Clinical trial NCT00828295: Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Nausea and Vomiting
Keywords: Postoperative Nausea and Vomiting
palonosetron
pediatric
Lead sponsor: Helsinn Healthcare SA
Sponsor class: INDUSTRY
First posted: 2009-01-23
Enrollment: 150
Sex: ALL
Minimum age (years): 28
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of Patients With no Emetic Episodes in the Overall Time Period 0-72 Hours Post-operatively
timeFrame: 0-72 hours post-operatively
Secondary outcomes:
measure: Proportion of Patients With Complete Response 0-24 Hours
timeFrame: 0-24 hours
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Federal State Institution Central Research Institute of Traumatology and Orthopedics n.a. N.N. Priorov under the Federal Agency for High-Tech Medical Care
city: Moscow
country: Russian Federation
facility: Federal State Institution Moscow Research Institute of Pediatrics and Pediatric Surgery under the Federal Agency for High-Tech Medical Care
city: St. Petersburg
country: Russian Federation
facility: Federal State Institution St. Petersburg Research Institute of Ear, Throat, Nose and Speech under the Federal Agency for High-Tech Medical Care
city: St. Petersburg
country: Russian Federation
facility: State Higher Educational Institution: "St. Petersburg State Pediatric Medical Academy under the Federal Agency for Healthcare and Social Development"
city: Yaroslavl
country: Russian Federation
facility: State Healthcare Institution 'Regional Pediatric Clinical Hospital'
city: Cherkassy
country: Ukraine
facility: Cherkassy Regional Hospital, Pediatric Surgery Department
city: Dnipropetrovsk
country: Ukraine
facility: Regional Children's Clinical Hospital. Dnipropetrovsk State Medical Academy, Pediatric Surgery Department
city: Donetsk
country: Ukraine
facility: M.Gorkyi Donetsk National Medical University, Pediatric Surgery Department; Children's Regional Clinical Hospital
city: Ivano-Frankivsk
country: Ukraine
facility: Regional Children's Hospital, ENT Department, Ivano-Frankivsk State Medical University, ENT Department
city: Kyiv
country: Ukraine
facility: Specialized Children's Hospital "OKHMATDYT", Orthopedics and Traumatology Department, O.O. Bohomolets National Medical University, Pediatric Surgery Department
city: Kyiv
country: Ukraine
facility: 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
city: Kyiv
country: Ukraine
facility: Ukrainian Specialized Children's Hospital "OKHMATDYT", ENT Department, P.L. Shupyk National Medical Academy of Postgraduate Education, Pediatric ENT Department
city: Lviv
country: Ukraine
facility: Children's Clinical Hospital "OKHMATDYT", Institute of Congenital Pathology under the Academy of Medical Sciences of Ukraine
Study officials:
References: