Lidocaine Serum Levels in Healthy Adult Volunteers: a Pilot Evaluation of the J-Tip Delivery System
The J-Tip device (National Medical Products, Irvine, CA, USA) is a single-use, needle-free anesthesia delivery system, approximately 10cm long and weighing 9g that allow for the rapid delivery of lidocaine hydrochloride prior to peripheral venous access procedures. First introduced in 2001, it uses compressed carbon dioxide for drug delivery into the subcutaneous space. J-Tip is now approved by the U.S. Food and Drug Administration (FDA) for both children and adults.
Designed for patients with needle anxiety and phobia, several clinical trials (Hollingsworth et al, 2000; Cooper JA et al, 2000) have shown the device to be effective with no significant untoward effects, including in children as young as 3 years old (Zempsky et al, 2008). However, two recent cases of toxic serum lidocaine levels in pediatric patients at Massachusetts General Hospital (MGH) following the use of the J-Tip device is concerning. Both patients were administered local anesthetic using the J-Tip device prior to needle-stick and toxicity screens returned with high levels of lidocaine (>6000 mcg/L).
Currently, there is a limited amount of literature available on the safety profile of the J-Tip Delivery System and no study to date has evaluated serum lidocaine levels following its use, likely on the assumption that systemic absorption from the small amount of lidocaine within the device should be negligible. The two pediatric cases highlighted above, seem to suggest otherwise. The purpose of this pilot study is to assess the safety of the J-Tip device on a small population of healthy adults and to determine if elevated lidocaine levels are present systemically or locally. The primary outcome will be lidocaine serum levels following the administration of the J-Tip device measured at the local site and two distal sites to establish lidocaine serum levels following J-Tip administration. We expect lidocaine levels to be undetectable.
研究概览
地位
条件
研究类型
注册 (实际的)
联系人和位置
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02114
- Massachusetts General Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria-
- Adults (18-59 years old) without known medical illness
- Subject has capacity to provide informed consent
Exclusion Criteria-
- Individuals who have recently received "caine" (dental procedures, topical (orajel) or hydrocortisone/lidocaine cream) will be excluded from the study
- History of liver or kidney problems
- Individuals receiving chemotherapeutic agents
- Individuals with the PORT-A-CATH® Implantable Vascular Access System
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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Healthy adult volunteers
Healthy adult volunteers will be administered a J-Tip to the dorsum of his/her hand.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Serum lidocaine concentrations
大体时间:1 hour post J-Tip administration
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To evaluate the safety and pharmacokinetics of the J-Tip Delivery system by measuring serum lidocaine concentrations in healthy adult volunteers.
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1 hour post J-Tip administration
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合作者和调查者
调查人员
- 首席研究员:Padma Gulur, MD、Massachusetts General Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 2012P001141
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