UnknownNot Applicable

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

100 participantsStarted 2021-03-01

Plain-language 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.

Who can participate

Age range1 Year – 7 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Modified Yale Preoperative Anxiety Score (mYPAS)

Timeframe: Pre-procedure

Trial details

NCT IDNCT04745260

SponsorUniversity of Texas at Austin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-11-01

Contact for this trial

Brittany J DiFabio, MD

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

View on ClinicalTrials.gov More Facial Laceration trials