Clinical trial NCT01674075: Lidocaine Serum Levels in Healthy Adult Volunteers: a Pilot Evaluation of the J-Tip Delivery System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: safety
J-Tip Delivery System
pharmacokinetic profile
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-08-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers over the age of 18.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Serum lidocaine concentrations
timeFrame: 1 hour post J-Tip administration
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Padma Gulur, MD
role: PRINCIPAL_INVESTIGATOR
References: