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

University of Texas at Austin100 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

100

Conditions

Facial Laceration Anxiety

Interventions

Intranasal Fentanyl Spray and Intranasal Midazolam SprayDRUG

Intranasal Fentanyl 2mcg/kg and Intranasal Midazolam 0.2mg/kg

Intranasal Midazolam SprayDRUG

Intranasal Midazolam 0.3mg/kg

Eligibility

Sex: ALLMin age: 1 YearMax age: 7 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Pre-procedure

Secondary Outcomes

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).

Time frame: 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).

Time frame: Immediately after the procedure

Rate of Treatment Failure

Failure of intervention to provide appropriate anxiolysis and need for IV sedation

Time frame: Immediately after the procedure

Duration of Procedure

Duration of procedure from positioning to last suture placement, to be recorded by blinded researcher (provider)

Time frame: Immediately after the procedure

Central Contacts

Brittany J DiFabio, MD

CONTACT

512-324-0093 brittany.difabio@ascension.org

Matthew Wilkinson, MD

CONTACT

512-324-0093 mhwilkinson@ascension.org

Data from ClinicalTrials.gov

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