CompletedPhase 4

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

United States171 participantsStarted 2007-04

Plain-language 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.

Who can participate

Age range2 Years – 16 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of Patients With no Vomiting

Timeframe: 0-2h after end of surgery (time of extubation)

Trial details

NCT IDNCT00231478

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-12

Results submitted2011-03-30

View on ClinicalTrials.gov More Post-Operative Nausea and Vomiting trials