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

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

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 Overview

• Status: Completed
• Conditions: Post-Operative Nausea and Vomiting
• Intervention / Treatment: Drug: granisetron; Drug: granisetron

• Study Type: Interventional
• Enrollment (Actual): 171
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Fresno, California, United States, 93720
    • Stanford, California, United States, 94305-5118
  • Connecticut
    • Hartford, Connecticut, United States, 06106
  • Florida
    • Miami, Florida, United States, 33136
  • Georgia
    • Atlanta, Georgia, United States, 30322
  • Indiana
    • Indianapolis, Indiana, United States, 46223
  • Maryland
    • Baltimore, Maryland, United States, 21287
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
  • Tennessee
    • Nashville, Tennessee, United States, 37232
  • Texas
    • Dallas, Texas, United States, 75235

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: granisetron; 20 micrograms intravenously (iv) 15 min prior to end of surgery; Other Names: Kytril; Drug: granisetron; 40 micrograms intravenously (iv) 15 min prior to end of surgery; Other Names: Kytril
Experimental: 2	Drug: granisetron; 20 micrograms intravenously (iv) 15 min prior to end of surgery; Other Names: Kytril; Drug: granisetron; 40 micrograms intravenously (iv) 15 min prior to end of surgery; Other Names: Kytril

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: September 30, 2005
• First Submitted That Met QC Criteria: September 30, 2005
• First Posted (Estimate): October 4, 2005

Study Record Updates

• Last Update Posted (Actual): March 27, 2018
• Last Update Submitted That Met QC Criteria: February 26, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Serotonin Agents; Serotonin Antagonists; Granisetron
• Other Study ID Numbers: ML16633