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

J Pediatr. 1995 Feb;126(2):309-13. doi: 10.1016/s0022-3476(95)70568-6.

Abstract

Purpose: 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.

Patients and 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.

Conclusion: Granisetron was superior to chlorpromazine-dexamethasone antiemetic therapy for children receiving ifosfamide therapy and deserves further study during other chemotherapy regimens.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Antiemetics / administration & dosage*
  • Antiemetics / adverse effects
  • Chi-Square Distribution
  • Child
  • Child, Preschool
  • Chlorpromazine / administration & dosage*
  • Chlorpromazine / adverse effects
  • Dexamethasone / administration & dosage*
  • Dexamethasone / adverse effects
  • Drug Therapy, Combination
  • Granisetron / administration & dosage*
  • Granisetron / adverse effects
  • Humans
  • Ifosfamide / adverse effects*
  • Infusions, Intravenous
  • Proportional Hazards Models
  • Prospective Studies
  • Safety
  • Single-Blind Method
  • Statistics, Nonparametric
  • Vomiting / chemically induced*
  • Vomiting / drug therapy*

Substances

  • Antiemetics
  • Dexamethasone
  • Chlorpromazine
  • Ifosfamide
  • Granisetron