Lidocaine vs Diphenhydramine for Skin Lacerations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Florida Atlantic University

Disqualifiers: Active bleeding, Complex lacerations, Allergies, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

100 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 3 5 6}

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. ^{1 2 3 4 5}

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

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

Group I: Diphenhydramine Experimental Treatment 1 Intervention

Group II: Lidocaine Active Control 1 Intervention

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison trial of four injectable anesthetics for laceration repair. Ernst, AA., Marvez-Valls, E., Nick, TG., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Lidocaine versus diphenhydramine for anesthesia in the repair of minor lacerations. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

1% lidocaine versus 0.5% diphenhydramine for local anesthesia in minor laceration repair. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Use of diphenhydramine for local anesthesia in "caine"-sensitive patients. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Comparison trial of four injectable anesthetics for laceration repair. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Validation of diphenhydramine as a dermal local anesthetic. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

An interesting case of a unilaterally dilated pupil. [2016]