Lidocaine versus diphenhydramine for numbing simple skin lacerations
Lidocaine Versus Diphenhydramine to Achieve Local Anesthesia for Laceration Repairs
This study will see if injected diphenhydramine numbs simple lacerations as well as 1% lidocaine for people who need stitches in the emergency department.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Florida Atlantic University Academic / other |
| Locations | 1 site (Boynton Beach, Florida) |
| Trial ID | NCT06910241 on ClinicalTrials.gov |
What this trial studies
Adults presenting to the emergency department with simple skin lacerations that require a single-layer suture and are appropriate for repair by emergency physicians will be enrolled. Participants will receive local infiltration with either diphenhydramine or 1% lidocaine and pain scores for the injection and the repair procedure will be recorded. The study is designed as a noninferiority comparison to determine whether diphenhydramine provides similar anesthesia to lidocaine for bedside laceration repair. Patients with active bleeding, complex lacerations, allergies to the study drugs, or cases where epinephrine would be beneficial are excluded.
Who should consider this trial
Good fit: Ideal candidates are people who present to the emergency department with simple lacerations that need one-layer suturing and can be repaired by emergency physicians.
Not a fit: Patients with active bleeding, complex or multi-layer lacerations, those needing specialist repair, those allergic to diphenhydramine or lidocaine, or those who would benefit from epinephrine are unlikely to benefit from this study.
Why it matters
Potential benefit: If diphenhydramine is noninferior to lidocaine, it could offer an alternative local anesthetic option when lidocaine is contraindicated or unavailable.
How similar studies have performed: Small studies and case reports have shown local diphenhydramine can produce anesthesia for minor procedures, but direct, high-quality comparisons to lidocaine are limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boynton Beach, Florida
- Bethesda Hospital East — Boynton Beach, Florida, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.