Status:
COMPLETED
Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients
Lead Sponsor:
Helsinn Healthcare SA
Conditions:
Postoperative Nausea and Vomiting
Eligibility:
All Genders
28-16 years
Phase:
PHASE3
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 ho...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00828295
Start Date
August 1 2008
End Date
January 1 2009
Last Update
April 3 2015
Active Locations (13)
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1
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
2
Federal State Institution Moscow Research Institute of Pediatrics and Pediatric Surgery under the Federal Agency for High-Tech Medical Care
Moscow, Russia
3
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
4
State Higher Educational Institution: "St. Petersburg State Pediatric Medical Academy under the Federal Agency for Healthcare and Social Development"
Saint Petersburg, Russia