Lidocaine Serum Levels in Healthy Adult Volunteers: a Pilot Evaluation of the J-Tip Delivery System

Completed

• Conditions: Healthy

• Registration Number: NCT01674075
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-23
• Study First Submitted QC: 2012-08-27
• Study First Posted: 2012-08-28
• Study Start: 2012-09
• Primary Completion: 2013-02
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-10
• Last Update Posted: 2013-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum lidocaine concentrations	1 hour post J-Tip administration	To evaluate the safety and pharmacokinetics of the J-Tip Delivery system by measuring serum lidocaine concentrations in healthy adult volunteers.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States