Health TrialsbyHealthPanel

Lidocaine Versus Diphenhydramine to Achieve Local Anesthesia for Laceration Repairs

ConditionLaceration of Skin
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorFlorida Atlantic University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Lacerations requiring one layer of sutures

Lacerations appropriate for repair by emergency physicians

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lidocaine

    Drug

    Lidocaine local infiltration

  • Diphenhydramine

    Drug

    Diphenhydramine local infiltration

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: LidocaineActive comparator 1 intervention
Group B: DiphenhydramineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

1

Anesthesia satisfaction by patient

Patient satisfaction of anesthesia yes/no

Time frame
Immediately after laceration repair
2

Anesthesia satisfaction by physician

Physician satisfaction of anesthesia yes/no

Time frame
Immediately after laceration repair

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Florida Atlantic University

Lead sponsor

Baptist Health South Florida

Collaborator

Source ClinicalTrials.gov
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