Ondansetron Safety Regarding Prolong QTc for Children with Head Trauma

Abstract

BackgroundThere have been recent reports of increased QT interval after head trauma in concussed athletes and adult patients. Ondansetron, which is widely used in treatment of nausea and vomiting symptoms in head injuries, was issued a safety warning from the U.S. Food and Drug Administration regarding QT prolongation and risk of fatal dysrhythmias. ObjectiveThe purpose of this study was to evaluate the safety of ondansetron regarding QT prolongation for patients experiencing nausea or vomiting after head trauma. MethodsPatients aged 1–20 years presenting to a pediatric emergency department with head trauma and who required a dose of ondansetron for nausea or vomiting were enrolled in the study. Patients received a baseline 12-lead electrocardiogram (ECG) prior to administration of either oral or IV ondansetron. A second post-ondansetron 12-lead ECG was performed after administration of ondansetron. All ECGs were reviewed and the QTc calculated manually by a board-certified pediatric cardiologist. ResultsForty-two patients met enrollment criteria. Five patients received IV ondansetron and 37 received oral ondansetron. Mean QTc pre ondansetron was 387.5 ms and mean QTc post ondansetron was 400.9 ms (p = 0.120). We found no statistically significant difference in other ECG parameters pre and post ondansetron. ConclusionsOndansetron is safe in regard to QTc prolongation in patients with head trauma. Based on this research, ondansetron should continue to be used for the treatment of nausea and vomiting in emergency department patients who present with head injury.