Intradermal Lidocaine Via MicronJet600 Microneedle Device
Condition: Local Anaesthesia
Study type: Interventional

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.
    

Detailed description: 
      The trial is prospective, randomised, open-label, placebo-controlled. The start date of
      patient enrolment was January 29 of 2019. Simple randomization was performed to allocate
      subjects into two groups using the Microsoft Excel random number generator. As a result of
      randomisation, subjects were allocated into two groups - Group1 and Group2.

      In this study, each subject from Group1 received injection of local anaesthetic into the left
      arm and sterile saline as a placebo into the right arm, the injections were performed with
      MicronJet600 and followed by the intravenous cannulation; each subject from Group2 will
      receive injection of local anaesthetic into the left arm, which was performed with
      MicronJet600 and followed by the intravenous cannulation, with no pre-treatment prior to the
      intravenous cannulation in case of the right arm. Pain caused by the cannulations was rated
      by the subjects in accordance with 100-point visual analogue scale. Safety parameters was
      assessed throughout the study.
    

Intervention name(s): Intravenous cannulation after intradermal injection of lidocaine via MicronJet600 microneedle device (1); Intravenous cannulation after intradermal injection of saline via MicronJet600 microneedle device; Intravenous cannulation after intradermal injection of lidocaine via MicronJet600 microneedle device (2); Intravenous cannulation after without prior interventions
Intervention type(s): Device; Device; Device; Procedure
Intervention description(s): 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.; 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.; 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.; insertion of 18G catheter in a cubital vein without prior interventions.
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Microneedles, local anaesthesia, intradermal administration