Lidocaine Versus Diphenhydramine to Achieve Local Anesthesia for Laceration Repairs

Phase 3RecruitingNCT06910241

Florida Atlantic University100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Laceration of Skin

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

Anesthesia satisfaction by patient

Patient satisfaction of anesthesia yes/no

Time frame: Immediately after laceration repair

Anesthesia satisfaction by physician

Physician satisfaction of anesthesia yes/no