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 primary objective of this study is to evaluate the efficacy of a single palonosetron IV dose compared to a single ondansetron IV dose in the prevention of postoperative nausea and vomiting through 24 hours after surgery in children aged from neonates up to less than 17 years undergoing elective surgical procedures requiring general intravenous anesthesia. The secondary objective is to evaluate the safety and tolerability of IV palonosetron in pediatric patients.

Official Title
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A Multicenter, Double-blind, Double-dummy, Randomized, Parallel Group, Stratified Study to Evaluate the Efficacy and Safety of a Single IV Dose of Palonosetron Compared to a Single IV Dose of Ondansetron 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: Ondansetron
* Drug: Placebo to Ondansetron
* Drug: Placebo to Palonosetron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patient aged from full term neonate to less than 17 years. In-patient or out-patient scheduled to undergo one of the following procedures: ear, nose and throat surgery (e.g., tonsillectomy, adenoidectomy, myringotomy), eye surgery (e.g. strabismus, vitreoretinal, cataract surgery), urological surgery (e.g. orchidopexy, varicocoele), plastic reconstructive surgery (e.g. cleft lip/cleft palate, burn procedures involving the scalp), hernia repair, orthopedic surgery (e.g. foot and ankle deformities, arthroscopic surgeries, ACL surgery),. cardiac surgery, neurosurgery. Patient is scheduled to undergo surgery requiring general intravenous anesthesia Patient is scheduled to receive nitrous oxide during the maintenance phase of anesthesia Patient weighs at least 3.2 kg ASA physical status I, II or III Fertile patients (male or female) must use reliable contraceptive measures Female patients who have attained menarche must have a negative pregnancy test at the screening visit (Visit 1) and at study treatment visit (Visit 2) For patients with known hepatic impairment: in the Investigator's opinion, the impairment does not jeopardize the patient's safety during the study For patients with known renal impairment: in the Investigator's opinion, the impairment does not jeopardize the patient's safety during the study Exclusion Criteria: Lactating females Patient aged ≤6 years who received any investigational drug within 90 days prior to Day 1, or patient aged >6 years who received any investigational drug within 30 days prior to Day 1 or is expected to receive investigational drugs prior to study completion. Patient having participated in any previous trial with palonosetron. History of allergy to any components or any other contraindications to the use of any 5-HT3 receptor antagonists Patient to undergo emergency surgery Patient scheduled to receive regional anesthesia (lumbar, epidural, spinal) alone or in conjunction with general intravenous anesthesia Patient scheduled to receive laryngeal mask anesthesia Patient scheduled to receive propofol during the maintenance phase of anesthesia Patient suffering from any concomitant disease uncontrolled by therapy, which, in the judgment of the Investigator, could compromise the outcome of surgery Patient with history of gastro-esophageal reflux (except for patients up to 12 months) Patient with ongoing vomiting from any organic cause Patient having experienced any vomiting, retching, or nausea within 24 hours prior to the administration of the study drug

Ages Eligible for Study
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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: Palonosetron and placebo to Ondansetron<br>Intervention: Drug: Palonosetron | Drug: Palonosetron<br>* Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)<br>Drug: Placebo to Ondansetron<br> <br> |
| Active Comparator: Ondansetron and placebo to Palonosetron<br>Intervention: Drug: Comparator: Ondansetron | Drug: Ondansetron<br>* Single dose Ondansetron IV: 0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg; 13 years to less than 17 years dose: 4 mg<br>Drug: Placebo to Palonosetron<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients With Complete Response | Complete Response was defined as no vomiting, no retching, and no use of antiemetic rescue medication during the first 24 hours postoperatively, starting at T0. Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively. | 0-24 hours after T0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients With no Vomiting | Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively. | 0-24 hours after T0 | 
| Proportion of Patients Without Emetic Episodes | An emetic episode was defined as one or more continuous vomits (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively. | 0-24 hours after T0 | 
| Proportion of Patients Without Antiemetic Rescue Medication | Rescue medications are any medications with potential antiemetic effect taken in the 24 hours after patient wake-up from anaesthesia (T0).Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively. | 0-24 hours after T0 | 
| Proportion of Patients Without Nausea (Patient Aged > 6 Years) |  | 0-24 hours after T0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention of Postoperative Nausea and Vomiting, Palonosetron, Ondansetron, Pediatric