Phase 4
Completed N=171
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
Source: ClinicalTrials.gov NCT00231478 ↗
Enrolled (actual)
171
Serious AEs
5.1%
Results posted
Apr 2011
Primary outcomePrimary: Number of Patients With no Vomiting — 61; 69 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With no Vomiting |
49; 50 | — |
| SECONDARY Number of Patients With no Vomiting |
49; 50 | — |
| SECONDARY Time to First Vomiting Episode |
18.0; 17.8 | — |
| SECONDARY Adverse Experiences |
79; 78 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00231478). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.