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Abstract
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 on dansetron 5 mg/m2 IV and placebo syrup orally ( n = 215) orondansetron 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 in 85% and 82% patients, respectively, during the worst day of the study period (90% CI: 8, 3). Intravenous ororal syrup ondansetron plus dexamethasone was well tolerated and effective in preventing chemotherapy-induced emesis in pediatric patients.