Recruiting
Phase 3

Diphenhydramine vs. Lidocaine

Sponsor:

Florida Atlantic University

Code:

NCT06910241

Conditions

Laceration of Skin

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Lidocaine

Diphenhydramine

Study Details

Brief summary:

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.

Conditions

Laceration of Skin

Study ID

NCT06910241

Start date

Sep 3, 2025

Status verified date

Jan, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Lacerations requiring one layer of sutures
  • Lacerations appropriate for repair by emergency physicians

Exclusion Criteria:

  • Active bleeding from laceration
  • Complex lacerations requiring multiple layers
  • Lacerations to be repaired by a specialist service
  • Patients with allergies to either diphenhydramine or lidocaine
  • Laceration repairs would benefit from the use of epinephrine as an additive to the local anesthetic

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Lidocaine

experimental: Diphenhydramine

Interventions

Lidocaine

Lidocaine local infiltration

Diphenhydramine

Diphenhydramine local infiltration

Primary outcome measure

  • Sensation reduction [ Time Frame: Measurements will be recorded before drug injection and immediately after laceration repair. ]

Central Contacts and Locations

Locations

Bethesda Hospital East

Recruiting

Boynton Beach, Florida, United States, 33435

Contacts

More Information

Sponsor

Florida Atlantic University

Last update posted

Jan 7, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Florida Atlantic University on 2026-01-07.