The Role of Qutenza (Topical Capsaicin 8%) in Treating Neuropathic Pain From Arteriovenous Fistulae in Patients With End Stage Renal Failure
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Neuropathic pain
研究概览
简要总结
Arteriovenous fistulae are artificial connections between the artery and vein in the arm which allow needles to be inserted for haemodialysising patients wit kidney failure. Occasionally severe debilitating pain can arise from these fistulae for which no cause can be found. Such pain can be very difficult to treat. Many commonly used used painkillers are known to cause significant side effects in patients with renal failure (drowsiness, confusion etc.
Qutenza (topical capsaicin 8%) is a new treatment made from chilli peppers which is applied to the skin as a patch and works directly at the nerve endings in the skin to prevent pain. It therefore should not have the systemic side effects of other drugs. It has been demonstrated to be beneficial in other painful conditions for example post-shingles pain and nerve pain from HIV. It has never been used for critical ischaemia before.
We propose to investigate the efficacy of Qutenza in treating patients with end stage renal failure and chronic pain from their fistulae (AVF). We will recruit 20 patients with painful AVF and treat them with Qutenza. We will follow them up for 12 weeks and monitor the change in their pain scores.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult patients >18 years old with end stage renal disease on dialysis and significant chronic neuropathic pain arising from their arteriovenous fistula (defined as pain with symptoms to suggest a neuropathic element occurring most days for at least a month which has not responded to simple analgesia)
排除标准
- •Pre-dialysis
- •Underlying anatomical/ structural abnormality with AVF contributing to pain
- •Diabetic neuropathy resulting in sensory loss
- •Hypersensitivity to Qutenza, Emla or any of the excipients
- •Broken skin or active ulceration at the site of application
- •Severe uncontrolled hypertension (systolic BP >200)
- •Proven cardiac event during the preceding 3 months
- •Women who are pregnant or breast feeding
- •Lack of capacity or inability to provide informed consent
- •Declines participation in the study
研究组 & 干预措施
Experimental: Qutenza
Single treatment with Qutenza (topical capsaicin8%) transdermal patch
干预措施: Qutenza (Drug)
结局指标
主要结局
Neuropathic pain
时间窗: 12weeks
As assessed by Visual Analogue Pain Score
次要结局
- Neuropathic pain(1 week, 6 weeks)
- Safety and tolerability(1 week, 6 weeks and 12 weeks)
- Quality of life(6 weeks, 12 weeks)
研究者
Dr Patrick Kearns
Principal Investigator
NHS Greater Glasgow and Clyde