Local Anesthesia Clinical Trial
Official title:
A Controlled Comparative Pilot Study to Assess the Safety and Efficacy of the MicronJet Microneedle Device Following Intradermal Injection of Lidocaine for Local Anesthesia
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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