NCT01395901

Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients

A Multicenter, Double-blind, Double-dummy, Randomized, Parallel Group, Stratified Study to Evaluate the Efficacy and Safety of a Single IV Dose of Palonosetron Compared to a Single IV Dose of Ondansetron to Prevent Postoperative Nausea and Vomiting in Pediatric Patients.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 670 (actual)
• Sponsor: Helsinn Healthcare SA · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the efficacy of a single palonosetron IV dose compared to a single ondansetron IV dose in the prevention of postoperative nausea and vomiting through 24 hours after surgery in children aged from neonates up to less than 17 years undergoing elective surgical procedures requiring general intravenous anesthesia. The secondary objective is to evaluate the safety and tolerability of IV palonosetron in pediatric patients.

Conditions

• Postoperative Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	Palonosetron	Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)
DRUG	Ondansetron	Single dose Ondansetron IV: * 0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for \>40 kg; * 13 years to less than 17 years dose: 4 mg
DRUG	Placebo to Ondansetron
DRUG	Placebo to Palonosetron

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-03-01
• Completion: 2012-04-01
• First posted: 2011-07-18
• Last updated: 2014-07-30
• Results posted: 2014-07-30

Locations

44 sites across 8 countries: United States, Argentina, Czechia, Hungary, Poland, Puerto Rico, Russia, Ukraine