Lidocaine as a diluent for administration of benzathine penicillin G.
J Amir, S Ginat, Y H Cohen...
https://pubmed.ncbi.nlm.nih.gov/9802630Actively Recruiting
Phase 3
Age: 18Years +
All Genders
Healthy Volunteers
ID06391125
LIMIT Trial - Lidocaine With Intramuscular Injection of Benzathine Penicillin G for Treponema Pallidum Treatment
Led by Washington University School of Medicine · Updated on 2025-03-25
48
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding lidocaine to benzathine penicillin G injections can reduce pain for adults being treated for syphilis infections. This randomized, double-blinded, placebo-controlled trial aims to compare pain levels with and without lidocaine added to the injection. The study is motivated by previous evidence showing that lidocaine reduces injection pain, and it addresses the challenge of using lidocaine with prepackaged benzathine penicillin G syringes in the US. Participants will receive two intramuscular injections of benzathine penicillin G, each 1.2 million units, one in each buttock. One injection will include 0.5 ml of 1% lidocaine added to the prefilled syringe, while the other will have 0.5 ml of normal saline solution. The side for each injection is randomly assigned, and both participants and staff administering injections are blinded to which contains lidocaine or saline. Participants will rate their pain on a 0 to 10 scale at 10 minutes after each injection and again at 24 hours via an electronic survey. Researchers will compare pain scores between the two injection types to see if lidocaine reduces pain. They will also monitor for adverse reactions over 7 days and record any use of other pain medications within 24 hours. The study involves screening for allergies and includes adults beginning treatment for syphilis.
CONDITIONS
Brief Title
LIMIT Trial - Lidocaine With Intramuscular Injection of Benzathine Penicillin G for Treponema Pallidum Treatment
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or above
- Confirmed syphilis diagnosis with reactive RPR and confirmatory treponemal testing
- Receiving first injection in series if patient requires 3x weekly injections for syphilis treatment
You will not qualify if you...
- Penicillin allergy causing anaphylaxis
- Lidocaine allergy causing anaphylaxis
- Receiving second or third injection in series if patient requires 3x weekly injections for syphilis treatment
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single day
Participants receive one intramuscular injection of benzathine penicillin G combined with either 0.5 ml 1% lidocaine or 0.5 ml normal saline in each gluteal muscle, to assess pain at 10 minutes and 24 hours post injection.
1 injection visit with pain assessments at 10 minutes and 24 hours post injection
Follow-up
Duration - 7 days
Participants are monitored for adverse reactions and use of other pain medications up to 7 days after injection.
Follow-up contacts within 7 days post injection
Trial Site Locations
Total: 1 location
1
WashU Infectious Diseases Clinic
St Louis, Missouri, United States, 63110
Actively Recruiting
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Research Team
J
Joseph Cherabie, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
2014 European guideline on the management of syphilis.
M Janier, V Hegyi, N Dupin...
https://pubmed.ncbi.nlm.nih.gov/25348878Tolerability of IM penicillin G benzathine diluted or not with local anesthetics, or different gauge needles for syphilis treatment: a randomized clinical trial.
Vicente Estrada, Eva Santiago, Inmaculada Cabezas...
https://pubmed.ncbi.nlm.nih.gov/31646969