A Study of Kytril (Granisetron) in the Prevention of Post-Operative Nausea and Vomiting (PONV) in Pediatric Subjects Undergoing Tonsillectomy or Adenotonsillectomy
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00231478
First received: September 30, 2005
Last updated: May 16, 2011
Last verified: May 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Post-Operative Nausea and Vomiting |
Drug: granisetron |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Number of Patients With no Vomiting [ Time Frame: 0-2h after end of surgery (time of extubation) ] [ Designated as safety issue: No ]Number of patients with no vomiting is described as no emesis up to 2 hours after surgery
Secondary Outcome Measures:
- Number of Patients With no Vomiting [ Time Frame: 0-24h after time of extubation ] [ Designated as safety issue: No ]No vomiting describes no emesis during the first 24 hours
- Time to First Vomiting Episode [ Time Frame: 0-24h after time of extubation ] [ Designated as safety issue: No ]Time to first vomiting is described as the first event of emesis in hours. Subjects not having a vomiting episode are censored at the total length of time (in hours) between the time of extubation and time of the 24 hour follow-up.
- Adverse Experiences [ Time Frame: infusion to 15 days post treatment ] [ Designated as safety issue: No ]The adverse events are captured in the AE and SAE section of this database
| Enrollment: | 171 |
| Study Start Date: | April 2007 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: granisetron
20 micrograms intravenously (iv) 15 min prior to end of surgery
Other Name: Kytril
|
| Experimental: 2 |
Drug: granisetron
40 micrograms intravenously (iv) 15 min prior to end of surgery
Other Name: Kytril
|
Eligibility| Ages Eligible for Study: | 2 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00231478
Locations
| United States, California | |
| Fresno, California, United States, 93720 | |
| Stanford, California, United States, 94305-5118 | |
| 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 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Clinical Trials, Study Director, Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00231478 History of Changes |
| Other Study ID Numbers: | ML16633 |
| Study First Received: | September 30, 2005 |
| Results First Received: | March 30, 2011 |
| Last Updated: | May 16, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Nausea Vomiting Postoperative Nausea and Vomiting Signs and Symptoms, Digestive Signs and Symptoms Postoperative Complications Pathologic Processes Granisetron Antiemetics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Gastrointestinal Agents Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 17, 2013