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临床试验/NCT05555173
NCT05555173撤回不适用

IVs With Buzzy in Chronic Pain Patients

Steward St. Elizabeth's Medical Center of Boston, Inc.1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
入组人数
10
试验地点
1
主要终点
Pain on the Numeric Rating Scale

研究概览

简要总结

The investigators are conducting a study to compare the effectiveness of the Buzzy® device with that of no pain relief method for IV placement in adults with chronic pain receiving lidocaine infusions.

详细描述

IV placement is necessary for lidocaine infusions. Unfortunately, some patients say that placing an IV is painful. The investigators are conducting this study to evaluate two techniques that could make the placement of the IV more comfortable. Currently, some medical providers administer the IV without any pain-relieving techniques. Some medical providers place a device called Buzzy® on a patient's arm prior to the IV placement. The Buzzy® device is the combination of an ice pack and a vibrator in the shape of a bumble bee. Literature shows that the Buzzy® device makes IV placement more comfortable for children, but there is minimal data in regard to whether it is helpful for adult patients. The investigators are conducting this study to compare the effectiveness of the Buzzy® device with that of no pain relief method for IV placement in adults with chronic pain receiving lidocaine infusions. The use of the Buzzy® device in adults is the investigational part of the study. This device has been FDA approved for use.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
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

  • Patients receiving lidocaine infusions at the pain clinic.

排除标准

  • 未提供

研究组 & 干预措施

No Buzzy

No Intervention

Subjects will have a 20g intravenous catheter inserted either in the left or right dorsum side of the hand without the Buzzy device.

Buzzy

Experimental

Buzzy will be applied 5 to 10 cm proximal (toward the subject's head) to the dorsum of the hand site immediately prior and throughout the intravenous catheter insertion attempt.

干预措施: Buzzy (Device)

结局指标

主要结局

Pain on the Numeric Rating Scale

时间窗: through study completion, an average of 2 months

Patients are asked to report their subjective pain on the Numeric Rating Scale from 0 to 10, where 0 = No Pain and 10 = Worst Pain.

次要结局

  • Satisfaction on the Visual Analog Scale(through study completion, an average of 2 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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