Lidocaine vs Diphenhydramine for Skin Lacerations
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines whether diphenhydramine (an antihistamine) is as effective as lidocaine (a local anesthetic) for numbing small skin cuts that require stitches. Although lidocaine is the standard choice, diphenhydramine might serve as a viable alternative. The trial will compare the pain experienced during and after stitching with each treatment. It is suitable for individuals with simple cuts needing one layer of stitches, treatable by emergency room doctors. Those with allergies to these medications or with more complex cuts are not eligible. As a Phase 3 trial, it represents the final step before FDA approval, allowing participants to potentially expand treatment options.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that diphenhydramine can be safely injected under the skin. However, some people report skin issues at the injection site, such as skin damage, and the injection can be painful. It may also cause drowsiness afterward. Studies indicate that diphenhydramine numbs small cuts as effectively as lidocaine, but it might be more painful when injected.
Lidocaine, in contrast, is commonly used for numbing during many procedures and is generally well-tolerated. It effectively relieves pain and is safely used for treating open wounds. However, in rare cases, it can cause serious side effects, such as acute toxicity, which can be dangerous.
Both treatments have been used before, but each has pros and cons regarding safety. These details are important to consider when deciding to join a clinical trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they offer potential alternatives to standard care for skin lacerations, which typically involves lidocaine as a local anesthetic. Diphenhydramine, commonly known as an antihistamine, is being explored for its anesthetic properties, which is quite different from its usual use for allergies. This alternative approach could provide pain relief for individuals who may have allergies or sensitivities to lidocaine, expanding options for patient care. Additionally, a new mechanism of action in using diphenhydramine for pain relief could lead to innovative methods in treating minor injuries.
What evidence suggests that this trial's treatments could be effective for skin lacerations?
This trial will compare the effectiveness of lidocaine and diphenhydramine for treating skin lacerations. Research has shown that lidocaine, a well-known local anesthetic, effectively relieves pain during procedures for simple cuts. Diphenhydramine, commonly used for allergies, has also been studied for its potential as a local anesthetic. One study found that 1% diphenhydramine and 1% lidocaine provided similar pain relief for up to 30 minutes after injection. However, diphenhydramine showed differences in effectiveness between 45 to 60 minutes and caused skin damage (tissue death) in one case. While lidocaine remains a reliable choice, diphenhydramine could serve as an alternative, but further research is needed to understand its long-term safety and effectiveness.678910
Are You a Good Fit for This Trial?
This trial is for individuals who come to the emergency department with simple lacerations that need only one layer of sutures and can be treated by emergency physicians. It's not suitable for those with complex wounds, active bleeding, allergies to lidocaine or diphenhydramine, or if their repair would benefit from epinephrine.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either lidocaine or diphenhydramine for local anesthesia during laceration repair
Follow-up
Participants are monitored for satisfaction and sensation reduction immediately after the procedure
What Are the Treatments Tested in This Trial?
Interventions
- Diphenhydramine
- Lidocaine
Trial Overview
The study compares two local anesthetics: Lidocaine and Diphenhydramine. Patients will receive one of these drugs before their laceration is sutured. The goal is to see if Diphenhydramine's effectiveness in numbing pain is as good as Lidocaine's during the procedure.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
Florida Atlantic University
Lead Sponsor
Baptist Health South Florida
Collaborator
Published Research Related to This Trial
Citations
Double-blinded comparison of diphenhydramine versus ...
Results: No significant differences in mean pinprick sensation were seen from baseline to 30 minutes. Significant differences were seen at 45 (P = .036) and 60 ...
2.
qscience.com
qscience.com/content/journals/10.5339/jemtac.2025.15?crawler=true&mimetype=application/pdfComparison of different delivery methods of lidocaine and ...
The same study also reported that diphenhydramine caused skin necrosis in one subject, a side effect that was not observed with lidocaine.
Lidocaine versus diphenhydramine for anesthesia in the ...
This prospective study compared the effectiveness of 1% diphenhydramine with 1% lidocaine for local anesthesia in repair of minor skin lacerations in adults ...
Rationale for the topical use of a combination ...
Combination of antihistamines and fast-acting analgesics may help to reduce discomfort associated with cutaneous reactions. Aim. To evaluate efficacy and safety ...
1% Lidocaine Versus 0.5% Diphenhydramine for Local ...
The data were analyzed after 98 lacerations were included in the study. Fifty patients received 0.5% diphenhydramine, and 48 received 1% lidocaine. Two patients ...
Safe Use of Subcutaneous Diphenhydramine in the ...
This retrospective review demonstrates that subcutaneous diphenhydramine injection is a safe alternative to oral and other parenteral routes.
Safety and technical success of diphenhydramine as an ...
Potential reported disadvantages of DPH include skin necrosis at the injection site, painful administration, and drowsiness. 17. Bartfield ...
Diphenhydramine - StatPearls - NCBI Bookshelf - NIH
However, limited data on its safety and dosing in ESKD are available. High protein binding may hinder its removal during dialysis, raising ...
Use of diphenhydramine for local anesthesia in “caine”
One subject developed skin necrosis at the injection site with diphenhydramine. The duration of local anesthesia for 1% lidocaine was significantly longer and ...
1% Lidocaine Versus 0.5% Diphenhydramine for Local ...
1% diphenhydramine is as effective as 1% lidocaine for anesthesia in minor laceration repair, but that it also is more painful to inject.
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