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

Hoffmann-La Roche171 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

171

Conditions

Post-Operative Nausea and Vomiting

Interventions

granisetron

Eligibility

Sex: ALLMin age: 2 YearsMax age: 16 Years

Medical Language ↔ Plain English

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

Locations (11)

Unnamed facility

Fresno, California, United States

Unnamed facility

Stanford, California, United States

Unnamed facility

Hartford, Connecticut, United States

Unnamed facility

Miami, Florida, United States

Unnamed facility

Atlanta, Georgia, United States

Unnamed facility

Indianapolis, Indiana, United States

Unnamed facility

Baltimore, Maryland, United States

Unnamed facility

Boston, Massachusetts, United States

Unnamed facility

Pittsburgh, Pennsylvania, United States

Unnamed facility

Nashville, Tennessee, United States

...and 1 more locations

Outcomes

Primary Outcomes

Number of Patients With no Vomiting

Number of patients with no vomiting is described as no emesis up to 2 hours after surgery

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

Secondary Outcomes

Number of Patients With no Vomiting

No vomiting describes no emesis during the first 24 hours

Time frame: 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.

Time frame: 0-24h after time of extubation

Adverse Experiences

The adverse events are captured in the AE and SAE section of this database

Time frame: infusion to 15 days post treatment