Prospective, Randomized, Blinded,Comparative Efficacy and Safety Trial of Vapocoolant (Pain Ease Medium Stream) for Venipuncture
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Pain Scale on Numeric Rating Scale (NRS) ( 0 to 10)
研究概览
简要总结
To determine the efficacy and safety of vapocoolant spray (Pain Ease Medium Stream) in decreasing the pain of venipuncture ("blood draw")
详细描述
This is a prospective, randomized, blinded, comparator study. This study design is considered standard for establishing safety and efficacy data. Active treatment vapocoolant spray (Pain Ease Medium Stream) spray) will be used. There will be a placebo (sterile water) in this study. The population selected for this study, adults (excluding the very old, > 80 years old) represents a patient population that may benefit from vapocoolant spray. This is a patient population that according to the treating health care provider already requires venipuncture for "blood draw" but not intravenous cannulation. Because venipuncture is a painful procedure, 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient needing venipuncture ("blood draw') but not intravenous cannulation
- •Adult 18 years and older up to and and including 80 years old
- •Stable patient
- •Mentally competent patient able to understand the consent form
排除标准
- •Patients with any allergies to the spray components (e.g. 1,1,1,3,3 pentafluoropropane or 1,1,1,2, tetrafluoroethane )
- •Critically ill or unstable (e.g. sepsis or shock)
- •Extremes of age: geriatric (> 80 years) or pediatric ( < 18 years old)
- •Venipuncture site located in area of compromised blood supply. Examples include : patients with peripheral vascular disease, gangrene, Raynaud's disease, Buerger's disease.
- •Venipuncture site located in area of insensitive skin; patients with a peripheral neuropathy including diabetic neuropathy.
- •Patient intolerant of cold or with hypersensitivity to the cold.
- •Patient unable or unwilling to give consent.
- •Prior experience with vapocoolant spray
- •Currently in another research trial
结局指标
主要结局
Pain Scale on Numeric Rating Scale (NRS) ( 0 to 10)
时间窗: Less than 10 minutes after stream application.
NRS scale: 0-10 ; No pain (0) - (5) moderate pain - Worst pain (10)
次要结局
未报告次要终点
研究者
Sharon Mace
Principal Investigator
The Cleveland Clinic