Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Helsinn Healthcare SA
Age
0–16
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients
