NCT00828295

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

A Multicenter, Double-blind, Randomized, Parallel Group, Stratified Study to Assess the Safety and Efficacy of Single IV Doses of Palonosetron to Prevent Postoperative Nausea and Vomiting in Pediatric Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Helsinn Healthcare SA · Industry
• Sex: All
• Age: 28 Days – 16 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to assess the safety and efficacy of two doses of IV palonosetron each administered as a single dose for the prevention of postoperative nausea and vomiting through 72 hours postoperatively in children aged 28 days up to 16 years inclusive undergoing surgical procedures requiring general endotracheal inhalation anesthesia.

Conditions

• Postoperative Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	palonosetron	palonosetron IV 1 mcg/kg
DRUG	palonosetron	palonosetron 3mcg/kg IV

Timeline

• Start date: 2008-08-01
• Primary completion: 2008-12-01
• Completion: 2009-01-01
• First posted: 2009-01-23
• Last updated: 2015-04-03
• Results posted: 2014-08-15

Locations

13 sites across 2 countries: Russia, Ukraine