A randomized comparison of intravenously administered granisetron versus chlorpromazine plus dexamethasone in the prevention of ifosfamide-induced emesis in children.

Abstract

To compare the efficacy and safety of intravenously administered granisetron with those of chlorpromazine plus dexamethosone in the prevention of ifosmamide-induced emesis in children with malignant disease. Eighty-eight children, aged 2 to 17 years, were scheduled for ifosfamide therapy (> or = 3 gm/m2) for 2 or 3 consecutive days. On each day, children received granisetron, 20 microgram/kg intravenously, before ifosfamide therapy, plus up to two more doses within 24 hours if required, or chlorpromazine, 0.3 to 0.5 mg/kg intravenously, every 4 to 6 hours, plus dexamethasone, 2 mg/m2 intravenously every 8 hours. During the initial 24 hours, significantly fewer episodes of vomiting were recorded after granisetron administration (median number, 1.5 vs 7.0; p = 0.001), and the percentages of children having no more than one vomiting episode (51% granisetron vs 21% chlorpromazine-dexamethasone) and no worse than mild nausea (67% granisetron vs 38% chlorpromazine-dexamethasone) were lower after granisetron therapy (p < 0.01). Fewer children had sedation with granisetron (2 vs 19; p < 0.001); there were no extrapyramidal reactions during granisetron therapy compared with two during control therapy. Granisetron was superior to chlorpromazine-dexamethasone antiemetic therapy for children receiving ifosfamide therapy and deserves further study during other chemotherapy regimens.