Trial Information

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

Status: No longer recruiting

Protocol Number: ML16633

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific 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

Brief Summary: 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. Target sample size is 171.

Study Phase: IV

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Non-Randomized
• Masking: Open Label
• Control: Uncontrolled
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

Condition: Post-Operative Nausea and Vomiting

Intervention Type: Drug

Intervention Name: granisetron [Kytril]

Primary Outcome: 1. Percentage of patients with no vomiting Time frame: 0-2h after end of surgery (time of extubation)

Key Secondary Outcomes: 1. Percentage of patients with no vomiting Time frame: 0-24h after time of extubation 2. Time to first vomiting episode Time frame: Event driven 3. Adverse experiences Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 2 Years Max: 16 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: April, 2007

Trial Registration Date: 08/31/2005

Date Last Updated: 09/19/2008

Link To Trial Results

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Trial listings updated: October 6, 2008 at 2:50:22 PM