A Study of Kytril (Granisetron) in the Prevention of Post-Operative Nausea and Vomiting (PONV) in Pediatric Subjects Undergoing Tonsillectomy or Adenotonsillectomy
Information source: Hoffmann-La Roche
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post-Operative Nausea and Vomiting
Intervention: granisetron [Kytril] (Drug); granisetron [Kytril] (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000
Summary
This 2 arm study will evaluate the efficacy and safety of a single intravenous injection of
Kytril in preventing PONV in children. Patients will be randomized to receive a single dose
of either 20 micrograms or 40 micrograms Kytril 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 target sample size is 100-500 individuals.
Clinical Details
Official title: 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
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Percentage of patients with no vomiting
Secondary outcome: Percentage of patients with no vomitingTime to first vomiting episode Adverse experiences
Eligibility
Minimum age: 2 Years.
Maximum age: 16 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- males and females 2-16 years of age
- scheduled to undergo elective surgery for tonsillectomy or adenotonsillectomy
requiring general anesthesia and endotracheal intubation
- scheduled for hospital admission for no longer than 24 hours
Exclusion Criteria:
- known allergy or other contraindication to the use of Kytril or any of its components
- known allergy to any other 5HT3 antagonist
- history of motion sickness or post-operative nausea or vomiting
- nausea or vomiting in the 24 hours prior to anesthesia
Locations and Contacts
STANFORD, California 94305-5118, United States
FRESNO, California 93720, United States
HARTFORD, Connecticut 06106, United States
MIAMI, Florida 33136, United States
ATLANTA, Georgia 30322, United States
INDIANAPOLIS, Indiana 46223, United States
BALTIMORE, Maryland 21287, United States
BOSTON, Massachusetts 02114, United States
PITTSBURGH, Pennsylvania 15213, United States
NASHVILLE, Tennessee 37232, United States
DALLAS, Texas 75235, United States
Additional Information
Starting date: April 2007
Ending date: December 2007
Last updated: June 17, 2008
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