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Lidocaine Versus Diphenhydramine to Achieve Local Anesthesia for Laceration Repairs

F

Florida Atlantic University

Status and phase

Enrolling
Phase 3

Conditions

Laceration of Skin

Treatments

Drug: Diphenhydramine
Drug: Lidocaine

Study type

Interventional

Funder types

Other

Identifiers

NCT06910241
2195722

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

100 participants in 2 patient groups

Lidocaine
Active Comparator group
Treatment:
Drug: Lidocaine
Diphenhydramine
Experimental group
Treatment:
Drug: Diphenhydramine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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