Effect of intravenous ondansetron on QTc interval in children with gastroenteritis
Abstract
BACKGROUND: The potential for ondansetron to cause QT prolongation and fatal dysrhythmia is well-reported, including a 2011 FDA report on the topic. Few clinical trials evaluating this phenomenon in the ED setting exist, and only one is pediatric.
OBJECTIVE: We have sought to determine the effect of a standardized dose of intravenous ondansetron on the QTc duration of children under 14years of age treated for gastroenteritis-associated vomiting in a pediatric ED. This study is modeled closely after an FDA "thorough QT study".
METHODS: EGCs were obtained before and 15, 30, 45, and 60min after a 0.15mg/kg IV dose of ondansetron given for gastroenteritis-associated vomiting. QT intervals were measured manually with digital calipers, and the QTc interval calculated both by Bazett's (QTcB) and Fridericia's (QTcF) correction. A paired t-test comparing QTc was conducted, and frequency of categorical outcomes of prolongation>30msec, >60 msec, and absolute prolongation >450 msec, >480 msec, and >500msec were evaluated.
RESULTS: In a 4-month period, 134 patients were included in the study, 46% were male. The average QTc prior to ondansetron administration was: QTcB 415 msec (95% CI 343-565) and QTcF 373 (95% CI 304-499). The mean difference in QTc after ondansetron was 0.4msec for QTcB (95% CI -35-45msec) and 0.1msec for QTcF (95% CI -40-18msec).
CONCLUSION: In these children, 0.15mg/kg of intravenous ondansetron did not cause prolongation of QTcB or QTcF measured 15min after…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 134 participants or records.
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