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

Completed · Phase 3 · Has a placebo group

Conditions studied: Postoperative Nausea and Vomiting

In brief

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.

Key facts

Study ID: NCT01395901
Run by: Helsinn Healthcare SA
People needed: 670
Starts: 2011-06-01
Expected to finish: 2012-04-01
Last updated by the study team: 2014-07-30

Who can join

Age: any, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

Shoals Clinical Research Associates — Florence, Alabama, United States
Shoals Medical Research, LLC — Sheffield, Alabama, United States
Georgetown University Hospital — Washington D.C., District of Columbia, United States
Bascom Palmer Eye Institute - University of Miami — Miami, Florida, United States
Louisiana State University Health Sciences Center — Shreveport, Louisiana, United States
CRC of Jackson — Jackson, Mississippi, United States
Cooper University Hospital — Camden, New Jersey, United States
The University of North Carolina Hospitals — Chapel Hill, North Carolina, United States
Duke University Medical Center — Durham, North Carolina, United States
Clinical Trial Developers — Cincinnati, Ohio, United States
Texas Orthopedic Specialist, P.A — Grapevine, Texas, United States
Memorial Hermann Hospital — Houston, Texas, United States
CEMIC, Otorhinolaryngology Department — Buenos Aires, Argentina
Istituto Medico Rio Cuarto — Río Cuarto, Argentina
University Hospital Brno - Children's Medical Centre — Brno, Czechia
University Hospital Hradec Kralove — Hradec Králové, Czechia
University Hospital Olomouc — Olomouc, Czechia
University Hospital Pilsen- Paediatric Clinic — Plzen-Lochotin, Czechia
University Hospital Motol — Prague, Czechia
Hospital Znojmo, State-Funded Organisation, Department of Pediatrics — Znojmo, Czechia
Semmeleis University — Budapest, Hungary
St Istvan and St Laszlo Corporate Hospital; Paediatric Intensive Care Unit — Budapest, Hungary
The Municipal Council's St Janos Hospital and North Buda United Hospitals; Central Anaesthesiology and Intensive Care Unit — Budapest, Hungary
St Panthaleon Hospital; Central Department of Anaesthesiology and Intensive Care Unit — Dunaújváros, Hungary
Pandy Kalman County Hospital; Department of Central Anaesthesiology and Intensive Care Unit — Gyula, Hungary

Full record on ClinicalTrials.gov

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