• Joseph Miller, Stacey House, Luis Lovato, Andrew Meltzer, Barry Hahn, Jahn Avarello, Terry Plasse, Ira Kalfus, Reza Fathi, and Robert Silverman.
• Department of Emergency Medicine, Henry Ford Hospital and Wayne State University, Detroit, MI, United States. Electronic address: jmiller6@hfhs.org.
• Am J Emerg Med. 2021 May 1; 43: 205-209.

ObjectivesProspective data evaluating the effect of ondansetron on the corrected QT (QTc) interval is lacking in emergency department clinical use. As part of a randomized trial of a 24-mg bimodal-release ondansetron (RHB-102) pill, we tested the effect of RHB-102 compared to placebo on QTc change.MethodsThis was a planned safety outcome analysis within a multicenter, double-blind, placebo-controlled trial. The trial compared the effects of RHB-102 among patients ≥12 years who presented to 21 centers with symptoms of acute gastroenteritis. Patients with an initial baseline electrocardiogram as well as a follow-up electrocardiogram 4 h later were included in the analysis. The safety endpoint for this analysis was the change from baseline in QTc interval at 4 h, the median time at which ondansetron serum level peaks.ResultsA total of 147 patients were included with a mean baseline QTc in the RHB-102 and placebo arms of 410 and 406 ms, respectively. There was no difference in the change in QTc at 4 h post-study drug administration between the RHB-102 (+4, 95% CI 1-8 ms) and placebo group (+5, 95% CI 1-9 ms). In the RHB-102 arm, 6.6% of patients had a QTc change >30 ms and in the placebo arm 3.6% (p = 0.48). No patient in either arm had a QTc change >60 ms after study drug administration.ConclusionIn patients with normal baseline QTc, 24-mg bimodal-release ondansetron did not prolong the QTc in comparison to placebo.Copyright © 2020 Elsevier Inc. All rights reserved.

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