This study will evaluate the efficacy and safety of a single intravenous injection of Kytril in preventing PONV in children. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.

Condition	Intervention	Phase
Post-Operative Nausea and Vomiting	Drug: granisetron [Kytril]	Phase IV

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures: 

• Efficacy: Proportion of patients with no vomiting during the 0-2 hour interval following the end of surgery (time of extubation)

Secondary Outcome Measures: 

• Efficacy: Proportion of patients with no vomiting during the 0-24 hour interval following time of extubation; time to first vomiting episode following time of extubation. Safety: Adverse experiences

Ages Eligible for Study:  2 Years   -   16 Years,  Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00231478

Please reference Study ID Number: RLI_ML16633      973-235-5000 
or      800-526-6367 (FOR US ONLY) 

United States, California
      SAN DIEGO,  California,  92123,  United States
      STANFORD,  California,  94305-5118,  United States
United States, Connecticut
      HARTFORD,  Connecticut,  06106,  United States
United States, District of Columbia
      WASHINGTON,  District of Columbia,  20010,  United States
United States, Florida
      MIAMI,  Florida,  33136,  United States
United States, Georgia
      ATLANTA,  Georgia,  30322,  United States
United States, Illinois
      CHICAGO,  Illinois,  60614-3394,  United States
United States, Indiana
      INDIANAPOLIS,  Indiana,  46223,  United States
United States, Maryland
      BALTIMORE,  Maryland,  21287,  United States
United States, Michigan
      ANN ARBOR,  Michigan,  48109-0934,  United States
United States, Pennsylvania
      PITTSBURGH,  Pennsylvania,  15213,  United States
United States, Texas
      HOUSTON,  Texas,  77024,  United States
      DALLAS,  Texas,  75235,  United States
United States, Wisconsin
      MILWAUKEE,  Wisconsin,  53227,  United States

Study ID Numbers:  ML16633
Last Updated:  April 16, 2007
Record first received:  September 30, 2005
ClinicalTrials.gov Identifier:  NCT00231478
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on May 08, 2007