IN Sub-Dissociative Ketamine vs IN Fentanyl

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This single center, randomized control, double blind trial will prospectively examine the feasibility of intranasal, sub-dissociative (IN) ketamine versus intranasal fentanyl for pain control in the pediatric emergency department setting. The investigators hypothesize that IN ketamine may provide a safe and effective alternative to IN fentanyl for children with suspected, isolated extremity fractures.

Eighty children ages 3-17 years with a suspected, isolated extremity fracture that requires analgesia will be randomized to receive IN ketamine or IN fentanyl upon presentation to the emergency department and will be followed for 2 hours for efficacy and 6 hours for safety.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Atrium Health; Carolinas Healthcare System
• Collaborators: Carolinas Trauma Network Research Group; Charlotte, Houston, Milwaukee Prehospital Emergency Research Nodal Center-CHaMP-ERNC
• Treatments: Acetaminophen; Analgesics; Fentanyl; Ibuprofen; Ketamine

Criteria

Inclusion Criteria:

• single suspected, isolated extremity fracture that requires analgesia

Exclusion Criteria:

• GCS < 15 at ED presentation,

• reported allergy or adverse reaction to ketamine or fentanyl,

• pregnancy,

• intoxication,

• hypotension (less than 70 mmHg +2x age or less than 90 mm Hg for patients greater than 11 years of age)

• weight > 70 kg

• patients receiving opioid analgesia administered prior to arrival

• multiply injured patients (injuries to multiple extremities)

• aberrant nasal anatomy that precludes IN medications