Will Patients Perceive a Vapocoolant Spray to be Effective in Reducing Pain and Increasing Satisfaction With Insertion at an Intravenous Site?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pain Scale Using Visual Analog Scale
研究概览
简要总结
The primary purpose of this study is to determine if by offering a vapocoolant (cold spray) to hospital outpatients prior to an intravenous catheter (IV) insertion will increase patient satisfaction of IV insertion as well as determine if pain of insertion is decreased.
详细描述
This is a single blind interventional study with a post design using a convenience sample of patients undergoing a Nuclear Medicine Stress Test. The patient selection and intervention will be randomized in order to ensure a high validity study. The interventional treatment used will be a ethyl chloride mist spray manufactured by the Gebauer Company. The placebo spray that will be used is manufactured by BioLogic Aqua Research Technologies International Inc. The spray is called Nature's Tears Mist and is a sterile water. The patient's for this study are required to have intravenous cannulation (IV) access. This is a painful and invasive procedure in which a vapocoolant may confer benefit for the relief of pain.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any outpatient ordered to undergo a Nuclear Medicine Stress Test and is required to have IV access for injection of Radiopharmaceuticals
排除标准
- •If it is the first time the patient has had an intravenous catheter inserted
- •Any patient who is or may be pregnant
- •Any patient who is breast-feeding
- •Any patient who has taken a narcotic, sedative and/or anti-anxiety medication within 8 hours of intervention time.
- •Any patient who has a known diagnosis of Raynaud's Syndrome or Carpal Tunnel Syndrome.
- •Any patient who has an allergy or hypersensitivity to Ethyl Chloride.
- •Any patient under the age of 18 and/or any patient over the age of 85
- •Any patient who is illiterate
- •Any patient who is non-English speaking
- •Any patient with prior experience with a vapocoolant spray.
研究组 & 干预措施
Gebauer Ethyl Chloride
Device: Vapocoolant (Ethyl Chloride Mist Spray)
干预措施: Gebauer Ethyl Chloride (Drug)
Nature's Tears
Device: Sterile Water
干预措施: Nature's Tears (Drug)
结局指标
主要结局
Pain Scale Using Visual Analog Scale
时间窗: less than 5 minutes following spray application
0-No Pain; 1-3 Mild Pain; 4-6 Moderate-Severe Pain; 7-9 Very Severe Pain;10 Worst Possible Pain
次要结局
- Satisfaction Scale Using 1-5 Likert Scale(less than 5 minutes following spray application)
- Would Patient Choose to Have Intervention Again if IV Catheter Insertion is Needed(less than 10 minutes following spray application)
- Using the Same Visual Analog Scale Rate Pain the Last Time the Patient Remembers Having an IV Inserted(At baseline prior to spray application)
- Using the Same Likert Scale Rate How Satisfied the Patient Remembers the Last Time They Had IV Catheter Inserted(At baseline prior to spray application)