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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Qutenza | Single treatment with Qutenza (topical capsaicin8%) transdermal patch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Qutenza | Drug | Transdermal patch |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Neuropathic pain | As assessed by Visual Analogue Pain Score | 12weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Neuropathic pain | As assessed by Visual Analogue Pain Score and Brief Pain Inventory | 1 week, 6 weeks |
| Quality of life | As assessed by EQ-5D |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with end stage renal failure and chronic neuroapthic pain arising fromt heir arteriovenous fistulae
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marc Clancy, PhD FRCS | Contact | 0141 451 6210 | Marc.Clancy@ggc.scot.nhs.uk | |
| Patrick K Kearns, MBChB | Contact | 0141 451 6210 | Patrickkearns@nhs.net |
| Name | Affiliation | Role |
|---|---|---|
| Patrick K Kearns, MBChB | NHS Greater Glasgow and Clyde | Principal Investigator |
| Marc Clancy, FRCS, PhD | NHS Greater Glasgow and Clyde | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Renal Surgery, Queen Elizabeth University Hospital | Recruiting | Glasgow | Lanarkshire | G51 4TF | United Kingdom |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002211 | Capsaicin |
| ID | Term |
|---|---|
| D053284 | Polyunsaturated Alkamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000475 | Alkenes |
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| 6 weeks, 12 weeks |
| Safety and tolerability | As assessed by: Number of adverse reactions. | 1 week, 6 weeks and 12 weeks |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D006839 |
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |