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| Name | Class |
|---|---|
| NanoPass Technologies Ltd | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1. Left arm. | Experimental | Healthy subjects, who underwent the following intervention: intradermal injection of lidocaine hydrochloride injectable solution 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. |
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| Group 1. Right arm. | Placebo Comparator | Healthy subjects, who underwent the following intervention: intradermal injection of sterile saline 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. |
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| Group 2. Left arm. | Experimental | Healthy subjects, who underwent the following intervention: intradermal injection of lidocaine hydrochloride injectable solution 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. |
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| Group 2. Right arm. | Active Comparator | Healthy subjects, who underwent the following intervention: insertion of 18G catheter in a cubital vein at the site of antecubital fossa of the right arm, without any prior intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous cannulation after intradermal injection of lidocaine via MicronJet600 microneedle device (1) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain scores, reported by the subjects due to painful stimulus by intravenous catheterisation with 18G cannula | Pain scores experienced by the subjects due to intravenous catheterisation with 18G cannula. were recorded by using a 100-point visual analogue scale. | Immediately after intravenous catheterisation with 18G cannula. |
| Pain scores, reported by the subjects due to painful stimulus due to a pin-prick with a 27G needle (1) | Pain scores experienced by the subjects due to a pin-prick with a 27G needle at 1, 2 and 3 centimetres from the site of intradermal lidocaine injection were recorded by using a 100-point visual analogue scale. | At 15 minutes after the intradermal lidocaine injection. |
| Pain scores, reported by the subjects due to painful stimulus due to a pin-prick with a 27G needle (2) | Pain scores experienced by the subjects due to a pin-prick with a 27G needle at 1, 2 and 3 centimetres from the site of intradermal lidocaine injection were recorded by using a 100-point visual analogue scale. | At 30 minutes minutes after the intradermal lidocaine injection. |
| Pain scores, reported by the subjects due to painful stimulus due to a pin-prick with a 27G needle (3) | Pain scores experienced by the subjects due to a pin-prick with a 27G needle at 1, 2 and 3 centimetres from the site of intradermal lidocaine injection were recorded by using a 100-point visual analogue scale. | At 45 minutes after the intradermal lidocaine injection. |
| Prevalence of adverse events. | Any kind of local and systemic adverse events were recorded after the lidocaine injection with MicronJet600 followed by the intravenous cannulation. | 24 hours after the lidocaine injection with MicronJet600. |
| Measure | Description | Time Frame |
|---|---|---|
| Preference to receive injection of lidocaine with MicronJet600 prior to intravenous cannulation, over the cannulation without any pre-treatment. | Preference to receive injection of lidocaine with MicronJet600 before intravenous cannulation over the cannulation without any pre-treatment in subjects of Group2. The preference was recorded with the 5-point Likert scale. | Immediately after the intravenous catheterisation with 18G cannula. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chavdar Dr Pavlov, MD, PhD | I.M. Sechenov First Moscow State Medical University (Sechenov University) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Clinical Hospital №2 (I.M. Sechenov First Moscow State Medical University (Sechenov University)) | Moscow | 119435 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35100279 | Derived | Rzhevskiy A, Popov A, Pavlov C, Anissimov Y, Zvyagin A, Levin Y, Kochba E. Intradermal injection of lidocaine with a microneedle device to provide rapid local anaesthesia for peripheral intravenous cannulation: A randomised open-label placebo-controlled clinical trial. PLoS One. 2022 Jan 31;17(1):e0261641. doi: 10.1371/journal.pone.0261641. eCollection 2022. |
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The local ethics committee of the Sechenov University does not allow to share IPD; it is possible only upon an official request addressed to the principal investigator.
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| Intravenous cannulation after intradermal injection of saline via MicronJet600 microneedle device | 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. |
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| Intravenous cannulation after intradermal injection of lidocaine via MicronJet600 microneedle device (2) | Device | 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. |
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| Intravenous cannulation after without prior interventions | Procedure | insertion of 18G catheter in a cubital vein without prior interventions. |
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