Ketamine Infusion for Pediatric Patients With Obstructive Sleep Apnea Syndrome (OSAS) After Tonsillectomy
Brief Summary
The study will evaluate the post-operative morphine-sparing effect, pain reduction, and side effects of a continuous ketamine infusion after tonsillectomy in pediatric patients.
Condition or Disease
- Obstructive Sleep Apnea Syndrome
Phase
Study Design
| Study type: | Interventional |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 1 Year to 17 Years (Child) |
| Enrollment: | 36 () |
| Funded by: | Other |
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Clinical Trial Dates
| Start date: | Dec 14, 2022 | |
|---|---|---|
| Primary Completion: | May 03, 2018 | |
| Completion Date: | May 03, 2018 | |
| Study First Posted: | Apr 23, 2015 | |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | Oct 15, 2018 |
Sponsors / Collaborators
Lead Sponsor:
N/A
Responsible Party:
N/A
Location
Eligible pediatric patients that are undergoing tonsillectomy for sleep-disordered breathing or obstructive sleep apnea AND are to be admitted into a monitored setting will be recruited for this study. They will be randomized into two groups:1) Control group receiving continuous infusion of saline (placebo) and 2) Study group receiving continuous infusion of low-dose ketamine at 0.1 mg/kg/hr. Both patients will receive scheduled oral acetaminophen and rescue intravenous morphine as required. The infusions will be stopped at 0600 the next morning. Morphine requirements, pain scores at selected times, central nervous system side effects, and adverse cardiorespiratory events will be recorded.
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 1 |
| Maximum Age: | 17 |
More Details
| NCT Number: | NCT02425202 |
|---|---|
| Acronym: | KOSATA |
| Other IDs: | B2013:163 |
| Study URL: | https://ClinicalTrials.gov/show/NCT02425202 |
Last updated: Jun 17, 2022