OBJECTIVES: To compare the effects of droperidol and ondansetron on electrocardiographic indices of myocardial repolarization in children. AIM: To refine understanding of the torsadogenic risk to children exposed to anti-emetic prophylaxis in the perioperative period. BACKGROUND:QT interval prolongation is associated with torsades des pointes (TdP), but is a poor predictor of drug torsadogenicity. Susceptibility to TdP arises from increased transmural dispersion of repolarization (TDR) across the myocardial wall, rather than QT interval prolongation per se. TDR can be measured on the electrocardiogram as the time interval between the peak and end of the T wave (Tp-e). Tp-e may therefore provide a readily available, noninvasive assay of drug torsadogenicity. The perioperative period is one of high risk for TdP in children with or at risk of long QT syndromes. Droperidol and ondansetron are two drugs commonly administered perioperatively, for prophylaxis of nausea and vomiting, which can prolong the QT interval. This study investigated their effects on myocardial repolarization. METHODS:One hundred and eight ASA1-2 children undergoing elective day-case surgery were randomized to receive droperidol, ondansetron, both or neither. Pre- and post-administration 12-lead electrocardiogram (ECGs) were recorded. QT and Tp-e intervals were measured and compared within and between groups, for the primary endpoint of a 25 ms change in Tp-e. RESULTS:Eighty children completed the study. There were no demographic or baseline ECG differences between groups. QT intervals lengthened by 10-17 ms after allocated treatments, with no between-group differences. Values remained within normal limits for all groups. Tp-e intervals increased by 0-7 ms, with no between-group differences. There were no instances of dysrhythmia. CONCLUSIONS:Droperidol and ondansetron, in therapeutic anti-emetic doses, produce equivalent, clinically insignificant QT prolongation and negligible Tp-e prolongation, suggesting that neither is torsadogenic in healthy children at these doses.
RCT Entities:
OBJECTIVES: To compare the effects of droperidol and ondansetron on electrocardiographic indices of myocardial repolarization in children. AIM: To refine understanding of the torsadogenic risk to children exposed to anti-emetic prophylaxis in the perioperative period. BACKGROUND:QT interval prolongation is associated with torsades des pointes (TdP), but is a poor predictor of drug torsadogenicity. Susceptibility to TdP arises from increased transmural dispersion of repolarization (TDR) across the myocardial wall, rather than QT interval prolongation per se. TDR can be measured on the electrocardiogram as the time interval between the peak and end of the T wave (Tp-e). Tp-e may therefore provide a readily available, noninvasive assay of drug torsadogenicity. The perioperative period is one of high risk for TdP in children with or at risk of long QT syndromes. Droperidol and ondansetron are two drugs commonly administered perioperatively, for prophylaxis of nausea and vomiting, which can prolong the QT interval. This study investigated their effects on myocardial repolarization. METHODS: One hundred and eight ASA1-2 children undergoing elective day-case surgery were randomized to receive droperidol, ondansetron, both or neither. Pre- and post-administration 12-lead electrocardiogram (ECGs) were recorded. QT and Tp-e intervals were measured and compared within and between groups, for the primary endpoint of a 25 ms change in Tp-e. RESULTS: Eighty children completed the study. There were no demographic or baseline ECG differences between groups. QT intervals lengthened by 10-17 ms after allocated treatments, with no between-group differences. Values remained within normal limits for all groups. Tp-e intervals increased by 0-7 ms, with no between-group differences. There were no instances of dysrhythmia. CONCLUSIONS:Droperidol and ondansetron, in therapeutic anti-emetic doses, produce equivalent, clinically insignificant QT prolongation and negligible Tp-e prolongation, suggesting that neither is torsadogenic in healthy children at these doses.
Authors: Andrea C Tricco; Charlene Soobiah; Erik Blondal; Areti A Veroniki; Paul A Khan; Afshin Vafaei; John Ivory; Lisa Strifler; Huda Ashoor; Heather MacDonald; Emily Reynen; Reid Robson; Joanne Ho; Carmen Ng; Jesmin Antony; Kelly Mrklas; Brian Hutton; Brenda R Hemmelgarn; David Moher; Sharon E Straus Journal: BMC Med Date: 2015-06-18 Impact factor: 8.775