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临床试验/NCT03344510
NCT03344510已完成不适用

Kinetic Anesthesia Device for Lidocaine Injection: a Randomized Split-body Study of the Effects of Kinetic Anesthesia Devices on Pain of Lidocaine Injection in Healthy Volunteers

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2017年1月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
47
试验地点
2
主要终点
Pain of Lidocaine Injection, Measured by Visual Analog Scale.

研究概览

简要总结

Patients experience discomfort from lidocaine injections. Vibrating kinetic anesthesia devices (KAD) have been shown to reduce pain of injections in dentistry, pediatrics, and dermatology, though no studies of lidocaine injections in sites common to dermatologic surgery exist. We will conduct a randomized split-body study, in which healthy volunteers will rate the pain of lidocaine injections on a visual analog scale, with and without the vibrating kinetic anesthesia device being used during injection

详细描述

The study will be an open label split-body crossover trial, using healthy adult volunteers recruited from the faculty, staff and student body of the University of Pennsylvania, and from the University City area of Philadelphia. Participants will be randomized to one of three anatomic sites deemed relevant: the nasofacial sulcus, the lateral forehead, and the upper back. Participants will then be randomized to receive injection with the KAD first or second. The injection will be 0.5 cc of room temperature buffered lidocaine injected at constant slow speed (approximately 5 seconds) through a 30-gage needle held perpendicular to the skin by the same surgeon, with verbal cues standardized. Injections will be given in accordance with the standard of practice. When the KAD is used it will be used as directed: firmly pressed on the skin adjacent to the injection, with the needle aimed into the lighted area. Volunteers will evaluate each injection immediately after it is complete using the visual analog scale. When both injections are completed, participants will indicate their preference of injection, complete qualitative questions, and note necessary demographic information. Injection location and order of intervention (i.e. first or second) will be noted.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult volunteers greater than or equal to 18 years of age
  • Able and willing to provide informed consent
  • Able to comprehend and comply with study instructions, and able to complete necessary evaluations.

排除标准

  • Patients unable or unwilling to provide informed consent.
  • Patients with lidocaine allergy
  • Patients with known pain-related or neurological condition.
  • Patients with a known cardiac condition
  • Vulnerable populations

研究组 & 干预措施

Kinetic anesthesia device, then no intervention

Experimental

In this arm of the crossover study, participants will receive lidocaine injection in conjunction with the kinetic anesthesia device, then will receive an injection without the kinetic anesthesia device intervention

干预措施: Kinetic Anesthesia Device (Device)

Kinetic anesthesia device, then no intervention

Experimental

In this arm of the crossover study, participants will receive lidocaine injection in conjunction with the kinetic anesthesia device, then will receive an injection without the kinetic anesthesia device intervention

干预措施: Control (Other)

No intervention, then kinetic anesthesia device

Experimental

In this arm of the crossover study, participants will receive lidocaine injection without the kinetic anesthesia device intervention, then will receive an injection in conjunction with the kinetic anesthesia device.

干预措施: Kinetic Anesthesia Device (Device)

No intervention, then kinetic anesthesia device

Experimental

In this arm of the crossover study, participants will receive lidocaine injection without the kinetic anesthesia device intervention, then will receive an injection in conjunction with the kinetic anesthesia device.

干预措施: Control (Other)

结局指标

主要结局

Pain of Lidocaine Injection, Measured by Visual Analog Scale.

时间窗: This measurement will occur immediately after each injection

Participants will be asked to mark the pain of injection on a 100mm visual analog scale. The visual analog scale is commonly used to measure acute pain, though it can be used in other settings. It consists of a line 100mm long. The left end is labeled "no pain at all" and the right end is labeled "worst pain imaginable." Participants will rate pain by marking the scale where they feel that their level of pain falls on the scale. The length from 0 to the participant's mark will be measured in millimeters (for a range of 0 to 100 mm possible). Higher numbers will be considered more pain.

次要结局

  • Patient Preference for Injection With or Without Kinetic Anesthesia Device(This will occur immediately after the second injection)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joseph F Sobanko M.D.

Assistant Professor, Dermatology

University of Pennsylvania

研究点 (2)

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