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

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

MedlinePlus related topics:

Anesthesia Nausea and Vomiting Tonsils and Adenoids

ChemIDplus related topics:

Granisetron hydrochloride Granisetron

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, 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

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 ]

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
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, 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

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML16633
First Received:	September 30, 2005
Last Updated:	August 18, 2008
ClinicalTrials.gov Identifier:	NCT00231478
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms

Postoperative Nausea and Vomiting

Vomiting

Postoperative Complications

Signs and Symptoms, Digestive

Nausea

Granisetron

Serotonin

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on September 04, 2008

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