Intradermal Lidocaine Via MicronJet600 Microneedle Device

Summary

The purpose of this study is to determine efficiency and safety of injecting a micro-amount of 2% lidocaine with the commercially available microneedle device MinronJet600 (NanoPass Technologies Ltd, Israel) (registration number RZN2017/5544 by Federal Service for Surveillance in Healthcare of Russian Federation) to achieve rapid local anesthesia for peripheral venous cannulation.

Conditions

• Local Anaesthesia

Interventions

DEVICE

Intravenous cannulation after intradermal injection of lidocaine via MicronJet600 microneedle device (1)

Intradermal administration of 100 µL of lidocaine (registrational number LS001516 by Federal Service for Surveillance in Healthcare of Russian Federation) via MicronJet600 microneedle device at the site of antecubital fossa of the left arm, followed by the insertion of 18G catheter in a cubital vein immediately after the lidocaine administration.

DEVICE

Intravenous cannulation after intradermal injection of saline via MicronJet600 microneedle device

Intradermal administration of 100 µL saline (registration number РN002134/01 by Federal Service for Surveillance in Healthcare of Russian Federation) via MicronJet600 microneedle device at the site of antecubital fossa of the right arm, followed by the insertion of 18G catheter in a cubital vein immediately after the saline administration.

DEVICE

Intravenous cannulation after intradermal injection of lidocaine via MicronJet600 microneedle device (2)

Intradermal administration of 100 µL of lidocaine (registrational number LS001516 by Federal Service for Surveillance in Healthcare of Russian Federation) via MicronJet600 microneedle device at the site of antecubital fossa of the left arm, followed by the insertion of 18G catheter in a cubital vein immediately after the lidocaine administration.

PROCEDURE

Intravenous cannulation after without prior interventions

insertion of 18G catheter in a cubital vein without prior interventions.

Sponsors & Collaborators

• NanoPass Technologies Ltd

  collaborator INDUSTRY

• I.M. Sechenov First Moscow State Medical University

  lead OTHER

Principal Investigators

• Chavdar Dr Pavlov, MD, PhD · I.M. Sechenov First Moscow State Medical University (Sechenov University)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-01-29

Primary Completion

2019-03-15

Completion

2019-03-17

Countries

• Russia

Study Locations