Actively Recruiting

Phase 3
Age: 18Years +
All Genders
Healthy Volunteers
ID06910241

Lidocaine Versus Diphenhydramine to Achieve Local Anesthesia for Laceration Repairs

Led by Florida Atlantic University · Updated on 2026-01-07

100

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

F

Florida Atlantic University

Lead Sponsor

B

Baptist Health South Florida

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the use of diphenhydramine injected locally to achieve local anesthesia compared to lidocaine 1% in patients with simple skin lacerations. The study aims to determine if diphenhydramine is not worse than lidocaine for numbing the area during laceration repair. This Phase 3 clinical trial focuses on patients presenting to the emergency department who require simple laceration repair with one layer of sutures. Participants will be randomly assigned to receive either lidocaine or diphenhydramine as a local injection before the laceration repair procedure. Both treatments are given by local infiltration, and the study is double-blinded so neither patients nor physicians know which drug is administered. The treatments are compared for their ability to reduce sensation and provide anesthesia during the repair. During the study, researchers will measure sensation reduction before injection and immediately after the laceration repair. They will also assess patient and physician satisfaction with the anesthesia right after the procedure. The study includes patients aged 18 years and older and may involve healthy volunteers. Participation involves receiving the local injection and undergoing the laceration repair while pain and anesthesia effects are carefully monitored.

CONDITIONS

Brief Title

Lidocaine Versus Diphenhydramine to Achieve Local Anesthesia for Laceration Repairs

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Lacerations requiring one layer of sutures
  • Lacerations appropriate for repair by emergency physicians
Not Eligible

You will not qualify if you...

  • Active bleeding from the laceration
  • Complex lacerations requiring multiple layers
  • Lacerations needing repair by a specialist
  • Allergies to diphenhydramine or lidocaine
  • Lacerations that would benefit from epinephrine added to the anesthetic

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single treatment session

Participants receive local anesthesia with either lidocaine or diphenhydramine to repair their lacerations.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Bethesda Hospital East

Boynton Beach, Florida, United States, 33435

Actively Recruiting

Loading map...

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

Anxiolysis for Laceration Repair in Children: A Multicenter ...

Laceration of Skin

Actively Recruiting

1 location

Randomized Controlled Trial of Intranasal Midazolam vs Dexme...

Laceration of Skin

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here