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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01674075
Recruitment Status : Completed
First Posted : August 28, 2012
Last Update Posted : July 11, 2013
Information provided by (Responsible Party):
Padma Gulur, MD, 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.

Condition or disease

Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : September 2012
Actual Primary Completion Date : February 2013

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

Primary Outcome Measures :
  1. Serum lidocaine concentrations [ Time Frame: 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy volunteers over the age of 18.

Inclusion Criteria-

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

Exclusion Criteria-

  1. Individuals who have recently received "caine" (dental procedures, topical (orajel) or hydrocortisone/lidocaine cream) will be excluded from the study
  2. History of liver or kidney problems
  3. Individuals receiving chemotherapeutic agents
  4. Individuals with the PORT-A-CATH® Implantable Vascular Access System

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01674075

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Padma Gulur, MD Massachusetts General Hospital

Responsible Party: Padma Gulur, MD, Director of Inpatient Pain Services, Massachusetts General Hospital Identifier: NCT01674075     History of Changes
Other Study ID Numbers: 2012P001141
First Posted: August 28, 2012    Key Record Dates
Last Update Posted: July 11, 2013
Last Verified: July 2013

Keywords provided by Padma Gulur, MD, Massachusetts General Hospital:
J-Tip Delivery System
pharmacokinetic profile