A Study of Kytril (Granisetron) in the Prevention of Post-Operative Nausea and Vomiting (PONV) in Pediatric Subjects Undergoing Tonsillectomy or Adenotonsillectomy - Full Text View

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00231478

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 IV

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:

MedlinePlus related topics: Nausea and Vomiting Tonsils and Adenoids

Drug Information available for: Granisetron hydrochloride Granisetron

U.S. FDA Resources

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 February 12, 2012