Single daily dosing versus divided dosing intravenous ondansetron to prevent chemotherapy-induced nausea and vomiting among children: A comparative randomized double-blind controlled trial

Pediatr Blood Cancer. 2021 Jun;68(6):e29002. doi: 10.1002/pbc.29002. Epub 2021 Mar 23.

Abstract

Background: Chemotherapy-induced nausea and vomiting (CINV) is a common complication in cancer treatment. Ondansetron is an effective antiemetic drug widely used to prevent CINV; however, the effective administrative dosing strategies among pediatrics remain unclear. The study aimed to investigate clinical effectiveness of single daily dosing versus divided dosing ondansetron.

Methods: In all, 194 children undergoing chemotherapy were randomized to receive either single daily dosing (0.3 mg/kg/dose) or divided dosing (0.15 mg/kg/dose every 8 hours) intravenous ondansetron for 24 hours. Clinical parameters including number of emesis episodes, nausea scores, appetite levels, parent's satisfaction, and adverse effects within 24 hours were analyzed.

Results: No significant differences were found between the two dosing strategies concerning number of emesis episodes and parent's satisfaction. However, nonleukemic hematologic malignancies and concurrent administration of intrathecal methotrexate-hydrocortisone-cytarabine (IT-MHA) were associated with increased risk of acute-phase vomiting. Interestingly, none of the patients aged under 7 years, receiving divided dosing ondansetron, presented nausea symptoms compared with those receiving single daily dosing (p-value .034). No significant differences regarding headache were observed between the two dosing strategies and none of the patients experienced QTc prolongation.

Conclusion: Ondansetron administered as divided dosing should be considered among children aged under 7 years to prevent chemotherapy-induced nausea and among patients receiving low emetogenic chemotherapy to maintain their appetite. Both administrative dosing strategies were well tolerated with no significant adverse effects.

Keywords: cancer; chemotherapy-induced nausea and vomiting (CINV); children; ondansetron; supportive care.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Antiemetics / administration & dosage
  • Antiemetics / therapeutic use*
  • Antineoplastic Agents / adverse effects*
  • Antineoplastic Agents / therapeutic use
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Child
  • Child, Preschool
  • Cytarabine / adverse effects
  • Cytarabine / therapeutic use
  • Double-Blind Method
  • Female
  • Hematologic Neoplasms / drug therapy
  • Humans
  • Hydrocortisone / adverse effects
  • Hydrocortisone / therapeutic use
  • Infant
  • Infant, Newborn
  • Male
  • Methotrexate / adverse effects
  • Methotrexate / therapeutic use
  • Nausea / chemically induced
  • Nausea / prevention & control*
  • Ondansetron / administration & dosage
  • Ondansetron / therapeutic use*
  • Prospective Studies
  • Vomiting / chemically induced
  • Vomiting / prevention & control*

Substances

  • Antiemetics
  • Antineoplastic Agents
  • Cytarabine
  • Ondansetron
  • Hydrocortisone
  • Methotrexate