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Completed Phase 4 Interventional Results available

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

ClinicalTrials.gov ID: NCT00231478

Public ClinicalTrials.gov record NCT00231478. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 4, 2026, 7:31 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT00231478
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
171 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
2 Years to 16 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 31, 2007
Primary completion
Nov 30, 2007
Completion
Nov 30, 2007
Last update posted
Mar 26, 2018

2007

United States locations

U.S. sites
11
U.S. states
10
U.S. cities
11
Facility City State ZIP Site status
Not listed Fresno California 93720
Not listed Stanford California 94305-5118
Not listed Hartford Connecticut 06106
Not listed Miami Florida 33136
Not listed Atlanta Georgia 30322
Not listed Indianapolis Indiana 46223
Not listed Baltimore Maryland 21287
Not listed Boston Massachusetts 02114
Not listed Pittsburgh Pennsylvania 15213
Not listed Nashville Tennessee 37232
Not listed Dallas Texas 75235

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00231478, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 26, 2018 · Synced Sep 4, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00231478 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →