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.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00231478
First received: September 30, 2005
Last updated: May 16, 2011
Last verified: May 2011
  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 4

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Postoperative Nausea and Vomiting
Vomiting
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Signs and Symptoms, Digestive
Granisetron
Antiemetics
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014