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

Study Overview
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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.

Official Title
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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

Conditions
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Post-Operative Nausea and Vomiting

Intervention / Treatment
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* Drug: granisetron
* Drug: granisetron


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: granisetron<br>* 20 micrograms intravenously (iv) 15 min prior to end of surgery<br>* Other names: Kytril;|
| Experimental: 2<br> | Drug: granisetron<br>* 40 micrograms intravenously (iv) 15 min prior to end of surgery<br>* Other names: Kytril;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With no Vomiting | Number of patients with no vomiting is described as no emesis up to 2 hours after surgery | 0-2h after end of surgery (time of extubation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With no Vomiting | No vomiting describes no emesis during the first 24 hours | 0-24h after time of extubation | 
| Time to First Vomiting Episode | Time to first vomiting is described as the first event of emesis in hours. Subjects not having a vomiting episode are censored at the total length of time (in hours) between the time of extubation and time of the 24 hour follow-up. | 0-24h after time of extubation | 
| Adverse Experiences | The adverse events are captured in the AE and SAE section of this database | infusion to 15 days post treatment |