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LIMIT Trial - Lidocaine With Intramuscular Injection of Benzathine Penicillin G for Treponema Pallidum Treatment

RecruitingPhase 3Ages 18 Years - anyAllWashington University School of Medicine
NCT06391125 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

There is evidence to suggest that lidocaine can help reduce the pain associated with intramuscular injections of benzathine penicillin G (BPG) or Bicillin, used to treat syphilis infections. A study published in the Journal of Family Practice in 2001 compared the pain experienced during bicillin injections with and without the use of lidocaine. The study found that patients who received lidocaine injections before receiving bicillin reported significantly less pain compared to those who received bicillin injections without lidocaine. Per the International Union against Sexually Transmitted Infections (IUSTI) European Guidelines for syphilis management, lidocaine has been used as a diluent for BPG since 1998. In the United States (US), BPG often comes prepackaged and lidocaine is unable to be used as a diluent with the same ease as it is in Europe. In light of this, the investigators prop

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📋 Eligibility rules (as published)
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
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What it tests

  • normal Saline
  • Lidocaine
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Where

1 site
WashU Infectious Diseases Clinic
St Louis, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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