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

Tracking Information

First Received Date ^ICMJE

September 30, 2005

Last Updated Date

May 13, 2009

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Percentage of patients with no vomiting [ Time Frame: 0-2h after end of surgery (time of extubation) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00231478 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Percentage of patients with no vomiting [ Time Frame: 0-24h after time of extubation ] [ Designated as safety issue: No ]
Time to first vomiting episode [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Adverse experiences [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Post-Operative Nausea and Vomiting

Intervention ^ICMJE

Drug: granisetron [Kytril]

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

170

Completion Date

December 2008

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

2 Years to 16 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00231478

Responsible Party

Clinical Trials, Study Director, Hoffmann-La Roche

Study ID Numbers ^ICMJE

ML16633

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

Information Provided By

Hoffmann-La Roche

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP