Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting 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