RANDOMIZED DOUBLE-BLIND CROSSOVER ONDANSETRON-DEXAMETHASONE VERSUS ONDANSETRON-PLACEBO STUDY FOR THE TREATMENT OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING IN PEDIATRIC-PATIENTS WITH MALIGNANCIES

Purpose: To determine whether the addition of dexamethasone to ondanse tron (OND + DEX) is a more effective antiemetic regimen than ondansetr on (OND) alone in children receiving chemotherapy. Patients and Method s: Children who had solid tumors and who were receiving highly emetoge nic chemotherapy, including cisplatin, carboplatin, cyclophosphamide, and ifosfamide, were randomized(1:1) in a double-blind fashion to rece ive either OND 0.15 mg/kg intravenously (i.v.) 30 min before and 4 and 8 h after chemotherapy and placebo, or OND + DEX (same OND doses plus DEX 8 mg/m(2) i.v. 30 min before chemotherapy, followed by 16 mg/m(2) in divided doses) as antiemetics. The patients were crossed over to t he other antiemetic regimen when receiving an identical course of chem otherapy. Patients were monitored for emetic episodes, nausea, appetit e, sense of well-being, and antiemetic adverse events. Results: A tota l of 33 patients were evaluated. Sixty-one percent of the patients rec eiving OND + DEX regimens had a complete response for emetic episodes as compared with 23% with OND alone. Combined complete and major respo nses two or less emetic episodes were 86% for OND + DEX and 67% for ON D. Failure for emetic episodes (more than five vomitings/day) were see n only in 7-10% of the total population. Minimal or no nausea was expe rienced in 74% of OND + DEX courses and in 52% of the OND courses. App etite was better in OND + DEX courses (p = 0.006). Both antiemetic arm s had similar adverse events. Mild to moderate sedation occurred in ab out half of the courses, followed by restlessness (29%), headache (17% ), diarrhea (17%), and hiccups (2%). Conclusion: The combination of on dansetron and dexamethasone is superior to ondansetron alone to contro l emetic episodes in children receiving highly emetogenic chemotherapy (p = 0.04).