Lidocaine Versus Diphenhydramine to Achieve Local Anesthesia for Laceration Repairs

Phase 3

Not yet recruiting

• Conditions: Laceration of Skin
• Interventions: Drug: Lidocaine; Drug: Diphenhydramine

• Registration Number: NCT06910241
• Lead Sponsor: Florida Atlantic University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-02
• Study First Submitted QC: 2025-04-02
• Study First Posted: 2025-04-04
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-05
• Last Update Posted: 2025-06-06
• Study Start: 2025-07-01
• Primary Completion: 2027-06-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine	Lidocaine	-
Diphenhydramine	Diphenhydramine	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Anesthesia satisfaction by physician	Immediately after laceration repair	Physician satisfaction of anesthesia yes/no
Anesthesia satisfaction by patient	Immediately after laceration repair	Patient satisfaction of anesthesia yes/no

Trial Locations

Locations (1)

Bethesda Hospital East; 🇺🇸 Boynton Beach, Florida, United States