Using lidocaine to reduce pain from benzathine penicillin injections for syphilis treatment
LIMIT Trial - Lidocaine With Intramuscular Injection of Benzathine Penicillin G for Treponema Pallidum Treatment
This study is testing if adding lidocaine to syphilis treatment injections can help reduce the pain patients feel during and after the shot.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT06391125 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate whether the addition of lidocaine to benzathine penicillin G injections can reduce the pain experienced by patients being treated for syphilis infections. Participants will receive either benzathine penicillin G with lidocaine or with normal saline, and their pain levels will be assessed at 10 minutes and 24 hours post-injection. The study is designed as a randomized controlled trial to provide robust evidence on the efficacy of lidocaine in this context. The trial is particularly relevant given the challenges of using lidocaine as a diluent in the US compared to European practices.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of syphilis who are receiving their first injection in a treatment series.
Not a fit: Patients with allergies to penicillin or lidocaine, or those who are pregnant, will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the comfort of patients receiving treatment for syphilis.
How similar studies have performed: Previous studies have shown that lidocaine can effectively reduce injection pain, suggesting a positive outlook for this trial's approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults 18 years of age or above * Confirmed syphilis diagnosis (reactive RPR with confirmatory treponemal testing) * Receiving first injection in series if patient requires 3x weekly injections for syphilis treatment Exclusion Criteria: * Penicillin allergy (anaphylaxis) * Lidocaine allergy (anaphylaxis) * Second or third injection in series if patient requires 3x weekly injections for syphilis treatment * Pregnancy
Where this trial is running
St Louis, Missouri
- WashU Infectious Diseases Clinic — St Louis, Missouri, United States (Recruiting)
Study contacts
- Study coordinator: Joseph Cherabie, MD
- Email: jcherabie@wustl.edu
- Phone: 7202858096
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.