Lidocaine Versus Diphenhydramine to Achieve Local Anesthesia for Laceration Repairs

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06910241

Enrollment

100

Registered

2025-04-04

Start date

2025-09-03

Completion date

2028-06-30

Last updated

2026-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laceration of Skin

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.

Interventions

DRUGLidocaine

Lidocaine local infiltration

DRUGDiphenhydramine

Diphenhydramine local infiltration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Sensation reduction	Measurements will be recorded before drug injection and immediately after laceration repair.	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.

Secondary

Measure	Time frame	Description
Anesthesia satisfaction by patient	Immediately after laceration repair	Patient satisfaction of anesthesia yes/no
Anesthesia satisfaction by physician	Immediately after laceration repair	Physician satisfaction of anesthesia yes/no

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026