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A Randomized, Double-blind Study of 2 Dose Levels of Kytril on the Prevention of Post-operative Nausea and Vomiting in Pediatric Patients Undergoing Surgery With General Anesthesia
This 2 arm study will evaluate the efficacy and safety of a single intravenous injection of Kytril in preventing postoperative nausea and vomiting (PONV) in children. Patients will be randomized to receive a single dose of either 20 micrograms or 40 micrograms Kytril intravenously (iv) 15 minutes prior to the end of surgery with general anesthesia for tonsillectomy or adenotonsillectomy. The anticipated time on study treatment is \<3 months, and the planned sample size was 170 patients.
Age
2 - 16 years
Sex
ALL
Healthy Volunteers
No
Fresno, California, United States
Stanford, California, United States
Hartford, Connecticut, United States
Miami, Florida, United States
Atlanta, Georgia, United States
Indianapolis, Indiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Pittsburgh, Pennsylvania, United States
Nashville, Tennessee, United States
Start Date
April 1, 2007
Primary Completion Date
December 1, 2007
Completion Date
December 1, 2007
Last Updated
March 27, 2018
171
ACTUAL participants
granisetron
DRUG
granisetron
DRUG
Lead Sponsor
Hoffmann-La Roche
NCT06326983
NCT05759481
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT03435003