A COMPARISON OF ORAL ONDANSETRON SYRUP OR INTRAVENOUS ONDANSETRON LOADING DOSE REGIMENS GIVEN IN COMBINATION WITH DEXAMETHASONE FOR THE PREVENTION OF NAUSEA AND EMESIS IN PEDIATRIC AND ADOLESCENT PATIENTS RECEIVING MODERATELY/HIGHLY EMETOGENIC CHEMOTHERAPY

This double-blind, parallel-group, multicenter study compared the efficacy and safety of intravenous (IV) ondansetron with oral syrup ondansetron plus oral dexamethasone in the prevention of nausea and emesis in pediatric patients receiving moderately/highly emetogenic chemotherapy. On each day of chemotherapy, patients were administered ondansetron 5 mg/m(2) IV and placebo syrup orally (n = 215) or ondansetron 8 mg syrup orally and placebo IV (n = 223) plus dexamethasone 2-4 mg PO. Ondansetron 4 mg syrup PO was administered twice daily for 2 days following the cessation of chemotherapy. Complete or major control of emesis was obtained in 89% patients in the IV group and 88% patients in the oral syrup group during the worst day of chemotherapy treatment (90% CI: -6,4) and 85% and 82% patients, respectively, during the worst day of the study period (90% CI: -8,3). Intravenous or oral syrup ondansetron plus dexamethasone was well tolerated and effective in preventing chemotherapy-indicated emesis in pediatric patients.