Last updated: 11/07/2018 18:30:16
A Randomized, Double-blind, Placebo-controlled, Multi-center Study of Intravenous Ondansetron Hydrochloride 0.1 mg/kg for the Prevention of Postoperative Emesis in Pediatric Surgical Subjects Ages 1 Month to 24 Months Who Are Undergoing Routine Surgery Under General Anesthesia.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Study of Intravenous Ondansetron Hydrochloride 0.1 mg/kg for the Prevention of Postoperative Emesis in Pediatric Surgical Subjects Ages 1 Month to 24 Months Who Are Undergoing Routine Surgery Under General Anesthesia.
Trial description: A Randomized, Double-blind, Placebo-controlled, Multi-center Study of Intravenous Ondansetron Hydrochloride 0.1 mg/kg for the Prevention of Postoperative Emesis in Pediatric Surgical Subjects Ages 1 Month to 24 Months Who Are Undergoing Routine Surgery Under General Anesthesia.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
A double-blind comparison of intravenous ondansetron and placebo for preventing postoperative emesis in 1- to 24-month-old pediatric patients after surgery under general anesthesia. Khalil, S. N., Roth, A. G., Cohen, I. T., Simhi, E., Ansermino, J. M., Bolos, M. E., Cote, C. J., Hannallah, R. S., Davis, P. J., Brooks, P. B., Russo, M. W., Anschuetz, G. C., and Blackburn, L. M. Anesth Analg 2005; 101 (2):356-61
Ondansetron in Prevention of Postoperative Emesis in 1 to 24 Month Old Pediatric Patients, Samia Khalil, M.D., Andrew Roth, M.D., Ira Cohen, M.D., Eli Simhi, M.D., Mark Anser-mino, M.D. 55th Annual Meeting of the American Society of Anesthesiologists. 10/23/2004 Las Vegas, NV; USA
Medical condition
Nausea and Vomiting, Postoperative
Product
ondansetron
Collaborators
Not applicable
Study date(s)
December 2002 to July 2003
Type
Not applicable
Phase
3
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2003-23-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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