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.
1 other identifier
interventional
670
8 countries
44
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2011
Shorter than P25 for phase_3
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 14, 2011
CompletedFirst Posted
Study publicly available on registry
July 18, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedResults Posted
Study results publicly available
July 30, 2014
CompletedJuly 30, 2014
July 1, 2014
9 months
July 14, 2011
June 27, 2014
July 29, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Patients With Complete Response
Complete Response was defined as no vomiting, no retching, and no use of antiemetic rescue medication during the first 24 hours postoperatively, starting at T0. Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively.
0-24 hours after T0
Secondary Outcomes (4)
Proportion of Patients With no Vomiting
0-24 hours after T0
Proportion of Patients Without Emetic Episodes
0-24 hours after T0
Proportion of Patients Without Antiemetic Rescue Medication
0-24 hours after T0
Proportion of Patients Without Nausea (Patient Aged > 6 Years)
0-24 hours after T0
Study Arms (2)
Palonosetron and placebo to Ondansetron
EXPERIMENTALIntervention: Drug: Palonosetron
Ondansetron and placebo to Palonosetron
ACTIVE COMPARATORIntervention: Drug: Comparator: Ondansetron
Interventions
Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)
Single dose Ondansetron IV: * 0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for \>40 kg; * 13 years to less than 17 years dose: 4 mg
Eligibility Criteria
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
- +3 more criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
Shoals Clinical Research Associates
Florence, Alabama, 35630, United States
Shoals Medical Research, LLC
Sheffield, Alabama, 35660, United States
Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Bascom Palmer Eye Institute - University of Miami
Miami, Florida, 33136, United States
Louisiana State University Health Sciences Center
Shreveport, Louisiana, 71103, United States
CRC of Jackson
Jackson, Mississippi, 39202, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
The University of North Carolina Hospitals
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Clinical Trial Developers
Cincinnati, Ohio, 45255, United States
Texas Orthopedic Specialist, P.A
Grapevine, Texas, 76051, United States
Memorial Hermann Hospital
Houston, Texas, 77030, United States
CEMIC, Otorhinolaryngology Department
Buenos Aires, C1431FWO, Argentina
Istituto Medico Rio Cuarto
Río Cuarto, X5800AEV, Argentina
University Hospital Brno - Children's Medical Centre
Brno, 61300, Czechia
University Hospital Hradec Kralove
Hradec Králové, 500 05, Czechia
University Hospital Olomouc
Olomouc, 775 20, Czechia
University Hospital Pilsen- Paediatric Clinic
Plzen-Lochotin, 30460, Czechia
University Hospital Motol
Prague, 15006, Czechia
Hospital Znojmo, State-Funded Organisation, Department of Pediatrics
Znojmo, 669 02, Czechia
Semmeleis University
Budapest, 1083, Hungary
St Istvan and St Laszlo Corporate Hospital; Paediatric Intensive Care Unit
Budapest, 1097, Hungary
The Municipal Council's St Janos Hospital and North Buda United Hospitals; Central Anaesthesiology and Intensive Care Unit
Budapest, 1125, Hungary
St Panthaleon Hospital; Central Department of Anaesthesiology and Intensive Care Unit
Dunaújváros, 2400, Hungary
Pandy Kalman County Hospital; Department of Central Anaesthesiology and Intensive Care Unit
Gyula, 5700, Hungary
Department of Pediatric Surgery and Urology of Medical University of Gdansk
Gdansk, 80-803, Poland
Department of Pediatric Anesthesiology and Intensive Care
Lodz, 91-738, Poland
Department of Pediatric Anesthesiology and Intensive Care
Lublin, 20-093, Poland
Department of Intensive Care and Anesthesiology
Olsztyn, 10-561, Poland
Department of Pediatric Surgery
Wroclaw, 50-369, Poland
University Pediatric Hospital
San Juan, PR 00936, Puerto Rico
State Healthcare Institution Arkhangelsk Regional Children's Hospital
Arkhangelsk, 132002, Russia
Federal State Institution: St. Petersburg Research Institute of Ear, Throat, Nose and Speech under the MoH Care and Social Development of the Russian Federation
Saint Petersburg, 190013, Russia
International Clinic MEDEM
Saint Petersburg, 191025, Russia
St. Petersburg State Pediatric Medical Academy
Saint Petersburg, 194100, Russia
Yaroslavl Region State Healthcare Institution
Yaroslavl, 150042, Russia
Dnipropetrovsk Regional Childrens Clinical Hospital
Dnipropetrovsk, 49100, Ukraine
Regional Childrens Clinical Hospital
Donetsk, 83052, Ukraine
Ivano-Frankivsk Regional Childrens Clinical Hospital
Ivano-Frankivsk, 76000, Ukraine
City Clinical Hospital n#30
Kharkiv, 61000, Ukraine
Research and Development Center for Prophylactic and Clinical Medicine
Kyiv, 01133, Ukraine
National Specialized Childrens Hospital OKHMATDYT
Kyiv, 01135, Ukraine
V.P. Filatov Institute of Eye Diseases and Tissue Therapy
Odesa, 65061, Ukraine
Zaporizhia Regional Clinical Childrens Hospital
Zaporizhia, 69000, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Salvatore Chessari
- Organization
- Helsinn Healthcare SA
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2011
First Posted
July 18, 2011
Study Start
June 1, 2011
Primary Completion
March 1, 2012
Study Completion
April 1, 2012
Last Updated
July 30, 2014
Results First Posted
July 30, 2014
Record last verified: 2014-07