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

NCT ID: NCT00828295

Last Updated: 2015-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2009-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

1 mcg/kg arm

Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)

Group Type: EXPERIMENTAL

palonosetron

Intervention Type: DRUG

palonosetron IV 1 mcg/kg

3 mcg/kg arm

Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)

Group Type: EXPERIMENTAL

palonosetron

Intervention Type: DRUG

palonosetron 3mcg/kg IV

Interventions

palonosetron

palonosetron IV 1 mcg/kg

Intervention Type: DRUG

palonosetron

palonosetron 3mcg/kg IV

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 28 Days
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helsinn Healthcare SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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, , Russia

Federal State Institution Moscow Research Institute of Pediatrics and Pediatric Surgery under the Federal Agency for High-Tech Medical Care

Moscow, , Russia

Federal State Institution St. Petersburg Research Institute of Ear, Throat, Nose and Speech under the Federal Agency for High-Tech Medical Care

Saint Petersburg, , Russia

State Higher Educational Institution: "St. Petersburg State Pediatric Medical Academy under the Federal Agency for Healthcare and Social Development"

Saint Petersburg, , Russia

State Healthcare Institution 'Regional Pediatric Clinical Hospital'

Yaroslavl, , Russia

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, , Ukraine

Countries

Russia; Ukraine

Other Identifiers

PALO-07-29

Identifier Type: -

Identifier Source: org_study_id