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Sponsored by: |
Hoffmann-La Roche |
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Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00231478 |
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.
Condition | Intervention | Phase |
---|---|---|
Post-Operative Nausea and Vomiting |
Drug: granisetron [Kytril] |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 171 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | December 2007 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: granisetron [Kytril]
20 micrograms iv 15 min prior to end of surgery
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2: Experimental |
Drug: granisetron [Kytril]
40 micrograms iv 15 min prior to end of surgery
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Ages Eligible for Study: | 2 Years to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
STANFORD, California, United States, 94305-5118 | |
FRESNO, California, United States, 93720 | |
United States, Connecticut | |
HARTFORD, Connecticut, United States, 06106 | |
United States, Florida | |
MIAMI, Florida, United States, 33136 | |
United States, Georgia | |
ATLANTA, Georgia, United States, 30322 | |
United States, Indiana | |
INDIANAPOLIS, Indiana, United States, 46223 | |
United States, Maryland | |
BALTIMORE, Maryland, United States, 21287 | |
United States, Massachusetts | |
BOSTON, Massachusetts, United States, 02114 | |
United States, Pennsylvania | |
PITTSBURGH, Pennsylvania, United States, 15213 | |
United States, Tennessee | |
NASHVILLE, Tennessee, United States, 37232 | |
United States, Texas | |
DALLAS, Texas, United States, 75235 |
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | ML16633 |
Study First Received: | September 30, 2005 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00231478 |
Health Authority: | United States: Food and Drug Administration |
Signs and Symptoms Postoperative Nausea and Vomiting Vomiting Postoperative Complications |
Signs and Symptoms, Digestive Nausea Granisetron Serotonin |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Gastrointestinal Agents Antiemetics Pharmacologic Actions Serotonin Antagonists |
Pathologic Processes Serotonin Agents Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Central Nervous System Agents |