Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Intervention: palonosetron; palonosetron
Intervention description: palonosetron IV 1 mcg/kg; palonosetron 3mcg/kg IV
Intervention MeSH terms: Palonosetron
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 150.0
Sex: All
Minimum age: 28 Days
Maximum age: 16 Years
Healthy volunteers: No
Keywords: Postoperative Nausea and Vomiting; palonosetron; pediatric

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.