WithdrawnEarly Phase 1ketamine

IN Dexmedetomidine for Procedural Sedation in Pediatric Closed Reductions for Distal Forearm Fractures

NCT ID

NCT03466242

Start Date

2017-01-01

Est. Completion

2020-03-01

About This Study

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 undergo conscious sedation for reduction of closed distal forearm fractures when compared to those receiving intravenous (IV) Ketamine. The secondary objective is to compare each sedation technique for safety and procedural outcomes.

Conditions Studied

Conscious SedationDistal Radius Fracture

Interventions

•Dexmedetomidine
•Ketamine

Eligibility

Age:2 Years - 18 Years

Healthy Volunteers:Yes

View full eligibility criteria

Inclusion Criteria:Verbal children aged 2-18 with a single extremity displaced forearm fracture requiring conscious sedation and reduction will be screened for enrollment.

Exclusion Criteria:

1. Under age 2 years old or patients \> 18 years old
2. Multiple Fractures
3. Significant multisystem trauma
4. Glasgow Coma Scale (GCS \< 15)
5. Complex fractures that aren't deemed reducible in ED
6. Reported Allergy to Alpha -2-agonists
7. Pregnancy
8. Intoxication
9. Baseline Hypotension as \< 70mm Hg + 2 x age or \< 90mm Hg for patients \> 11 years of age
10. Patients with prior reductions attempted at outside facilities
11. Aberrant nasal anatomy that precludes IN medications
12. Chronic Health issues that can affect DEX metabolism
13. History of adverse reactions to anesthesia
14. Patients transferred from outside facilities
15. Open fractures

Study Locations (1)

Phoenix Children's Hospital

Phoenix, Arizona, United States