NCT00539084

A Study to Assess the Safety and Efficacy of a Microneedle Device for Local Anesthesia

A Controlled Comparative Pilot Study to Assess the Safety and Efficacy of the MicronJet Microneedle Device Following Intradermal Injection of Lidocaine for Local Anesthesia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: NanoPass Technologies Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine whether the MicronJet microneedle device is effective for inducing rapid and painless local anesthesia prior to insertions of intravenous catheters.

Detailed description

Local anesthesia is routinely administered to reduce patient discomfort and improve the outcome of a wide variety of painful medical procedures. However, injection of a local anesthetic agent into the skin using a regular needle is in itself painful. Therefore, common procedures involving needle pricks (e.g. venipuncture) which may be quite painful are usually performed without local anesthesia. NanoPass has developed a microneedle injection device (MicronJet) which enables painless delivery of drugs directly into the superficial layers of the skin. The objective of the study is to assess the safety and efficacy of this device for intradermal injection of a local anesthetic agent before insertion of an intravenous catheter to healthy adults. Each subject will receive an injection of a local anesthetic to one arm, and a control placebo injection of physiological water to the other arm. Both injections will be administered intradermally using the MicronJet. Following the injections, an intravenous catheter will be inserted into the injection site in each arm, and the subject will rate the pain caused by the insertion. Safety parameters will be recorded throughout the study.

Conditions

• Local Anesthesia
• Intradermal Injections

Interventions

Type	Name	Description
DEVICE	MicronJet	The MicronJet is a microneedle injection device designed for intradermal delivery of drugs (i.e. delivery into the layers of the skin). In this study the MicronJet will be used to inject Lidocaine or Saline.

Timeline

• Start date: 2007-10-01
• Primary completion: 2007-10-01
• Completion: 2007-11-01
• First posted: 2007-10-03
• Last updated: 2013-05-10