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

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.