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NCT01674075 · ClinicalTrials.gov registry record
Lidocaine Serum Levels in Healthy Adult Volunteers: a Pilot Evaluation of the J-Tip Delivery System
A clinical trial, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- 10
- Enrollment target
NCT01674075: Completed study, sponsored by Massachusetts General Hospital.
NCT01674075 is a clinical trial that has completed, run by Massachusetts General Hospital. The registered enrollment target is 10 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01674075 has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- 10 participants
- Enrollment target
Study 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.
Primary Outcome
To evaluate the safety and pharmacokinetics of the J-Tip Delivery system by measuring serum lidocaine concentrations in healthy adult volunteers.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2012-09 |
What the finished NCT01674075 record still lists
NCT01674075 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 10 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01674075 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01674075 about?
NCT01674075 is a clinical study titled "Lidocaine Serum Levels in Healthy Adult Volunteers: a Pilot Evaluation of the J-Tip Delivery System". 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 ...
What is the current status of trial NCT01674075?
This trial is currently completed. The enrollment target is 10 participants. The study started on 2012-09.
Who is sponsoring clinical trial NCT01674075?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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