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Therapeutic Areas: Oncology | Trauma/Emergency Medicine | Cardiology/Vascular Diseases
Disease Category: Surgery
Trial Information
A Study of Kytril (Granisetron) in the Prevention of Post-Operative Nausea and Vomiting (PONV) in Pediatric Subjects Undergoing Tonsillectomy or Adenotonsillectomy
Status: Completed
Protocol Number: ML16633
Sponsor: Hoffmann-La Roche
Company Division: Pharmaceutical
Official Scientific 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
Brief 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.
Target sample size is 171.
Study Phase: IV
Study Design / Study Details:
- Purpose: Treatment
- Allocation: Non-Randomized
- Masking: Open Label
- Control: Uncontrolled
- Assignment: Parallel
- Endpoints: Safety/Efficacy
Study Type:
Interventional
Condition: Post-Operative Nausea and Vomiting
Intervention Type: Drug
Intervention Name: granisetron [Kytril]
Primary Outcome: 1. Percentage of patients with no vomiting Time frame: 0-2h after end of surgery (time of extubation)
Key Secondary Outcomes: 1. Percentage of patients with no vomiting Time frame: 0-24h after time of extubation
2. Time to first vomiting episode Time frame: Event driven
3. Adverse experiences Time frame: Throughout study
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
Gender: Males or Females
Age Limits: Min: 2 Years Max: 16 Years
Accepts Healthy Volunteers: No
Trial Registration Date: 08/31/2005
Date Last Updated: 05/18/2009
Link To Trial Results
E-mail: genentechclinicaltrials@druginfo.com
Research Site:
Located In:
Fresno, CA 93721
Phone: 888-662-6728 (U.S. Only)
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