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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Facial Laceration, Anxiety

Intervention / Treatment
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* Drug: Intranasal Fentanyl Spray and Intranasal Midazolam Spray
* Drug: Intranasal Midazolam Spray


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intranasal Midazolam and Intranasal Fentanyl<br>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). | Drug: Intranasal Fentanyl Spray and Intranasal Midazolam Spray<br>* Intranasal Fentanyl 2mcg/kg and Intranasal Midazolam 0.2mg/kg<br>* Other names: Versed;|
| Active Comparator: Intranasal Midazolam<br>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). | Drug: Intranasal Midazolam Spray<br>* Intranasal Midazolam 0.3mg/kg<br>* Other names: Versed;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Yale Preoperative Anxiety Score (mYPAS) | 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. | Pre-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Provider Satisfaction with Procedural Sedation (Visual Analog Score) | 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). | Immediately after the procedure | 
| Parent Satisfaction with Anxiolysis (Visual Analog Scale) | 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). | Immediately after the procedure | 
| Rate of Treatment Failure | Failure of intervention to provide appropriate anxiolysis and need for IV sedation | Immediately after the procedure | 
| Duration of Procedure | Duration of procedure from positioning to last suture placement, to be recorded by blinded researcher (provider) | Immediately after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laceration repair, Facial laceration, Anxiety, Midazolam, Fentanyl