Status:
COMPLETED
A Study of Kytril (Granisetron) in the Prevention of Post-Operative Nausea and Vomiting (PONV) in Pediatric Subjects Undergoing Tonsillectomy or Adenotonsillectomy
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Post-Operative Nausea and Vomiting
Eligibility:
All Genders
2-16 years
Phase:
PHASE4
Brief Summary
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 re...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
171 Patients enrolled
Trial Details
Trial ID
NCT00231478
Start Date
April 1 2007
End Date
December 1 2007
Last Update
March 27 2018
Active Locations (11)
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1
Fresno, California, United States, 93720
2
Stanford, California, United States, 94305-5118
3
Hartford, Connecticut, United States, 06106
4
Miami, Florida, United States, 33136