The Efficacy and Safety of Short Term S-ketamine Infusion as an Adjunctive Therapy in Patients Wi… (NCT07230171) | Clinical Trial Compass
RecruitingNot Applicable
The Efficacy and Safety of Short Term S-ketamine Infusion as an Adjunctive Therapy in Patients With Fibromyalgia
China92 participantsStarted 2025-09-15
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ≥ 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 ≥ 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.