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

NCT01674075 | Completed

• 1 other identifier: 2012P001141
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

safety; J-Tip Delivery System; pharmacokinetic profile

Outcome Measures

Primary Outcomes (1)

• Serum lidocaine concentrations

  To evaluate the safety and pharmacokinetics of the J-Tip Delivery system by measuring serum lidocaine concentrations in healthy adult volunteers.

  1 hour post J-Tip administration

Study Arms (1)

Healthy adult volunteers

Healthy adult volunteers will be administered a J-Tip to the dorsum of his/her hand.

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers over the age of 18.

You may qualify if:

• Adults (18-59 years old) without known medical illness
• Subject has capacity to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Study Officials

• Padma Gulur, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Inpatient Pain Services

Study Record Dates

• First Submitted: August 23, 2012
• First Posted: August 28, 2012
• Study Start: September 1, 2012
• Primary Completion: February 1, 2013
• Last Updated: July 11, 2013

Record last verified: 2013-07

Locations

US (1)