Status:

UNKNOWN

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

Lead Sponsor:

University of Texas at Austin

Conditions:

Facial Laceration

Anxiety

Eligibility:

All Genders

1-7 years

Phase:

NA

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 present...

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 midazol...

Eligibility Criteria

Inclusion

  • Facial laceration requiring repair with sutures
  • English or Spanish-speaking parent/guardian

Exclusion

  • 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

Key Trial Info

Start Date :

March 1 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2021

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT04745260

Start Date

March 1 2021

End Date

December 31 2021

Last Update

February 9 2021

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