Lidocaine Versus Diphenhydramine to Achieve Local Anesthesia for Laceration Repairs
Part of paid clinical trials in Boynton Beach, Florida.
- Sponsor
- Florida Atlantic University
- Study ID
- NCT06910241
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- Laceration of Skin
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Lidocaine — DRUGLidocaine local infiltration
- Diphenhydramine — DRUGDiphenhydramine local infiltration
Study Details
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.
Key Dates
- Start date
- Sep 3, 2025
- Status verified
- Jan 2026
- Primary completion
- Jun 30, 2027
- Completion
- Jun 30, 2028
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Lidocaine
- Experimental: Diphenhydramine
Primary Outcome Measure
Sensation reduction [ Time Frame: Measurements will be recorded before drug injection and immediately after laceration repair. ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Bethesda Hospital East | Boynton Beach | Florida | 33435 |
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