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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00539084
• Other study ID #: NP40
• Status: Completed
• Phase: N/A
• First received: October 2, 2007
• Last updated: May 8, 2013
• Start date: October 2007
• Est. completion date: November 2007

Study information

• Verified date: November 2007
• Source: NanoPass Technologies Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics CommissionIsrael: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intradermal Injections
• Local Anesthesia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NanoPass Technologies Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence and intensity of adverse events		3 Days	No
Primary	Pain scores reported by the subjects following the painful stimulus		one minute after injection	No
Secondary	Feedback from study participants and staff on their overall impression with the MicronJet device, using questionnaires		2 days after injection	No