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



Status:Archived
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:June 2011
End Date:May 2012
Contact:Ludmila Telizhenko, MD
Email:Ludmila.Telizhenko@psi-cro.com
Phone:+38 044 492 8560

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Trial Summary
Trial Overview
Inclusion Criteria

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.



We found this trial at
12
sites
Shoals Medical Research, LLC
Sheffield, Alabama 35660
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Cooper University Hospital
1 Cooper Plaza
Camden, New Jersey 08103
(856) 342-2000
Cooper University Hospital Cooper University Health Care, the clinical campus of Cooper Medical School of...
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University of North Carolina Hospitals
Chapel Hill, North Carolina 27599
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Chapel Hill, NC
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Clinical Trial Developers
Cincinnati, Ohio 45255
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Cincinnati, OH
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Duke Univ Med Ctr
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Shoals Clinical Research Associates
Florence, Alabama 35630
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Florence, AL
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Texas Orthopedic Specialist, P.A
Grapevine, Texas 76051
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Grapevine, TX
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Memorial Hermann Hospital
Houston, Texas 77030
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Houston, TX
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CRC of Jackson
Jackson, Mississippi 39202
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Jackson, MS
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Bascom Palmer Eye Institute, University of Miami
Miami, Florida 33136
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Miami, FL
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Louisiana State University Health Sciences Center
Shreveport, Louisiana 71130
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Shreveport, LA
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Georgetown University Hospital
3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 444-2000
Georgetown University Hospital MedStar Georgetown University Hospital is a not-for-profit, acute-care teaching and research hospital...
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