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

Phase 4

Completed

• Conditions: Post-Operative Nausea and Vomiting
• Interventions: Drug: granisetron

• Registration Number: NCT00231478
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-09-30
• Study First Submitted QC: 2005-09-30
• Study First Posted: 2005-10-04
• Study Start: 2007-04
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Results First Submitted: 2011-03-30
• Results First Submitted QC: 2011-03-30
• Results First Posted: 2011-04-28
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-26
• Last Update Posted: 2018-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 171

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	granisetron	-
2	granisetron	-

Primary Outcome Measures

Name	Time	Method
Number of Patients With no Vomiting	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

Name	Time	Method
Number of Patients With no Vomiting	0-24h after time of extubation	No vomiting describes no emesis during the first 24 hours
Time to First Vomiting Episode	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.
Adverse Experiences	infusion to 15 days post treatment	The adverse events are captured in the AE and SAE section of this database