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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Nausea and Vomiting
• Intervention / Treatment: Drug: palonosetron; Drug: palonosetron

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • Federal State Institution Central Research Institute of Traumatology and Orthopedics n.a. N.N. Priorov under the Federal Agency for High-Tech Medical Care
  • Moscow, Russian Federation
    • Federal State Institution Moscow Research Institute of Pediatrics and Pediatric Surgery under the Federal Agency for High-Tech Medical Care
  • St. Petersburg, Russian Federation
    • Federal State Institution St. Petersburg Research Institute of Ear, Throat, Nose and Speech under the Federal Agency for High-Tech Medical Care
  • St. Petersburg, Russian Federation
    • State Higher Educational Institution: "St. Petersburg State Pediatric Medical Academy under the Federal Agency for Healthcare and Social Development"
  • Yaroslavl, Russian Federation
    • State Healthcare Institution 'Regional Pediatric Clinical Hospital'
• Ukraine
  • Cherkassy, Ukraine
    • Cherkassy Regional Hospital, Pediatric Surgery Department
  • Dnipropetrovsk, Ukraine
    • Regional Children's Clinical Hospital. Dnipropetrovsk State Medical Academy, Pediatric Surgery Department
  • Donetsk, Ukraine
    • M.Gorkyi Donetsk National Medical University, Pediatric Surgery Department; Children's Regional Clinical Hospital
  • Ivano-Frankivsk, Ukraine
    • Regional Children's Hospital, ENT Department, Ivano-Frankivsk State Medical University, ENT Department
  • Kyiv, Ukraine
    • Specialized Children's Hospital "OKHMATDYT", Orthopedics and Traumatology Department, O.O. Bohomolets National Medical University, Pediatric Surgery Department
  • Kyiv, Ukraine
    • Ukrainian Specialized Children's Hospital "OKHMATDYT", Anesthesiology and Intensive Care Department, P.L. Shupyk National Medical Academy of Postgraduate Education, Pediatric Anesthesiology and Intensive Care Department
  • Kyiv, Ukraine
    • Ukrainian Specialized Children's Hospital "OKHMATDYT", ENT Department, P.L. Shupyk National Medical Academy of Postgraduate Education, Pediatric ENT Department
  • Lviv, Ukraine
    • Children's Clinical Hospital "OKHMATDYT", Institute of Congenital Pathology under the Academy of Medical Sciences of Ukraine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

MAIN INCLUSION CRITERIA

• Male or female patient aged more than 28 days (full term) up to and including 16 years.

• Inpatient scheduled to undergo surgical procedures requiring general endotracheal anesthesia, including:

  • ear, nose and throat surgery;
  • eye surgery;
  • orchidopexy;
  • plastic reconstructive surgery;
  • herniorraphy;
  • orthopedic surgery).
• American Society of Anesthesiologists (ASA) physical status I, II or III.
• Patient scheduled to receive nitrous oxide during the maintenance phase of anesthesia.
• Patient scheduled to be hospitalized for at least 72 hours after wake up of surgery
• For female of childbearing potential: the patient and her parent(s)/legal guardian(s) were counseled on the importance of not becoming pregnant before or during the study and the patient must have a negative pregnancy test at the pre-treatment visit and at the study treatment visit.

MAIN EXCLUSION CRITERIA

• For infant aged more than 12 months: a history of gastro-esophageal reflux.
• For patient aged 28 days to 6 years: patient who received any investigational drugs within 90 days prior to Day 1. For patient aged 6 up to 16 years inclusive: patient who received any investigational drugs within 30 days prior to Day 1.
• Patient scheduled to undergo emergency surgery.
• Patient scheduled to receive regional (spinal) anesthesia in conjunction with general endotracheal anesthesia.
• Patient scheduled to receive propofol during the maintenance phase of anesthesia.
• Patient with vomiting from any organic cause.
• Any drug with a potential anti-emetic effect within 24 hours prior to the administration of anesthesia.
• Any vomiting, retching, or nausea in the 24 hours preceding the administration of anesthesia.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1 mcg/kg arm; Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)	Drug: palonosetron; palonosetron IV 1 mcg/kg; Drug: palonosetron; palonosetron 3mcg/kg IV
Experimental: 3 mcg/kg arm; Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)	Drug: palonosetron; palonosetron IV 1 mcg/kg; Drug: palonosetron; palonosetron 3mcg/kg IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of Patients With no Emetic Episodes in the Overall Time Period 0-72 Hours Post-operatively	0-72 hours post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Patients With Complete Response 0-24 Hours	Complete Response defined as no vomiting, no retching, and no use of rescue medication	0-24 hours

Collaborators and Investigators

• Sponsor: Helsinn Healthcare SA

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: January 22, 2009
• First Submitted That Met QC Criteria: January 22, 2009
• First Posted (Estimate): January 23, 2009

Study Record Updates

• Last Update Posted (Estimate): April 3, 2015
• Last Update Submitted That Met QC Criteria: March 17, 2015
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: pediatric; Postoperative Nausea and Vomiting; palonosetron
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Serotonin Agents; Serotonin Antagonists; Serotonin 5-HT3 Receptor Antagonists; Palonosetron
• Other Study ID Numbers: PALO-07-29