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; Ondansetron; Placebo to Ondansetron; Placebo to Palonosetron
Intervention description: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg); 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
Intervention MeSH terms: Ondansetron; 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: 670.0
Sex: All
Maximum age: 16 Years
Healthy volunteers: No
Keywords: Prevention of Postoperative Nausea and Vomiting; Palonosetron; Ondansetron; Pediatric

Summary:

      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.
    

Eligibility criteria:

        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