NL-OMON54449招募中不适用
The influence of pharmacological conditioning with S-ketamine on pain sensitivity in patients with Fibromyalgia Syndrome - Ketamine conditioning in Fibromyalgia syndrome
niversiteit Leiden0 个研究点目标入组 36 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •- Diagnosed with FMS by a rheumatologist
- •- Age between 18 and 75 years old
- •- Dutch speaking participants
排除标准
- •- A medical diagnosis other than fibromyalgia explaining the chronic pain
- •- Presence of severe and/or uncontrolled co-morbidities: cardiovascular
- •diseases (e.g., heart failure NYHA III or IV, or uncontrolled essential
- •hypertension), neuromuscular diseases, pulmonary obstructive or restrictive
- •diseases, kidney failure (eGFR <= 60), liver diseases or epilepsy)
- •- Presence of any severe psychiatric disease not related to symptoms of FMS
- •(e.g., schizophrenia, schizoaffective disorders, severe anxiety or depression
- •(HADS > 15), bipolar disorder, dissociative personality disorder, or (previous)
- •addiction to strong analgesics.
- •- Presence of any allergy for S(+)-ketamine, midazolam, ondansetron or
- •- Long term use of medicine that is contra-indicated when administering
- •S(+)-ketamine or midazolam: NMDA-receptor antagonists, xanthine derivates,
- •ergometrine, CYP3A4 liver enzyme inhibitors (e.g., verapamil, diltiazem, or
- •certain antibiotics), CYP3A4 liver enzyme inductors (e.g., rifampicin,
- •carbamazepine, fenytoin), and strong opioids (e.g., morphine, fentanyl,
- •- Previous experience(s) with S(+)-ketamine in a medical setting or previous
- •experience with recreational racemic Ketamine use.
- •- Use of painkillers different than usual dose of treatment on the day of
- •experimentation.
- •- Use of alcohol or drugs 24 hours prior to the hospital visits
- •- Use of caffeine 12 hours prior to the hospital visits
- •- Body weight > 100kg or BMI >35
- •- Presence of pregnancy or lactation
- •- Presence of an ICD, pacemaker or implanted medication pump
- •- Presence of chronic pain at the local site of experimental pain stimuli or
- •monitoring devices.
- •- Implanted materials in either arm (e.g., non-removable piercings)
研究者
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