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Effect of intravenous ondansetron on QTc interval in children with gastroenteritis
Robert J Hoffman1, Khalid Alansari2
1Sidra Medical and Research Center, Department of Emergency Medicine, PO Box 26999, Doha, Qatar.
Insights
Ondansetron, a common anti-vomiting medication, did not prolong the QTc interval in children. This study found no significant QT prolongation in pediatric patients receiving ondansetron for gastroenteritis-associated vomiting.
Area of Science:
- Pediatric Emergency Medicine
- Clinical Pharmacology
- Cardiology
Background:
- Ondansetron is associated with QT prolongation and fatal dysrhythmias, as noted by the FDA.
- Limited clinical trials exist on ondansetron's cardiac effects in emergency departments, especially in pediatric populations.
Purpose of the Study:
- To assess the impact of a standardized intravenous ondansetron dose on QTc duration in children under 14 years.
- To investigate ondansetron's effect on pediatric QTc intervals in an emergency department setting, mirroring FDA thorough QT study protocols.
Main Methods:
- Electrocardiograms (ECGs) were recorded before and at intervals up to 60 minutes after administering 0.15mg/kg IV ondansetron.
- QT intervals were manually measured and corrected using Bazett's (QTcB) and Fridericia's (QTcF) formulas.
- Statistical analysis included paired t-tests and evaluation of categorical QT prolongation outcomes.
Main Results:
- 134 pediatric patients with gastroenteritis-associated vomiting were analyzed.
- The mean difference in QTc after ondansetron was minimal: 0.4msec for QTcB and 0.1msec for QTcF.
- No significant QTc prolongation exceeding established thresholds was observed.
Conclusions:
- A 0.15mg/kg dose of intravenous ondansetron did not prolong QTc intervals in pediatric patients.
- These findings suggest ondansetron is safe regarding QTc duration in children treated for vomiting in the ED.
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 administration, nor at later times.
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