The Effect of Ondansetron During Intramuscular Ketamine Use in Children: A Trial in Emergency Department
Brief Summary
The purpose of this study is to evaluate the anti-emetic effect of oral ondansetron. For this evaluation, the investigators will perform a multi-center, double-blind, placebo-controled, randomized study. The investigators assumption is that oral ondansetron prior to intramuscular ketamine will reduce the occurrence of ketamine-induced vomiting.
Condition or Disease
- Sedation and Analgesia
- Side Effect of Drug
Phase
Study Design
| Study type: | Interventional |
|---|---|
| Status: | Unknown status |
| Study results: | No Results Available |
| Age: | 3 Months and older (Child, Adult, Older Adult) |
| Enrollment: | 266 () |
| Funded by: | Other |
Masking |
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Clinical Trial Dates
| Start date: | Nov 11, 2020 | |
|---|---|---|
| Primary Completion: | May 12, 2020 | |
| Completion Date: | May 12, 2020 | |
| Study First Posted: | Nov 22, 2011 | |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | Jan 20, 2012 |
Sponsors / Collaborators
Lead Sponsor:
N/A
Responsible Party:
N/A
Location
Methods
- a multi-center, double-blind, placebo-controled, randomized study ( 4 tertiary hospital ED)
- survey for the occurrence of vomiting at ED and after discharge
Primary outcome
- the number of vomiting at ED and at home
Secondary outcome
- parent's satisfaction and ED length of stay
Eligibility Criteria
| Sex: | All |
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More Details
| NCT Number: | NCT01477242 |
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| Other IDs: | H-1105-114-364 |
| Study URL: | https://ClinicalTrials.gov/show/NCT01477242 |
Last updated: Jan 28, 2021