What this study is
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.
What's being tested
- Lidocaine
Intervention · DRUG
Lidocaine local infiltration
- Diphenhydramine
Intervention · DRUG
Diphenhydramine local infiltration
Study details
- Sponsor
- Florida Atlantic University
- Conditions
- Laceration of Skin
- Enrolling
- 100 people
- Starts
- 2025-09-03
- Est. completion
- 2028-06-30
- Design
- Double-blind, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers AcceptedYou may qualify if
- Lacerations requiring one layer of sutures
- Lacerations appropriate for repair by emergency physicians
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openBethesda Hospital East
Boynton Beach, Florida, United States
- Scott M Alter, MD · Contact561-733-5933alters@health.fau.edu
Recruiting
Study team
Sponsor
Florida Atlantic University
Study ID 2195722
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.