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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2007-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Post-Operative Nausea and Vomiting

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

granisetron

Intervention Type DRUG

20 micrograms intravenously (iv) 15 min prior to end of surgery

2

Group Type EXPERIMENTAL

granisetron

Intervention Type DRUG

40 micrograms intravenously (iv) 15 min prior to end of surgery

Interventions

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granisetron

20 micrograms intravenously (iv) 15 min prior to end of surgery

Intervention Type DRUG

granisetron

40 micrograms intravenously (iv) 15 min prior to end of surgery

Intervention Type DRUG

Other Intervention Names

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Kytril Kytril

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No