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

• Status: Unknown status
• Trial end date: 2019-05-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Phoenix Children's Hospital
• Treatments: Analgesics; Dexmedetomidine; Hypnotics and Sedatives; Ketamine

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