A Randomized Clinical Trial of Cutaneous Xylocaine Spray to Reduce Intravenous Cannulation Pain in Adults
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Isala
- 入组人数
- 17
- 主要终点
- The pain score of the tested subjects during intravenous cannulation
研究概览
简要总结
The enrolled subjects will get an intravenous cannulation in both elbows. The subject will get before xylocaine spray is placed, the intervention-arm, one intravenous cannulation in one of the elbows, the other intravenous cannulation is placed in the other arm before placebo spray is placed, the control arm. The pain score during insertion of the cannulation, the incidence of adverse events and the success rate and degree of difficulty to place an intravenous cannulation. The subjects and the one who place the cannulations will be blinded to the treatment.
详细描述
The enrolled subjects will get an intravenous cannulation in both elbows. The influence of the left or right-handedness is reduced by randomizing the arms of the subjects in the placebo group or xylocaine group. The subject will get before xylocaine spray is placed, the intervention-arm, one intravenous cannulation in one of the elbows, the other intravenous cannulation is placed in the other arm before placebo spray is placed, the control arm. The pain score during insertion of the cannulation, the incidence of adverse events and the success rate and degree of difficulty to place an intravenous cannulation. The subjects and the one who place the cannulations will be blinded to the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults (aged 18 or older)
- •Signing of the informed consent paper
排除标准
- •Allergy for xylocaine
- •Pregnancy or breast-feeding
- •Peripheral neuropathy
- •Analgesics in the last 24 hours
- •Skin conditions (eczema, psoriasis, infection, or abrasions)
- •Difficulties in verbal communication
- •No intravenous access in both elbows possible (eg status after axillary dissection )
研究组 & 干预措施
Xylocaine spray
干预措施: Xylocaine spray (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
The pain score of the tested subjects during intravenous cannulation
时间窗: A few seconds after intravenous cannulation
Visual Analogue Scale (VAS) (0 = no pain, 10 = severe pain)
次要结局
- Complications or adverse reactions of xylocaine spray or placebo spray(5 minutes after xylocaine spray or placebo and 15 minutes after cannulation)
- Influence of xylocaine spray in successfully placing an IV cannulation(Before intravenous cannulation)
- The degree of difficulty in successfully placing an IV cannulation(A few seconds after intravenous cannulation)