This two-part observational trial (n=50) will evaluate the safety and efficacy of intravenous ketamine infusions (1.5–2 mg/kg over 3–4 hours) in reducing pain among patients diagnosed with fibromyalgia.
Conducted by the Wilderman Medical Clinic in Ontario, Canada, this study includes both retrospective and prospective arms. The retrospective component reviews medical records from fibromyalgia patients who previously received at least four ketamine infusions, assessing their short- and long-term pain relief. The prospective component involves patients who have undergone at least three prior infusions to optimise dosing; these participants will receive one additional infusion and be assessed before, shortly after, and at follow-up for pain reduction, safety, and tolerability.
The study seeks to expand on limited existing research by following the infusion duration and dosing recommendations of established clinical guidelines. It will also explore whether patient characteristics (such as mood or dissociative symptoms) influence treatment response. The aim is to generate data that can inform personalised approaches to ketamine treatment for chronic pain in fibromyalgia.
Trial Details
Previous studies of intravenous ketamine, which is a non-competitive N-methyl-D aspartate receptor antagonist, for fibromyalgia pain relief are limited to three studies. Two studies have focused on short-term pain relief of intravenous ketamine by measuring the patients' pain levels immediately before and after the infusion. Currently, existing studies used short-term infusions (30-40 minutes) of sub-anesthetic doses of ketamine for pain relief in fibromyalgia patients, whereas the Consensus Guidelines on the Use of Intravenous Ketamine Infusions for Chronic Pain from the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine, and the American Society of Anesthesiologists recommend infusing IV ketamine for at least two hours and a minimal total dose of 80 mg. The rationale of this study is to expand on the existing data of safety and efficacy of intravenous ketamine to relieve fibromyalgia pain. Specifically, this investigation will add data to fill the existing gap regarding the short- and long-term pain relief in the treatment of fibromyalgia with intravenous ketamine infusions. The study will also attempt to determine safety and tolerability. In addition, the characteristics of treatment responders versus non-responders will be assessed in an effort to determine whether specific characteristics can be used to predict treatment response in this group of patients.Trial Number NCT06916403