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

Roche

Status and phase: Completed; Phase 4

Conditions: Post-Operative Nausea and Vomiting

Treatments: Drug: granisetron

Study type: Interventional

Funder types: Industry

Identifiers

NCT00231478

ML16633

Details and patient eligibility

About

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.

Enrollment: 171 patients

Sex: All

Ages: 2 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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171 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: granisetron

Drug: granisetron

2

Experimental group

Treatment:

Drug: granisetron

Drug: granisetron