Comparing the Efficacy of Palonosetron versus Ondansetron in the Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients; A Randomized Controlled Trial

Abstract

Objectives: To compare the efficacy of Palonosetron and Ondansetron as premedication in the prevention of early and delayed chemotherapy-induced nausea and vomiting (CINV) in pediatric patients with cancer receiving moderately or highly emetogenic chemotherapy. Methodology: This randomized controlled trial study was conducted at the Oncology Department of Children’s Hospital, PIMS Islamabad, on patients aged 6 months to 12 years undergoing chemotherapy. Patients were divided in 2 groups by stratified random sampling and random allocation. Patients in Group 1 received a single intravenous dose of 20 microgram/kg Palonosetron and dexamethasone before chemotherapy, while Group 2 received intravenous Ondansetron 8 hourly along with dexamethasone. Nausea and vomiting severity were assessed from 0–120-hour interval using the CTCAE V 5.0 grading system. Data analysis was performed using SPSS version 23, employing chi-square and Fisher exact tests to compare outcomes between the two groups. Result: 218 pediatric oncology patients were included who received moderate or high intensity chemotherapy with the mean age of 5.25 ± 2.96 years. The majority of the participants were male (58.7%). The most common diagnosis was Wilms tumor (37.6%), followed by acute lymphoblastic leukemia (21.1%) and Ewing sarcoma (9.6%). Complete response to antiemetics was significantly more in Group 1 as compared to group 2, on day 1 and 2 with p value of 0.004 and 0.001 respectively. Grade of vomiting was significantly less on day in Group 1 study participants. Conclusion: Pediatric oncology patient receiving moderately or highly emetogenic chemotherapy showed effective response to palonosetron as compared to ondansetron in prevention and control of early and delayed chemotherapy induced nausea and vomiting.