Lidocaine vs Diphenhydramine for Skin Lacerations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Florida Atlantic University

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Diphenhydramine, when injected locally, has been shown to achieve a certain level of local anesthesia. It has been documented for use in simple bedside procedures, however there is a gap in knowledge in its comparison to lidocaine. The purpose of the study is to determine if local infiltration of diphenhydramine is noninferior to the use of lidocaine 1% when trying to achieve local anesthesia for simple laceration repair. Patients who present to the emergency department with a simple laceration will be enrolled in the study. Patients will be evaluated for the pain of the injection as well as the pain of the laceration repair procedure post injection.

Research Team

Eligibility Criteria

This trial is for individuals who come to the emergency department with simple lacerations that need only one layer of sutures and can be treated by emergency physicians. It's not suitable for those with complex wounds, active bleeding, allergies to lidocaine or diphenhydramine, or if their repair would benefit from epinephrine.

Inclusion Criteria

My cut can be treated by emergency doctors.

I have cuts that needed stitches.

Exclusion Criteria

I am currently bleeding from a cut.

My cut needs to be treated by a specialist.

Patients with allergies to either diphenhydramine or lidocaine

Treatment Details

Interventions

• Diphenhydramine (Antihistamine)
• Lidocaine (Local Anesthetic)

Trial Overview The study compares two local anesthetics: Lidocaine and Diphenhydramine. Patients will receive one of these drugs before their laceration is sutured. The goal is to see if Diphenhydramine's effectiveness in numbing pain is as good as Lidocaine's during the procedure.

Participant Groups

Group I: Diphenhydramine Experimental Treatment 1 Intervention

Group II: Lidocaine Active Control 1 Intervention

Who Is Running the Clinical Trial?

Florida Atlantic University

Lead Sponsor

Trials

35

Recruited

10,700+

Baptist Health South Florida

Collaborator

Trials

54

Recruited

8,100+