A comparison of oral ondansetron syrup or intravenous ondansetron loading dose regimens given in combination with dexamethasone for the prevention ofnausea 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 pat ients receiving moderately/highly emetogenic chemotherapy. On each day of c hemotherapy, patients were administered ondansetron 5 mg/m(2) IV and placeb o 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 adminis tered twice daily for 2 days following the cessation of chemotherapy. Compl ete 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 chemother apy 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 syru p ondansetron plus dexamethasone was well tolerated and effective in preven ting chemotherapy-indicated emesis in pediatric patients.