Lidocaine Versus Diphenhydramine to Achieve Local Anesthesia for Laceration Repairs

NCT06910241 | Recruiting Phase 3 FDA Drug

• 1 other identifier: 2195722
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Sensation reduction

  Participants will rate their sensation level on a visual analog scale from 0 to 10 both before the drug injection and after the laceration repair procedure. 0 indicating no sensation and 10 indicating worst sensation. Reduction in sensation will be calculated as the difference between the pre-injection and post-procedure sensation, with a larger number indicating a greater reduction in sensation.

  Measurements will be recorded before drug injection and immediately after laceration repair.

Secondary Outcomes (2)

• Anesthesia satisfaction by patient

  Immediately after laceration repair

• Anesthesia satisfaction by physician

  Immediately after laceration repair

Study Arms (2)

Lidocaine

ACTIVE COMPARATOR

Drug: Lidocaine

Diphenhydramine

EXPERIMENTAL

Drug: Diphenhydramine

Interventions

Lidocaine DRUG

Lidocaine local infiltration

Lidocaine

Diphenhydramine DRUG

Diphenhydramine local infiltration

Diphenhydramine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida Atlantic University: lead
• Baptist Health South Florida: collaborator

Study Sites (1)

Bethesda Hospital East

Boynton Beach, Florida, 33435, United States

RECRUITING

MeSH Terms

Interventions

Lidocaine; Diphenhydramine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethylamines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 4, 2025
• Study Start: September 3, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)