A Randomized Controlled Trial of Intranasal Fentanyl in Combination With Midazolam Versus Midazolam Alone for Analgesia and Anxiolysis During Pediatric Facial Laceration Repair
Overview
- Phase
- Not Applicable
- Intervention
- Intranasal Fentanyl Spray and Intranasal Midazolam Spray
- Conditions
- Facial Laceration
- Sponsor
- University of Texas at Austin
- Enrollment
- 100
- Primary Endpoint
- Modified Yale Preoperative Anxiety Score (mYPAS)
- Last Updated
- 5 years ago
Overview
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.
Investigators
Brittany DiFabio
Pediatric Emergency Medicine Fellow Physician
University of Texas at Austin
Eligibility Criteria
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
Arms & Interventions
Intranasal Midazolam and Intranasal Fentanyl
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).
Intervention: Intranasal Fentanyl Spray and Intranasal Midazolam Spray
Intranasal Midazolam
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).
Intervention: Intranasal Midazolam Spray
Outcomes
Primary Outcomes
Modified Yale Preoperative Anxiety Score (mYPAS)
Time Frame: 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 Outcomes
- Provider Satisfaction with Procedural Sedation (Visual Analog Score)(Immediately after the procedure)
- Parent Satisfaction with Anxiolysis (Visual Analog Scale)(Immediately after the procedure)
- Rate of Treatment Failure(Immediately after the procedure)
- Duration of Procedure(Immediately after the procedure)