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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2021-12-31

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.

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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.

Conditions

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Facial Laceration Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

A non-blinded researcher (physician) will determine the group to which the patient is assigned and order the medication(s) according to the assigned group. A separate blinded researcher (physician) will then perform the laceration repair, mYPAS, and post-procedure evaluations. The non-blinded researcher, nurse, parent, and patient will be advised not to disclose which medication(s) were administered to ensure blinding of the provider performing the laceration repair and assessment.

Study Groups

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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).

Group Type EXPERIMENTAL

Intranasal Fentanyl Spray and Intranasal Midazolam Spray

Intervention Type DRUG

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

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).

Group Type ACTIVE_COMPARATOR

Intranasal Midazolam Spray

Intervention Type DRUG

Intranasal Midazolam 0.3mg/kg

Interventions

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Intranasal Fentanyl Spray and Intranasal Midazolam Spray

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

Intervention Type DRUG

Intranasal Midazolam Spray

Intranasal Midazolam 0.3mg/kg

Intervention Type DRUG

Other Intervention Names

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Versed Versed

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

Minimum Eligible Age

1 Year

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes