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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Padma Gulur, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01674075
First received: August 23, 2012
Last updated: July 10, 2013
Last verified: July 2013

August 23, 2012
July 10, 2013
September 2012
February 2013   (final data collection date for primary outcome measure)
Serum lidocaine concentrations [ Time Frame: 1 hour post J-Tip administration ] [ Designated as safety issue: Yes ]
To evaluate the safety and pharmacokinetics of the J-Tip Delivery system by measuring serum lidocaine concentrations in healthy adult volunteers.
Serum lidocaine concentrations [ Designated as safety issue: Yes ]
To evaluate the safety and pharmacokinetics of the J-Tip Delivery system by measuring serum lidocaine concentrations in healthy adult volunteers.
Complete list of historical versions of study NCT01674075 on ClinicalTrials.gov Archive Site
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Lidocaine Serum Levels in Healthy Adult Volunteers: a Pilot Evaluation of the J-Tip Delivery System
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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.

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Healthy volunteers over the age of 18.

Healthy
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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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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
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February 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 59 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01674075
2012P001141
No
Padma Gulur, MD, Massachusetts General Hospital
Massachusetts General Hospital
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Principal Investigator: Padma Gulur, MD Massachusetts General Hospital
Massachusetts General Hospital
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP