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.

First Received: September 30, 2005 Last Updated: May 13, 2009 History of Changes

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 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

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia Nausea and Vomiting Surgery 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:

Percentage of patients with no vomiting [ Time Frame: 0-2h after end of surgery (time of extubation) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of patients with no vomiting [ Time Frame: 0-24h after time of extubation ] [ Designated as safety issue: No ]
Time to first vomiting episode [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Adverse experiences [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	170
Study Completion Date:	December 2008

Arms	Assigned Interventions
1: Experimental	Drug: granisetron [Kytril] 20 micrograms iv 15 min prior to end of surgery
2: Experimental	Drug: granisetron [Kytril] 40 micrograms iv 15 min prior to end of surgery

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

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

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML16633
Study First Received:	September 30, 2005
Last Updated:	May 13, 2009
ClinicalTrials.gov Identifier:	NCT00231478 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neurotransmitter Agents
Postoperative Nausea and Vomiting
Vomiting
Molecular Mechanisms of Pharmacological Action
Signs and Symptoms, Digestive
Physiological Effects of Drugs
Gastrointestinal Agents
Antiemetics
Pharmacologic Actions
Signs and Symptoms

Serotonin Antagonists
Serotonin Agents
Pathologic Processes
Postoperative Complications
Autonomic Agents
Therapeutic Uses
Nausea
Granisetron
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 11, 2009