Effect of Topical Anesthesia on Patient's Pain Discomfort and Radial Artery Spasm in Transradial Catheterization
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Radial pain assessed during artery puncture
研究概览
简要总结
This study evaluate topical anaesthesia application for 30 minutes before tranradial catheterization during cardiac catheterization can reduce pain and decrease radial artery spasm
详细描述
The incidence of Radial artery spasm (RAS) has varied from 5-30% RAS refers to friction between the artery and wires or guide catheters accompanied by a subjective feeling of pain.
EMLA anesthetic ointment (AO-Astra Zeneca) is an emulsion of lidocaine 2.5% and prilocaine 2.5% in a ratio of 1:1 by weight Previous study showed that EMLA cream can increase the success rate of femoral cannulation in children.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Patients age >18 years.
- •Patients who was schedule to performed coronary angiogram
排除标准
- •Previous ipsilateral transradial approach Raynaud's syndrome ESRD History of sensitivity to local anesthetics Non-palpable redial pulse Abnormal Barbeau's test Local site infection Patient's refusal
研究组 & 干预措施
Interventional
EMLA group layer of 2.5 gr EMLA cream (standard adult dose) was applied to both wrists
干预措施: Topical Anesthetic (Drug)
Placebo
Placebo cream was applied to both wrists
干预措施: Placebo (Drug)
结局指标
主要结局
Radial pain assessed during artery puncture
时间窗: 30 min
Record pain by visual analog score sub-scale 0(no pain)-10(max pain)
次要结局
- Radial pain assessed 30 min after sheath removal(4 hr post procedure)
- Number of puncture attempts(imediate post procedure)
- Occurrence of radial artery spasm(during and post procedure up to 1 years)