100 Participants Needed

Lidocaine vs Diphenhydramine for Skin Lacerations

Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Florida Atlantic University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the drugs lidocaine and diphenhydramine for treating skin lacerations?

Research shows that both lidocaine and diphenhydramine are effective for numbing the skin during minor laceration repairs, with no significant difference in their ability to reduce pain during suturing. However, lidocaine injections are generally less painful than diphenhydramine injections.12345

Is it safe to use lidocaine or diphenhydramine for skin lacerations?

Both lidocaine and diphenhydramine have been used safely for local anesthesia in skin laceration repairs. Diphenhydramine can be a good alternative for people allergic to lidocaine, and studies show it provides adequate anesthesia without noticeable adverse effects.12356

How does the drug diphenhydramine differ from lidocaine for treating skin lacerations?

Diphenhydramine can be used as an alternative to lidocaine for local anesthesia in patients who are allergic to lidocaine or its chemical relatives. While both drugs are effective for numbing the area, diphenhydramine injections tend to be more painful than lidocaine injections.12345

What is the purpose of this trial?

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.

Eligibility Criteria

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

My cut can be treated by emergency doctors.
I have cuts that needed stitches.

Exclusion Criteria

I am currently bleeding from a cut.
My cut needs to be treated by a specialist.
Patients with allergies to either diphenhydramine or lidocaine
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive either lidocaine or diphenhydramine for local anesthesia during laceration repair

1 day
1 visit (in-person)

Follow-up

Participants are monitored for satisfaction and sensation reduction immediately after the procedure

Immediately after procedure
1 visit (in-person)

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: DiphenhydramineExperimental Treatment1 Intervention
Group II: LidocaineActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Florida Atlantic University

Lead Sponsor

Trials
35
Recruited
10,700+

Baptist Health South Florida

Collaborator

Trials
54
Recruited
8,100+

Findings from Research

Buffered lidocaine with epinephrine and plain lidocaine with epinephrine were found to be more effective anesthetics for suturing minor lacerations compared to buffered lidocaine alone and diphenhydramine with epinephrine, based on evaluations from both patients and physicians.
Diphenhydramine with epinephrine was significantly more painful to inject than buffered lidocaine or buffered lidocaine with epinephrine, indicating it may not be the best choice for pain management in this context.
Comparison trial of four injectable anesthetics for laceration repair.Ernst, AA., Marvez-Valls, E., Nick, TG., et al.[2019]

References

Lidocaine versus diphenhydramine for anesthesia in the repair of minor lacerations. [2019]
1% lidocaine versus 0.5% diphenhydramine for local anesthesia in minor laceration repair. [2019]
Use of diphenhydramine for local anesthesia in "caine"-sensitive patients. [2019]
Comparison trial of four injectable anesthetics for laceration repair. [2019]
Validation of diphenhydramine as a dermal local anesthetic. [2019]
An interesting case of a unilaterally dilated pupil. [2016]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security