IN Dexmedetomidine for Procedural Sedation in Pediatric Closed Reductions for Distal Forearm Fractures
Brief Summary
Condition or Disease
- Conscious Sedation
- Distal Radius Fracture
Phase
Study Design
Study type: | Interventional |
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Status: | Unknown status |
Study results: | No Results Available |
Age: | 2 Years to 18 Years (Child, Adult) |
Enrollment: | 40 () |
Funded by: | Other |
Masking |
Clinical Trial Dates
Start date: | May 01, 2018 | |
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Primary Completion: | Apr 01, 2019 | |
Completion Date: | May 01, 2019 | |
Study First Posted: | Mar 15, 2018 | |
Results First Posted: | Aug 31, 2020 | |
Last Updated: | Mar 15, 2018 |
Sponsors / Collaborators
Location
Distal Forearm fractures are often are displaced requiring conscious sedation for closed reduction in the Emergency Department. Our institution's current standard of care consists of IN Fentanyl for baseline control of pain, and for those fractures requiring reduction; typically IV Ketamine is utilized. Ketamine is typically well tolerated but is not without concerns including hypertension, vomiting, and the rare but serious complication of laryngospasm. Dexmedetomidine (DEX) offers a possible alternative to IV Ketamine. DEX has been used safely in the critical care setting for both pediatrics and adults. It has been well documented as being quite effective in sedation, amnesia and analgesia. Using IN DEX for PED procedural sedation has the potential to obviate the need for IV placement and may offer a better conscious sedation profile than Ketamine with respect to sedation, analgesia, and adverse outcomes.
Our overall project would be to assess the efficiency of IN DEX in comparison to IV Ketamine, for proper sedation and analgesic coverage for children undergoing closed reduction of distal forearm fractures.
Eligibility Criteria
Sex: | All |
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Minimum Age: | 2 |
Maximum Age: | 18 |
More Details
NCT Number: | NCT03466242 |
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Other IDs: | 17-193 |
Study URL: | https://ClinicalTrials.gov/show/NCT03466242 |