Status:
WITHDRAWN
IN Dexmedetomidine for Procedural Sedation in Pediatric Closed Reductions for Distal Forearm Fractures
Lead Sponsor:
Phoenix Children's Hospital
Conditions:
Conscious Sedation
Distal Radius Fracture
Eligibility:
All Genders
2-18 years
Phase:
EARLY_PHASE1
Brief Summary
The primary objective of this study is to evaluate the sedative, and analgesic effects of intranasal (IN) Dexmedetomidine (DEX) in children presenting to a Pediatric Emergency Department (PED) who und...
Detailed Description
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 b...
Eligibility Criteria
Inclusion
- Verbal children aged 2-18 with a single extremity displaced forearm fracture requiring conscious sedation and reduction will be screened for enrollment.
Exclusion
- Under age 2 years old or patients \> 18 years old
- Multiple Fractures
- Significant multisystem trauma
- Glasgow Coma Scale (GCS \< 15)
- Complex fractures that aren't deemed reducible in ED
- Reported Allergy to Alpha -2-agonists
- Pregnancy
- Intoxication
- Baseline Hypotension as \< 70mm Hg + 2 x age or \< 90mm Hg for patients \> 11 years of age
- Patients with prior reductions attempted at outside facilities
- Aberrant nasal anatomy that precludes IN medications
- Chronic Health issues that can affect DEX metabolism
- History of adverse reactions to anesthesia
- Patients transferred from outside facilities
- Open fractures
Key Trial Info
Start Date :
January 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03466242
Start Date
January 1 2017
End Date
March 1 2020
Last Update
November 24 2025
Active Locations (1)
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1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016