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临床试验/NCT05744557
NCT05744557终止不适用

Vapocoolant Analgesia for Breast Lymphoscintigraphy

M.D. Anderson Cancer Center2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
30
试验地点
2
主要终点
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

研究概览

简要总结

To learn if applying vapocoolant anesthetic spray ("Nüm") on the surface of the intended injection site will reduce the pain/anxiety associated with breast injections.

详细描述

Primary Objectives:

  1. Establish feasibility of topical vapocoolant in the setting of breast lymphoscintigraphy.
  2. Demonstrate safety of topical vapocoolant in the setting of breast lymphoscintigraphy.

Secondary Objectives:

  1. To assess patient pain intensity associated with the performance of breast lymphoscintigraphy.
  2. To evaluate the attitude from patients about supporting the continued offering of topical vapocoolant in the breast lymphoscintigraphy clinic.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • Any adult patient undergoing asubareolar breast lymphoscintigraphy injection will be eligible.
  • Age ≥18 years old
  • Ability to understand and the willingness to sign a written informed consent document.
  • Childbearing potential, lactating, pregnant women will be included.

排除标准

  • Patients who have allergy or had prior hypersensitivity to either of the vapocoolants including 1,1,1,3,3 Pentafluoropropane and 1,1,1,2-Tetrafluoroethane.
  • Patients with uncontrolled intercurrent illness (insulin dependent and non-insulin dependent diabetes)
  • Patients with psychiatric illness/social situations that would limit compliance with study requirements.

结局指标

主要结局

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

时间窗: through study completion; an average of 1 year.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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