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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

Brief 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.

Detailed Summary:
Sponsor: Helsinn Healthcare SA

Current Primary Outcome: Proportion of Patients With Complete Response [ Time Frame: 0-24 hours after T0 ]

Complete Response was defined as no vomiting, no retching, and no use of antiemetic rescue medication during the first 24 hours postoperatively, starting at T0. Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Proportion of Patients With no Vomiting [ Time Frame: 0-24 hours after T0 ]
    Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively.
  • Proportion of Patients Without Emetic Episodes [ Time Frame: 0-24 hours after T0 ]
    An emetic episode was defined as one or more continuous vomits (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively.
  • Proportion of Patients Without Antiemetic Rescue Medication [ Time Frame: 0-24 hours after T0 ]
    Rescue medications are any medications with potential antiemetic effect taken in the 24 hours after patient wake-up from anaesthesia (T0).Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively.
  • Proportion of Patients Without Nausea (Patient Aged > 6 Years) [ Time Frame: 0-24 hours after T0 ]


Original Secondary Outcome:

  • Proportion of patients with no emetic episodes in different time periods [ Time Frame: 0-6 hours, 6-24 hours, 24-48 hours, 48-72 hours, 0-24 hours, 0-48 hours and 24-72 hours ]
  • Severity of nausea (only for patients aged 6 up to 16 years inclusive) in different time periods [ Time Frame: 0-6 hours, 6-24 hours, 24-48 hours, and 48-72 hours; and at the overall time period (0-72 hours) ]


Information By: Helsinn Healthcare SA

Dates:
Date Received: January 22, 2009
Date Started: August 2008
Date Completion:
Last Updated: July 29, 2014
Last Verified: July 2014