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โ† Trials
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The Efficacy and Safety of Short Term S-ketamine Infusion as an Adjunctive Therapy in Patients With Fibromyalgia

RecruitingNAAges 18 Years - anyAllBeijing Tiantan Hospital
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In plain words

What the trial is, and whether it could suit you

Fibromyalgia is a chronic pain syndrome where current medications have limited efficacy and a slow onset of action. Esketamine shows potential as a rapid-acting analgesic, but previous low-dose studies failed to demonstrate long-term benefits. The efficacy of higher-dose ESK as an adjunctive therapy when standard treatments are insufficient remains unclear.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Patients between ages over 18 years with proper cognitive function and language skills for the study; * Patients diagnosed with FM as defined by the ACR FM diagnostic criteria; * Patients who have experienced insufficient symptom relief with non-pharmacological treatments and have not previously received recommended pharmacological treatment for FM; * A score of โ‰ฅ 4 on the average pain intensity over 7 days on the numeric rating scale (NRS) at baseline. Exclusion criteria: * Patient refusal; * Inability to sign informed consent; * Had other secondary FM, this is, hypothyroidism, nutritional deficiency, diabetes mellitus, connective tissue disorder; * Had psychiatric disorder, this is, schizophrenia and other psychotic disorder, bipolar disorder, or personality disorder; * Obstructive sleep apnea syndrome or a STOP-Bang score โ‰ฅ 3; * History of treatment with pregabalin and/or venlafaxine for any disease; * History of treatment with intravenous ketamine or ESK for chronic pain; * Presence of other painful ailments such as inflammatory rheumatic disease; * Uncontrolled diabetes, refractory hypertension, malignancies, narrow-angle glaucoma, hyperthyroidism, severe cardiovascular disease or any other contraindications to esketamine; * History of prescription drug abuse, alcoholism or illicit drug use; * Pregnant or lactating women; * Allergic to any of the study drugs.
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What it tests

  • Pregabalin and venlafaxine concomitant therapy
  • Esketamine plus pregabalin and venlafaxine concomitant therapy
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Where

1 site
Beijing Tiantan Hospital, Beijing, Beijing 100070
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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