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Recruiting NCT06910241

Lidocaine Versus Diphenhydramine to Achieve Local Anesthesia for Laceration Repairs

Phase III Interventional Laceration of Skin

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lidocaine, Diphenhydramine.
Who it may be relevant to
Registry conditions: Laceration of Skin. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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.

Interventions

  • Drug Lidocaine
    Lidocaine local infiltration
  • Drug Diphenhydramine
    Diphenhydramine local infiltration

Primary outcome measures

  • Sensation reduction [Time frame: Measurements will be recorded before drug injection and immediately after laceration repair.]
Secondary outcome measures (2)
  • Anesthesia satisfaction by patient [Time frame: Immediately after laceration repair]
  • Anesthesia satisfaction by physician [Time frame: Immediately after laceration repair]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Bethesda Hospital East — Boynton Beach

Identifiers

NCT: NCT06910241 · 2195722

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗