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临床试验/NCT04436250
NCT04436250终止不适用

Intravenous Infusions of S-KETAMINE in Fibromyalgia Syndromes: an Exploratory Study.

Grand Hôpital de Charleroi1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2020年10月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
发起方
入组人数
23
试验地点
1
主要终点
The primary outcome is twofold, aiming on one side pain relief and on the other the improvement of the patient's functional status

研究概览

简要总结

Fibromyalgia is a cause of chronic pain, classified by the Internal Classification of Diseases (ICD) as a primary chronic pain with specific diagnostic criteria established by the American College of Rheumatology (ACR). No treatment to its complete cure is available at this time, all treatments having as purpose pain relief and an improvement of quality of life by combining pharmacologic and nonpharmacologic treatments. One of the mechanisms proposed in fibromyalgia is the central sensitisation phenomenon, by which the central nervous system becomes "hypersensitive" to nociceptive or non-nociceptive stimuli. The receptor involved in this phenomenon is the N-methyl-D-aspartate receptor to which ketamine binds. Ketamine has therefore been proposed as a co-treatment in chronic pain with central sensitization phenomena, such as fibromyalgia.

详细描述

Ketamine is a drug used for anesthesia since the 1970s, acting as an antagonist to the N-methyl-D-aspartate receptor located in the central nervous system. It has two stereoisomers : R +ketamine and S - ketamine, the latter being about two to four times more potent. S-ketamine also has the advantages of producing less psychotropic effects, less tiredness and a lower temporary cognitive impairment than the racemic mixture at equianalgesic doses. Being first used as an anesthetic, in the last twenty years, ketamine's indications expanded to other domains, such as treatment of depression or off label use for chronic pain relief. Chronic pain is a multidimensional syndrome that touches 17-44% of the population of western countries. Fibromyalgia is a cause of chronic pain, classified by the Internal Classification of Diseases (ICD) as a primary chronic pain with specific diagnostic criteria established by the American College of Rheumatology (ACR). No treatment to its complete cure is available at this time, all treatments having as purpose pain relief and an improvement of quality of life by combining pharmacologic and nonpharmacologic treatments (as given by the European League Against Rheumatism (EULAR) guidelines). One of the mechanisms proposed in fibromyalgia is the central sensitisation phenomenon, by which the central nervous system becomes "hypersensitive" to nociceptive or non-nociceptive stimuli. The receptor involved in this phenomenon is the N-methyl-D-aspartate receptor to which ketamine binds. Ketamine has therefore been proposed as a co-treatment in chronic pain with central sensitization phenomena, such as fibromyalgia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

The research pharmacist prepares the syringe with a placebo or active drug (group 1 with 0.2mg/kg or group 2 with 0.4 mg/kg of S-Ketamine) and anonymizes it before giving it to care provider.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients suffering from chronic pain (as defined by International Association for the Study of Pain) being diagnosed as fibromyalgia according to the American College of Rheumatology 2016 criteria
  • patients qualified for the treatment by S-ketamine as established by our latest clinical practice
  • patients aged 18-65 years old

排除标准

  • 未提供

研究组 & 干预措施

Placebo

Active Comparator

Clonidine at a dose of 1 microg/kg Magnesium sulfate at a dose of 40 mg/kg

干预措施: Active comparator (Drug)

S-Ketamine Low dose

Experimental

S-Ketamine at a dose of 0.2 mg/kg

干预措施: Active comparator (Drug)

S-Ketamine Low dose

Experimental

S-Ketamine at a dose of 0.2 mg/kg

干预措施: S-Ketamine Low dose (Drug)

S-ketamine High dose

Experimental

S-ketamine at a dose of 0.4 mg/kg

干预措施: Active comparator (Drug)

S-ketamine High dose

Experimental

S-ketamine at a dose of 0.4 mg/kg

干预措施: S-Ketamine High dose (Drug)

结局指标

主要结局

The primary outcome is twofold, aiming on one side pain relief and on the other the improvement of the patient's functional status

时间窗: 12 weeks

Pain relief will be considered as a two point decrease on the Brief Pain Inventory (BPI) pain severity index at twelve weeks follow-up. (Two points being established as the Minimal Clinically Important Difference (MCID) for fibromyalgic patients). The functional status will be evaluated by the BPI Interference scale. An improvement will be considered as a one point reduction on this index (as established by the MCID). The primary outcome is to determine whether the association of S-ketamine to the analgesic treatment will increase the number of patients showing a clinically significant improvement of pain and/or functional status.

次要结局

  • Number of patients showing 50 % reduction in the BPI (Brief Pain Inventory) pain index(12 weeks)

研究者

发起方
Grand Hôpital de Charleroi
申办方类型
Other
责任方
Sponsor

研究点 (1)

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