Back to resultsA Study of Kytril (Granisetron) in the Prevention of Post-Operative Nausea and Vomiting (PONV) in Pediatric Subjects Undergoing Tonsillectomy or Adenotonsillectomy
Primary Purpose
Post-Operative Nausea and Vomiting
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
granisetron
granisetron
Sponsored by
About this trial
This is an interventional treatment trial for Post-Operative Nausea and Vomiting
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Number of Patients With no Vomiting
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
No vomiting describes no emesis during the first 24 hours
Time to First Vomiting Episode
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
The adverse events are captured in the AE and SAE section of this database
Full Information
NCT ID
NCT00231478
First Posted
September 30, 2005
Last Updated
February 26, 2018
Sponsor
Hoffmann-La Roche
1. Study Identification
Unique Protocol Identification Number
NCT00231478
Brief Title
A Study of Kytril (Granisetron) in the Prevention of Post-Operative Nausea and Vomiting (PONV) in Pediatric Subjects Undergoing Tonsillectomy or Adenotonsillectomy
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 Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Operative Nausea and Vomiting
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
171 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
granisetron
Other Intervention Name(s)
Kytril
Intervention Description
20 micrograms intravenously (iv) 15 min prior to end of surgery
Intervention Type
Drug
Intervention Name(s)
granisetron
Other Intervention Name(s)
Kytril
Intervention Description
40 micrograms intravenously (iv) 15 min prior to end of surgery
Primary Outcome Measure Information:
Title
Number of Patients With no Vomiting
Description
Number of patients with no vomiting is described as no emesis up to 2 hours after surgery
Time Frame
0-2h after end of surgery (time of extubation)
Secondary Outcome Measure Information:
Title
Number of Patients With no Vomiting
Description
No vomiting describes no emesis during the first 24 hours
Time Frame
0-24h after time of extubation
Title
Time to First Vomiting Episode
Description
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.
Time Frame
0-24h after time of extubation
Title
Adverse Experiences
Description
The adverse events are captured in the AE and SAE section of this database
Time Frame
infusion to 15 days post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5118
Country
United States
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46223
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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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