A Study of Kytril (Granisetron) in the Prevention of Post-Operative Nausea and Vomiting (PONV) in Pediatric Subjects Undergoing Tonsillectomy or Adenotonsillectomy
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 2 - 16 |
| Updated: | 4/17/2018 |
| Start Date: | April 2007 |
| End Date: | December 2007 |
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.
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.
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
We found this trial at
11
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials