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


METHODS
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.


RESULTS
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.


CONCLUSIONS
Granisetron was superior to chlorpromazine-dexamethasone antiemetic therapy for children receiving ifosfamide therapy and deserves further study during other chemotherapy regimens.
Department of Pediatrics, Sophia Children's Hospital, Rotterdam, The Netherlands.
K
K
Hählen
E
E
Quintana
C R
CR
Pinkerton
E
E
Cedar
D000293:Adolescent; D000932:Antiemetics / Q000008:administration & dosage* / Q000009:adverse effects; D016009:Chi-Square Distribution; D002648:Child; D002675:Child, Preschool; D002746:Chlorpromazine / Q000008:administration & dosage* / Q000009:adverse effects; D003907:Dexamethasone / Q000008:administration & dosage* / Q000009:adverse effects; D004359:Drug Therapy, Combination; D017829:Granisetron / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007069:Ifosfamide / Q000009:adverse effects*; D007262:Infusions, Intravenous; D016016:Proportional Hazards Models; D011446:Prospective Studies; D012449:Safety; D016037:Single-Blind Method; D018709:Statistics, Nonparametric; D014839:Vomiting / Q000139:chemically induced* / Q000188:drug therapy*
D000932:Antiemetics; D002746:Chlorpromazine; D003907:Dexamethasone; D017829:Granisetron; D007069:Ifosfamide