The Use of MicronJet600 Microneedle for Intradermal Lidocaine Injection to Ensure Local Anaesthesia During Insertion of Peripheral Venous Catheters
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Pain scores, reported by the subjects due to painful stimulus by intravenous catheterisation with 18G cannula
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any gender
- •Age at 18-65 years
排除标准
- •Pregnant or lactating women
- •Evidence of allergy to lidocaine
- •Presence of pain of any localization and character not associated with the study or treatment with any analgesics
- •Any perceptual disorders
- •Neuropathies or stroke in anamnesis
- •Any psychiatric disorders
- •Any disorder of tissues at the site of intervention - the antecubital fossa
结局指标
主要结局
Pain scores, reported by the subjects due to painful stimulus by intravenous catheterisation with 18G cannula
时间窗: Immediately after 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.
Prevalence of adverse events.
时间窗: 24 hours after the lidocaine injection with MicronJet600.
Any kind of local and systemic adverse events were recorded after the lidocaine injection with MicronJet600 followed by the intravenous cannulation.
Pain scores, reported by the subjects due to painful stimulus due to a pin-prick with a 27G needle (1)
时间窗: At 15 minutes after the intradermal lidocaine injection.
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.
Pain scores, reported by the subjects due to painful stimulus due to a pin-prick with a 27G needle (2)
时间窗: At 30 minutes minutes after the intradermal lidocaine injection.
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.
Pain scores, reported by the subjects due to painful stimulus due to a pin-prick with a 27G needle (3)
时间窗: At 45 minutes after the intradermal lidocaine injection.
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.
次要结局
- Preference to receive injection of lidocaine with MicronJet600 prior to intravenous cannulation, over the cannulation without any pre-treatment.(Immediately after the intravenous catheterisation with 18G cannula.)