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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Postoperative Nausea and Vomiting

Intervention / Treatment
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* Drug: palonosetron
* Drug: palonosetron


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 28 Days
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative Nausea and Vomiting, palonosetron, pediatric