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

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.

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.

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