Laceration of SkinPhase 3NCT06910241
Lidocaine Versus Diphenhydramine to Achieve Local Anesthesia for Laceration Repairs
A Phase 3 study testing Lidocaine and Diphenhydramine in people with Laceration of Skin, run by Florida Atlantic University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Laceration of Skin
- What is being tested?
- Lidocaine and Diphenhydramine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2025to 30 Jun 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Lacerations requiring one layer of sutures
- Lacerations appropriate for repair by emergency physicians
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Bethesda Hospital East
Boynton Beach, Florida, 33435
Scott M Alter, MD, 561-733-5933, alters@health.fau.edu
About this study
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.
- Conditions
- Laceration of Skin
- Being tested
- Lidocaine, Diphenhydramine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Lidocaine local infiltration
DiphenhydramineDrug
Diphenhydramine local infiltration
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Active comparator | Not described Receives: Drug: Lidocaine |
| Diphenhydramine | Experimental | Not described Receives: Drug: Diphenhydramine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Measurements will be recorded before drug injection and immediately after laceration repair.
Secondary outcomes (2)
Anesthesia satisfaction by patient
Patient satisfaction of anesthesia yes/no
Measured: Immediately after laceration repair
Anesthesia satisfaction by physician
Physician satisfaction of anesthesia yes/no
Measured: Immediately after laceration repair
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start3 Sep 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laceration of SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida Atlantic University
- Sponsor type
- University, hospital or other
- Collaborators
- Baptist Health South Florida
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910241
- Sponsor's protocol ID
- 2195722
- Status last verified
- Jan 2026
- First submitted
- 2 Apr 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lidocaine Versus Diphenhydramine to Achieve Local Anesthesia for Laceration Repairs
- ClinicalTrials.gov ID
- NCT06910241
- Acronym / sponsor ID
- 2195722
- Conditions
- Laceration of Skin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Florida Atlantic UniversityUniversity, hospital or other
- Collaborators
- Baptist Health South Florida
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Active comparator | Drug: Lidocaine |
| Diphenhydramine | Experimental | Drug: Diphenhydramine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Lacerations requiring one layer of sutures
- Lacerations appropriate for repair by emergency physicians
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LidocaineLidocaine local infiltration | Drug | Lidocaine |
| DiphenhydramineDiphenhydramine local infiltration | Drug | Diphenhydramine |
Primary outcome
Sensation reduction
Time frame: Measurements will be recorded before drug injection and immediately after laceration repair.
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.
2 secondary outcomes
Anesthesia satisfaction by patient
Time frame: Immediately after laceration repair
Anesthesia satisfaction by physician
Time frame: Immediately after laceration repair
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lidocaine and Diphenhydramine in people with Laceration of Skin, run by Florida Atlantic University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensation reduction (time frame: Measurements will be recorded before drug injection and immediately after laceration repair.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.