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

Phoenix Children's Hospital

Status and phase: Withdrawn; Early Phase 1

Conditions: Conscious Sedation; Distal Radius Fracture

Treatments: Drug: Ketamine; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT03466242

17-193

Details and patient eligibility

About

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.

Full 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 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.

Sex: All

Ages: 2 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Intranasal Dexmedetomidine

Experimental group

Description:

Evaluate sedative and analgesic effects of Intranasal Dexmedetomidine (1-2ug/kg)

Treatment:

Drug: Dexmedetomidine

IV Ketamine

Active Comparator group

Description:

Evaluate sedative and analgesic effects of Intravenous Ketamine (1mg/kg)

Treatment:

Drug: Ketamine