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

NCT05057689 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 261081
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Stress Disorder; Anxiety; Pain

Outcome Measures

Primary Outcomes (2)

• Pain using the Face, Legs, Activity, Cry, Consolability (FLACC) scale

  Analgesia in subjects undergoing simple laceration repair will be compared across the three investigational drug products (intranasal dexmedetomidine, intranasal fentanyl, and intranasal midazolam) using the FLACC scale.

  through the procedure, an average of 1 day

• Anxiety using the modified Yale Preoperative Anxiety Scale (mYPAS) behavior observation tool

  Anxiolysis in subjects undergoing simple laceration repair will be compared across the three investigational drug products (intranasal dexmedetomidine, intranasal fentanyl, and intranasal midazolam) using the modified Yale Preoperative Anxiety Scale (mYPAS) behavior observation tool.

  through the procedure, an average of 1 day

Secondary Outcomes (2)

• Satisfaction rates for subject experience across the three study drugs based on parent/legally authorized representative (LAR) survey

  within 1 week of the laceration repair, average of 5 days

• Satisfaction rates for surgical repair across the three study drugs based on proceduralist survey

  within 1 week of the laceration repair, average of 5 days

Study Arms (3)

Intranasal Dexmedetomidine (4 mcg/kg)

EXPERIMENTAL

Dexmedetomidine 100 mcg/mL (concentration of 200 mcg/2 mL) will be atomized for intranasal administration at a dose of 4 mcg/kg (0.04 mL/kg) according to a weight-based dosing chart. The maximum dose will be 200 mcg.

Drug: Intranasal Dexmedetomidine (4 mcg/kg)

Intranasal Fentanyl (2 mcg/kg)

EXPERIMENTAL

Fentanyl 50 mcg/mL (concentration of 100 mcg/2 mL) will be atomized for intranasal administration at a dose of 2 mcg/kg (0.04 mL/kg) according to a weight-based dosing chart. The maximum dose will be 100 mcg.

Drug: Intranasal Fentanyl (2 mcg/kg)

Intranasal Midazolam (5 mg/kg)

EXPERIMENTAL

Midazolam 5 mg/mL (concentration of 10 mg/2 mL) will be atomized for intranasal administration at a dose of 0.3 mg/kg (0.06 mL/kg) according to a weight-based dosing chart. The maximum dose will be 10 mg

Drug: Intranasal Midazolam (5 mg/kg)

Interventions

Intranasal Dexmedetomidine (4 mcg/kg) DRUG

Dexmedetomidine 100 mcg/mL (concentration of 200 mcg/2 mL) will be atomized for intranasal administration at a dose of 4 mcg/kg (0.04 mL/kg) according to a weight-based dosing chart prior to laceration repair. The maximum dose will be 200 mcg.

Also known as: Precedex

Intranasal Dexmedetomidine (4 mcg/kg)

Intranasal Fentanyl (2 mcg/kg) DRUG

Fentanyl 50 mcg/mL (concentration of 100 mcg/2 mL) will be atomized for intranasal administration at a dose of 2 mcg/kg (0.04 mL/kg) according to a weight-based dosing chart prior to laceration repair. The maximum dose will be 100 mcg.

Also known as: Fentanyl Citrate

Intranasal Fentanyl (2 mcg/kg)

Intranasal Midazolam (5 mg/kg) DRUG

Midazolam 5 mg/mL (concentration of 10 mg/2 mL) will be atomized for intranasal administration at a dose of 0.3 mg/kg (0.06 mL/kg) according to a weight-based dosing chart prior to laceration repair. The maximum dose will be 10 mg.

Intranasal Midazolam (5 mg/kg)

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Primary complaint of "laceration"
• years to 6 years of age (inclusive)
• Initial presentation at the Arkansas Children's Hospital (ACH) Emergency Department

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

MeSH Terms

Conditions

Stress Disorders, Traumatic, Acute; Anxiety Disorders; Pain

Interventions

Dexmedetomidine; Fentanyl

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines

Study Officials

• Jonathan Chang, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: September 27, 2021
• Study Start: September 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-09

Locations

US (1)