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.