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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

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ClinicalTrials.gov Identifier: NCT00231478
Recruitment Status : Completed
First Posted : October 4, 2005
Results First Posted : April 28, 2011
Last Update Posted : March 27, 2018
Sponsor:
Information provided by:
Hoffmann-La Roche

Brief Summary:
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 or disease Intervention/treatment Phase
Post-Operative Nausea and Vomiting Drug: granisetron Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 171 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Number of Patients With no Vomiting [ Time Frame: 0-2h after end of surgery (time of extubation) ]
    Number of patients with no vomiting is described as no emesis up to 2 hours after surgery


Secondary Outcome Measures :
  1. Number of Patients With no Vomiting [ Time Frame: 0-24h after time of extubation ]
    No vomiting describes no emesis during the first 24 hours

  2. Time to First Vomiting Episode [ Time Frame: 0-24h after time of extubation ]
    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.

  3. Adverse Experiences [ Time Frame: infusion to 15 days post treatment ]
    The adverse events are captured in the AE and SAE section of this database



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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00231478     History of Changes
Other Study ID Numbers: ML16633
First Posted: October 4, 2005    Key Record Dates
Results First Posted: April 28, 2011
Last Update Posted: March 27, 2018
Last Verified: February 2018

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
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action