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NCT Number: NCT06910241

Lidocaine Versus Diphenhydramine to Achieve Local Anesthesia for Laceration Repairs

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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Key information

Conditions

Laceration of Skin

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bethesda Hospital East

Boynton Beach, Florida, 33435, United States

Location status: Recruiting

Location contact

Scott M Alter, MD

CONTACT

[email protected]

561-733-5933

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine

Drug

Lidocaine local infiltration

diphenhydramine

Drug

Diphenhydramine local infiltration

Primary outcomes

  1. Sensation reduction

    Time frame: 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 outcomes

  1. Anesthesia satisfaction by patient

    Time frame: Immediately after laceration repair

    Patient satisfaction of anesthesia yes/no

  2. Anesthesia satisfaction by physician

    Time frame: Immediately after laceration repair

    Physician satisfaction of anesthesia yes/no

Sponsors and collaborators

Lead sponsor

Florida Atlantic University

Other

Collaborators

  • Baptist Health South Florida

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Apr 4, 2025
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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