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

Completed · Phase 4

Conditions studied: Post-Operative Nausea and Vomiting

In brief

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.

Key facts

Study ID

NCT00231478

Run by

Hoffmann-La Roche

People needed

171

Starts

2007-04-01

Expected to finish

2007-12-01

Last updated by the study team

2018-03-27

Who can join

Age: 2 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Fresno, California, United States
• Study site — Stanford, California, United States
• Study site — Hartford, Connecticut, United States
• Study site — Miami, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Nashville, Tennessee, United States
• Study site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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