either 4 mg of ondansetron or 25 mg of promethazine delivered intravenously. The primary outcome was change in nausea over 30 minutes. The authors used a 15-mm margin of noninferiority. Secondary endpoints included changes in anxiety, sedation, and other adverse effects. Analyses included t-tests, tests for proportions, and 95% confidence intervals (CIs).
Results: A total of 120 subjects completed the study, 60 in each arm. Baseline nausea, anxiety, and sedation scores were similar. Ondansetron and promethazine reduced nausea similarly (ondansetron −34 mm, promethazine −36 mm; difference −2 mm; 95% CI = −13 to 8 mm). The reduction in anxiety was similar (ondansetron −13 mm, promethazine −14 mm; difference −1 mm; 95% CI = −10 to 10 mm). Promethazine was associated with significantly more sedation than ondansetron (ondansetron 5 mm, promethazine 19 mm; difference 14 mm; 95% CI = 5 to 24 mm). There were no cases of akathisia in the ondansetron group and 2 cases in the promethazine group.
Conclusions: Promethazine and ondansetron have similar efficacy in reducing nausea among ED patients. Change in anxiety was similar, but promethazine was associated with greater sedation.