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

Postoperative Nausea and Vomiting Clinical Trial

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 Vomiting in Pediatric Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00828295
• Other study ID #: PALO-07-29
• Status: Completed
• Phase: Phase 3
• First received: January 22, 2009
• Last updated: March 17, 2015
• Start date: August 2008
• Est. completion date: January 2009

Study information

• Verified date: July 2014
• Source: Helsinn Healthcare SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationRussia: Ethics CommitteeRussia: Ministry of Health of the Russian FederationRussia: Pharmacological Committee, Ministry of HealthUkraine: Ministry of HealthUkraine: State Pharmacological Center - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 16 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• palonosetron
palonosetron IV 1 mcg/kg
• palonosetron
palonosetron 3mcg/kg IV

Locations

Country	Name	City	State
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	Moscow
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"	St. Petersburg
Russian Federation	State Healthcare Institution 'Regional Pediatric Clinical Hospital'	Yaroslavl
Ukraine	Cherkassy Regional Hospital, Pediatric Surgery Department	Cherkassy
Ukraine	Regional Children's Clinical Hospital. Dnipropetrovsk State Medical Academy, Pediatric Surgery Department	Dnipropetrovsk
Ukraine	M.Gorkyi Donetsk National Medical University, Pediatric Surgery Department; Children's Regional Clinical Hospital	Donetsk
Ukraine	Regional Children's Hospital, ENT Department, Ivano-Frankivsk State Medical University, ENT Department	Ivano-Frankivsk
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	Kyiv
Ukraine	Children's Clinical Hospital "OKHMATDYT", Institute of Congenital Pathology under the Academy of Medical Sciences of Ukraine	Lviv

Sponsors (1)

Lead Sponsor	Collaborator
Helsinn Healthcare SA

Countries where clinical trial is conducted

Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Patients With no Emetic Episodes in the Overall Time Period 0-72 Hours Post-operatively		0-72 hours post-operatively	No
Secondary	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	No