Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00231478
Status:
COMPLETED
Last Update Posted:
2018-03-27
First Post:
2005-09-30
Brief Title:
A Study of Kytril Granisetron in the Prevention of Post-Operative Nausea and Vomiting PONV in Pediatric Subjects Undergoing Tonsillectomy or Adenotonsillectomy
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None