A Comparison of Oral Ondansetron Syrup or Intravenous Ondansetron Loading Dose Regimens Given in Combination With Dexamethasone for the Prevention of Nausea and Emesis in Pediatric and Adolescent Patients Receiving Moderately/Highly Emetogenic Chemotherapy

Abstract

This double-blind, parallel-group, multicenter study compared the efficacy and safety of intravenous (i.v.) ondansetron with oral syrup ondansetron plus oral dexamethasone in the prevention of nausea and emesis in pediatric patients receiving moderately/highly emetogenic chemotherapy. On each day of chemotherapy, patients were administered ondansetron 5 mg/m2 i.v. and placebo syrup orally (n = 215) or ondansetron 8 mg syrup orally and placebo i.v. (n = 223) plus dexamethasone 2-4 mg p.o. Ondansetron 4 mg syrup p.o. was administered twice daily for 2 days following the cessation of chemotherapy. Complete or major control of emesis was obtained in 89% patients in the i.v. group and 88% patients in the oral syrup group during the worst day of chemotherapy treatment (90% CI: -6, 4) and in 85% and 82% patients, respectively, during the worst day of the study period (90% CI: -8, 3). Intravenous or oral syrup ondansetron plus dexamethasone was well tolerated and effective in preventing chemotherapy-induced emesis in pediatric patients.

Guideline for the prevention of acute nausea and vomiting due to antineoplastic medication in pediatric cancer patients

“…The panel's recommendation regarding the dexamethasone dose to be given to children receiving MEC stems from the observations of White et al [19]. Given the highly variable dexamethasone clearance in children [40] and the lack of specific information regarding bioavailability of dexamethasone in children, it is reasonable to recommend the same dose IV in cases where the oral route of administration is not appropriate.…”

“…No other study has evaluated the combination of dexamethasone plus a 5-HT3 antagonist in children receiving MEC. The other two studies identified compared dexamethasone doses ranging from 6 to 10 mg/m 2 /day combined with either chlorpromazine or metoclopramide [19,34].…”

“…White et al [19] evaluated the efficacy of dexamethasone plus either oral or IV ondansetron in an RCT in 428 children about to receive what the authors described as MEC or HEC. On the first day of the antineoplastic block, complete control of vomiting and retching was achieved in 78-81% of children whereas control of nausea was achieved in 70-73%.…”

“…Three studies were identified in which chemotherapy was classified as MEC using the POGO guideline [5] or as deemed by the investigators [19,34,39]. All were randomized comparisons of varying antiemetic regimens, in which at least one arm included dexamethasone.…”

“…All were randomized comparisons of varying antiemetic regimens, in which at least one arm included dexamethasone. A single RCT evaluated AINV control provided by dexamethasone plus either oral or IV ondansetron in children receiving MEC or HEC [19]. Dexamethasone was given by mouth in a dose based on body surface area ( 0.6 m 2 : 2 mg BID; >0.6 m 2 : 4 mg BID).…”