MedTrace Logo

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

NCT05057689 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2025-09-10

No results posted yet for this study

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

Interventions

DRUG

Intranasal Dexmedetomidine (4 mcg/kg)

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.

DRUG

Intranasal Fentanyl (2 mcg/kg)

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.

DRUG

Intranasal Midazolam (5 mg/kg)

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.

Sponsors & Collaborators

  • Nationwide Children's Hospital

    lead OTHER

Principal Investigators

  • Jonathan Chang, MD · University of Arkansas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2025-10-31
Completion
2025-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05057689 on ClinicalTrials.gov