LIMIT Trial - Lidocaine With Intramuscular Injection of Benzathine Penicillin G for Treponema Pallidum Treatment
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Mean Pain Score (0-10) of Benzathine Penicillin G + Saline Injection 10 minutes post injection
研究概览
简要总结
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 propose a randomized controlled trial of benzathine penicillin G with and without lidocaine to quantify any site pain reduction with lidocaine in patients being treated for syphilis.
This study is a randomized, double blinded, placebo controlled trial. During this study, patients needing BPG treatment for syphilis will be screened for any penicillin allergies and consented to their participation. Each participant will receive 2 injections of BPG, 1.2 million units each (2x1.2 million units = 2.4 million units, the standard dose for syphilis treatment), as intramuscular injections, one in each gluteal muscle, with one of the injections randomly having 0.5ml of 1% lidocaine added while the other has 0.5 ml normal saline solution. The side of each injection will be randomized by the medical assistant (MA)/nurse filling the vials and the injecting MA will be blinded, as well as the study participant, as to which vial contains lidocaine and which contains normal saline. The participants will then be asked to rate their pain from 0-10 on each site of injection at 10 minutes post injection, then again at 24 hours after injection via email electronic survey (via RedCap). The differences in pain from the two injections will be compared and analyzed to see if lidocaine reduces pain associated with BPG injections compared to the control of normal saline added to BPG.
详细描述
The purpose of the study is to test the question of: Does the addition of 0.5ml 1% lidocaine compared to 0.5 ml normal saline solution to 1.2 million units of benzathine penicillin G affect the pain experienced by individuals being treated for Treponema pallidum (syphilis) infections at 10 minutes and 24 hours post injection?
Background
Prior Literature and Studies, and Rationale for this Study
There is evidence to suggest that lidocaine can help reduce the pain associated with intramuscular injections of benzathine penicillin G or bicillin, used to treat syphilis infections. A study published in the Journal of Pediatric Infectious Diseases in 1998 found that the use of lidocaine as a diluent of BPG significantly reduced the pain of injection. Another study by Estrada et al in 2019 looked at the addition of 1% mepivicaine as diluent for PGB vs PGB alone and showed that mepivicaine significantly decreased pain experienced by participants. Per the IUSTI European Guidelines for Syphilis management, lidocaine is used as a diluent for benzathine penicillin G since 1998. No studies have been performed thus far looking at prefilled benzathine penicillin G syringes and the possibility of inserting lidocaine to the injection to decrease the pain experienced by individuals being treated for syphilis infections, instead of using lidocaine as a diluent which is not possible for the BPG formulations present here in the US.
Study Objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Both participants and clinicians will be blinded to the contents of the syringe. The nurse filling the syringe will assign the syringes randomly to be injected into L or R gluteal muscle and will label them accordingly, logging the designation in a log book that will remain blinded until the analysis portion of the study. The participant will be blinded as they will receive one site of injection with lidocaine and the other with normal saline, serving as their own intervention and control group.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Penicillin allergy (anaphylaxis)
- •Lidocaine allergy (anaphylaxis)
- •Second or third injection in series if patient requires 3x weekly injections for syphilis treatment
- •Pregnancy
研究组 & 干预措施
Lidocaine + Benzathine Penicillin G Arm
0.5ml 1% lidocaine solution added to prefilled 1.2 million units Benzathine Pencillin G syringe which will be injected once into the gluteal muscle of the study participant, the side (left or right) to be randomly assigned with the control assigned to the other gluteal muscle.
干预措施: Lidocaine (Drug)
Normal Saline + Benzthine Penicillin G Arm
0.5ml normal saline solution added to prefilled 1.2 million units Benzathine Pencillin G syringe which will be injected once into the gluteal muscle of the study participant, the side (left or right) to be randomly assigned with the study arm assigned to the other gluteal muscle.
干预措施: normal Saline (Drug)
结局指标
主要结局
Mean Pain Score (0-10) of Benzathine Penicillin G + Saline Injection 10 minutes post injection
时间窗: 10 minutes
The average rating of participants' injection site pain with added lidocaine from 0 (no pain) to 10 (extreme pain) at 10 minutes post injection
Mean Pain Score (0-10) of Benzathine Penicillin G + Saline Injection 24 hours post injection
时间窗: 24 hours
The average rating of participants' injection site pain with added lidocaine from 0 (no pain) to 10 (extreme pain) at 24 hours post injection
Relative difference of mean pain scores between injection types 10 minutes post injection
时间窗: 10 minutes
Comparative t-test of means of pain scores at injections sites at 10 minutes post injection
Mean Pain Score (0-10) of Benzathine Penicillin G + Lidocaine Injection 24 hours post injection
时间窗: 24 hours
The average rating of participants' injection site pain with added lidocaine from 0 (no pain) to 10 (extreme pain) at 24 hourspost injection
Relative difference of mean pain scores between injection types at 24 hours post injection
时间窗: 24 hours
Comparative t-test of means of pain scores at injections sites at 24 hours post injection
Mean Pain Score (0-10) of Benzathine Penicillin G + Lidocaine Injection 10 minutes post injection
时间窗: 10 minutes
The average rating of participants' injection site pain with added lidocaine from 0 (no pain) to 10 (extreme pain) at 10 minutes post injection
次要结局
- Rate of Adverse reactions(7 days)
- Rate of Use of other pain medications(24 hours)
研究者
Joseph Cherabie
Assistant Professor
Washington University School of Medicine