Clinical trial NCT00539084: A Study to Assess the Safety and Efficacy of a Microneedle Device for Local Anesthesia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Local Anesthesia
Intradermal Injections
Keywords: microneedles
microneedle
intradermal
Lead sponsor: NanoPass Technologies Ltd
Sponsor class: INDUSTRY
First posted: 2007-10-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Healthy males and females. a signed informed consent.
* No significant abnormalities in screening physical exam.
* No significant abnormalities in clinical laboratory parameters.
* No significant abnormalities in ECG within 21 days of the start of the study.
* Intact skin at the sites of injection.
* Accessible veins in the antecubital area.

Exclusion Criteria:

* Hypersensitivity to local anaesthetics.
* History of previous vasovagal events.
* Presence of tattoos, discoloration, acne, scars, keloids or any other marks, bruises cuts or abrasions at the injection sites.
* Subjects with active or chronic skin disease or systemic disease with significant skin involvement.
* History of skin allergy or hypersensitivity.
* History of easy bruising.
* Current or previous history of neurological disorders (particularly neuropathies).
* A history of drug or alcohol abuse.
* Acute infection within 7 days prior to study day.
* Subjects who participated in a clinical study within 4 weeks prior to study day, or who plan to participate in another clinical trial during the time of the trial.
* Subjects suffering from Behçet's disease.
* Pregnant or lactating women.
* Any contraindication (relative or absolute) to study drug.

Primary outcomes:
measure: Prevalence and intensity of adverse events
timeFrame: 3 Days
measure: Pain scores reported by the subjects following the painful stimulus
timeFrame: one minute after injection
Secondary outcomes:
measure: Feedback from study participants and staff on their overall impression with the MicronJet device, using questionnaires
timeFrame: 2 days after injection
Other outcomes:
Locations:
Study officials:
affiliation: Head of the unit for Clinical Research at the Sourasky Medical Center, Tel Aviv, Israel
name: Jacob Atsmon, MD
role: PRINCIPAL_INVESTIGATOR
References: