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

Post-Operative Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00231478
• Other study ID #: ML16633
• Status: Completed
• Phase: Phase 4
• First received: September 30, 2005
• Last updated: February 26, 2018
• Start date: April 2007
• Est. completion date: December 2007

Study information

• Verified date: February 2018
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Nausea
• Post-Operative Nausea and Vomiting
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• granisetron
20 micrograms intravenously (iv) 15 min prior to end of surgery
• granisetron
40 micrograms intravenously (iv) 15 min prior to end of surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Patients With no Vomiting	No vomiting describes no emesis during the first 24 hours	0-24h after time of extubation
Secondary	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
Secondary	Adverse Experiences	The adverse events are captured in the AE and SAE section of this database	infusion to 15 days post treatment