Intranasal Fentanyl in Combination With Midazolam Versus Midazolam Alone for Pediatric Facial Laceration Repair

The University of Texas System (UT)

Status: Unknown

Conditions: Facial Laceration; Anxiety

Treatments: Drug: Intranasal Midazolam Spray; Drug: Intranasal Fentanyl Spray and Intranasal Midazolam Spray

Study type: Interventional

Funder types: Other

Identifiers

NCT04745260

2020040016

Details and patient eligibility

About

The purpose of the study is to compare the effectiveness of a combination of intranasal fentanyl and intranasal midazolam to intranasal midazolam alone for analgesia and anxiolysis in patients presenting for facial laceration repair in the pediatric emergency department.

Full description

This study will be a single blind (blinded observer) randomized control trial to evaluate the efficacy of the combination of intranasal fentanyl and intranasal midazolam compared to intranasal midazolam alone for analgesia and anxiolysis during pediatric facial laceration repair.

Enrollment: 100 estimated patients

Sex: All

Ages: 1 to 7 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Facial laceration requiring repair with sutures
• English or Spanish-speaking parent/guardian

Exclusion criteria

• Lacerations requiring IV sedation or subspecialist involvement
• Patient has other injuries requiring medical attention
• Patient has vital sign instability, per physician discretion
• Patient has autism spectrum disorder
• Patient has allergies to either medication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

Intranasal Midazolam and Intranasal Fentanyl

Experimental group

Description:

Study participants assigned to the combination (experimental) group will receive a weight-based dose of intranasal Fentanyl (50mcg/mL concentration at 2mcg/kg up to 100mcg) followed by intranasal Midazolam (5mg/mL concentration at 0.2mg/kg up to 10mg) using a mucosal atomizer device (1mL syringe with an attached atomizer).

Treatment:

Drug: Intranasal Fentanyl Spray and Intranasal Midazolam Spray

Intranasal Midazolam

Active Comparator group

Description:

Study participants assigned to the control (active comparator) group will receive only intranasal Midazolam (5mg/mL concentration at 0.3mg/kg up to 10mg) using a mucosal atomizer device (1mL syringe with an attached atomizer).

Treatment:

Drug: Intranasal Midazolam Spray