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

Not Applicable

• Conditions: Facial Laceration; Anxiety
• Interventions: Drug: Intranasal Fentanyl Spray and Intranasal Midazolam Spray; Drug: Intranasal Midazolam Spray

• Registration Number: NCT04745260
• Lead Sponsor: University of Texas at Austin

Brief 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.

Study Timeline

• Study First Submitted: 2021-01-31
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-06
• Last Update Submitted: 2021-02-06
• Study First Posted: 2021-02-09
• Last Update Posted: 2021-02-09
• Study Start: 2021-03-01
• Primary Completion: 2021-11-01
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intranasal Midazolam and Intranasal Fentanyl	Intranasal Fentanyl Spray and Intranasal Midazolam Spray	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).
Intranasal Midazolam	Intranasal Midazolam Spray	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).

Primary Outcome Measures

Name	Time	Method
Modified Yale Preoperative Anxiety Score (mYPAS)	Pre-procedure	mYPAS score at time of positioning, to be completed by blinded researcher (provider) to assess anxiety level. Scores range from 22.5 to 100, with higher scores indicating greater anxiety.

Secondary Outcome Measures

Name	Time	Method
Provider Satisfaction with Procedural Sedation (Visual Analog Score)	Immediately after the procedure	VAS (visual analog score) completed by blinded researcher (provider) to rate satisfaction with level of sedation and ease of procedure. The scale will range from 0 (unsatisfied) to 100 (very satisfied).
Parent Satisfaction with Anxiolysis (Visual Analog Scale)	Immediately after the procedure	VAS (visual analog score) completed by parent to rate satisfaction with level of anxiolysis for procedure. The scale will range from 0 (unsatisfied) to 100 (very satisfied).
Rate of Treatment Failure	Immediately after the procedure	Failure of intervention to provide appropriate anxiolysis and need for IV sedation
Duration of Procedure	Immediately after the procedure	Duration of procedure from positioning to last suture placement, to be recorded by blinded researcher (provider)