Lidocaine Versus Diphenhydramine to Achieve Local Anesthesia for Laceration Repairs

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-03

Study Completion Date

2028-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Laceration of Skin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Lidocaine

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

Lidocaine local infiltration

Diphenhydramine

Group Type EXPERIMENTAL

Diphenhydramine

Intervention Type DRUG

Diphenhydramine local infiltration

Interventions

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Lidocaine

Lidocaine local infiltration

Intervention Type DRUG

Diphenhydramine

Diphenhydramine local infiltration

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes