The Efficacy and Safety of Short Term S-ketamine Infusion as an Adjunctive Therapy in Patients With Fibromyalgia
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Trial details
- Who runs it
- Beijing Tiantan Hospital
- Trial code
- NCT07230171
- Record updated
- 30 October 2026
- Original description
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.Read full original descriptionShow less
Comparing the Efficacy and Safety of Conventional Therapy With Conventional Therapy Combined Esketamine in the Treatment of Fibromyalgia: A Multicenter Clinical Study
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.
Inclusion: 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: History of treatment with pregabalin and/or venlafaxine for any disease; History of treatment with intravenous ketamine or ESK for chronic pain; 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; 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; Allergic to any of the study drugs; Patient refusal; Inability to sign informed consent; Pregnant or lactating women.