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临床试验/NCT04762121
NCT04762121撤回不适用

Preliminary Prospective Observational Study on Peripheral Intravenous Catheter Insertion

Steward St. Elizabeth's Medical Center of Boston, Inc.1 个研究点 分布在 1 个国家开始时间: 2012年2月12日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Pain with IV Cannulation based on the Visual Analog Scale

研究概览

简要总结

IV placement is a common and necessary for surgical procedures. Unfortunately, pain associated with needle catheterization experienced during peripheral IV placement is a source anxiety and discomfort in many patients. The intensity of pain and distress caused by procedures can vary from mild to moderate, but also may be severe in certain patients resulting in numerous physiological, psychological, and emotional consequences. As such, the investigators ultimately aim to evaluate the techniques that could make the placement of the IV more comfortable.

详细描述

As a preliminary study, the investigators are interested in conducting a prospective observational study to collect baseline data to characterize and collect baseline data on pain associated with needle catheterization in the hospital.

Many factors including size of needle, experience of the individual placing IV, previous history of depression may vary the IV placement experience of a patient; however, only some of these factors may directly affect the magnitude of pain experienced by a patient. Currently, there is limited literature available on what factors affect the pain/satisfaction patients experience with IV insertion. Soysal et al. have previously reported that depressed patients reported higher severity of pain during IV catheter placement than non-depressed patients in a cross-sectional, observational study (n= 925). The authors have also demonstrated that age, sex, site of IV catheter insertion, use of antidepressant drugs, and whether the individual placing the IV catheter is a nurse or physician do not affect the magnitude of pain. Similarly, Van Loon et al have demonstrated that insertion of a smaller sized peripheral intravenous catheter did not result in lower pain sensation. However, Galvin et al. conducted a randomized clinical trial that demonstrated that the site of IV catheter insertion makes a difference in the pain patients feel during IV catheter insertion. Furthermore, no study exists that has investigated whether patients experience a different magnitude of pain when different levels of physician trainees place the IV catheter. Also, no study exists that compares whether peripheral IV cannulation with no pain relief method versus intradermal lidocaine 1% injection versus intradermal lidocaine 2% injection versus Buzzy® device affect the pain/satisfaction that patients experience with IV catheter insertion.

Through the conduction of this study, the investigators hope to further evaluate which factors and techniques affect the experience patients have with peripheral IV cannulation; this knowledge could help the investigators figure out ways to make IV cannulation as comfortable as possible for patients in the future.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Adults ages 18 to 99
  • •Patients requiring intravenous catheter insertion for their operation/procedure.

排除标准

  • 未提供

结局指标

主要结局

Pain with IV Cannulation based on the Visual Analog Scale

时间窗: 5-20 minutes

How much pain do adult patients experience with peripheral IV cannulation with no pain relief method versus intradermal lidocaine 1% injection versus intradermal lidocaine 2% injection versus Buzzy® device? The Visual Analog Scale is used for linear measurement of pain, where the minimum number is 0 (no pain) and the maximum number is 10 (unimaginable pain).

次要结局

  • Pain related to IV size based on the Visual Analog Scale(5-20 minutes)
  • Pain from IV insertion based on the Visual Analog Scale related to history of patient having anxiety(5-20 minutes)
  • Pain from IV insertion based on the Visual Analog Scale related to history of patient having depression(5-20 minutes)
  • Satisfaction with IV cannulation based on the Numerical Rating Scale(5-20 minutes)
  • Pain related to IV location based on the Visual Analog Scale(5-20 minutes)
  • Pain from IV insertion related to stage of the training of the healthcare provider based on the Visual Analog Scale(5-20 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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