Safety & Efficacy of Intranasal Dexmedetomidine, Fentanyl & Midazolam in the Pediatric Emergency Room

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The hypothesis is that intranasal dexmedetomidine will provide significantly more effective analgesia and anxiolysis for subjects undergoing a simple laceration repair when compared to either intranasal fentanyl or intranasal midazolam.

Additional hypotheses include that there will be 1) no significant increase in adverse effects between drugs and 2) significantly higher satisfaction rates for both subject experience and ease of laceration repair based on structured, proceduralist feedback.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Arkansas
• Treatments: Dexmedetomidine; Fentanyl; Midazolam

Criteria

Inclusion Criteria:

• Primary complaint of "laceration"

• 2 years to 6 years of age (inclusive)

• Initial presentation at the Arkansas Children's Hospital (ACH) Emergency Department

Exclusion Criteria:

• Prior allergic reaction to fentanyl or midazolam or dexmedetomidine

• Prior major adverse reaction to fentanyl or midazolam (e.g. seizure-like activity, paradoxical reaction, hallucinations)

• Nasal injury/deformity

• Potential for altered pain perception (e.g. autism, severe sensory-neural disturbances)

• History of adverse reaction to sedation/anesthesia

• History of cardiac arrhythmia

• History of liver dysfunction

• Concurrent injuries that would necessitate higher levels of care (e.g. inpatient admission, immediate evaluation in the operating room (OR), etc.)

• Complex (multi-layer) lacerations or those requiring subspecialty consultation for repair

• American Society of Anesthesiology (ASA) score ≥ 3

• Use of analgesics (with the exception of ibuprofen or acetaminophen) or anxiolytics in the immediate pre-examination period (within 4 hours)