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

This study is ongoing, but not recruiting participants.

Sponsored by: 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

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




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