NCT05057689

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

A Double-blinded, Randomized Trial Comparing the Safety & Efficacy of Intranasal Dexmedetomidine, Intranasal Fentanyl & Intranasal Midazolam in the Pediatric Emergency Room

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Nationwide Children's Hospital · Academic / Other
• Sex: All
• Age: 2 Years – 6 Years
• Healthy volunteers: Accepted

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.

Detailed description

Intranasal medications are rapidly gaining popularity as agents for analgesia and anxiolysis in the pediatric hospital setting. One of the primary reasons for the popularity of intranasal medications is ease of administration combined with favorable pharmacokinetics. It has been well established that children identify venipuncture as one of the most painful and anxiety-producing procedures during time spent in the hospital, and these experiences have been shown to have a more lasting impact, producing increased anxiety and fear at subsequent visits. Although oral and rectal administration of analgesics are also non-invasive, bioavailability, time to onset, and half-lives are significantly longer with these routes of administration in comparison to intranasal administration. Multiple studies have shown that intranasal fentanyl, midazolam, and dexmedetomidine have similar pharmacokinetics to intravenous preparations and reach adequate serum levels in both the blood and cerebrospinal fluid. In the pediatric emergency room setting, intranasal fentanyl and midazolam have been shown to provide effective analgesia and anxiolysis for a variety of settings, including pain management (e.g. pain associated with long bone fractures, burns, incision and drainage) and pre-procedural sedation/anxiolysis (e.g. radiological imaging).Numerous studies have examined the safety and efficacy of intranasal fentanyl and midazolam, and several studies have examined the efficacy of intranasal dexmedetomidine for non-painful procedural sedation. To date, two studies have compared the use of intranasal dexmedetomidine and intranasal midazolam or intranasal dexmedetomidine, intranasal fentanyl, and intranasal midazolam for anxiolysis in painful procedural sedations. However, as of 2020, no previous studies have compared the use of intranasal dexmedetomidine, intranasal fentanyl, and intranasal midazolam for painful procedures in the pediatric emergency setting.

Conditions

• Acute Stress Disorder
• Anxiety
• Pain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-09-01
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2021-09-27
• Last updated: 2025-09-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study