NCT04745260

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

A Randomized Controlled Trial of Intranasal Fentanyl in Combination With Midazolam Versus Midazolam Alone for Analgesia and Anxiolysis During Pediatric Facial Laceration Repair

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Texas at Austin · Academic / Other
• Sex: All
• Age: 1 Year – 7 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Facial Laceration
• Anxiety

Interventions

Type	Name	Description
DRUG	Intranasal Fentanyl Spray and Intranasal Midazolam Spray	Intranasal Fentanyl 2mcg/kg and Intranasal Midazolam 0.2mg/kg
DRUG	Intranasal Midazolam Spray	Intranasal Midazolam 0.3mg/kg

Timeline

• Start date: 2021-03-01
• Primary completion: 2021-11-01
• Completion: 2021-12-31
• First posted: 2021-02-09
• Last updated: 2021-02-09