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.
Rationale: existing evidence for IV ketamine in fibromyalgia is limited and largely short-term; this study aims to expand data on short- and long-term pain relief and safety/tolerability.
Design: two-part single-centre study (Wilderman Medical Clinic). Part 1: retrospective chart review of patients with ≥4 infusions. Part 2: open single-group prospective study enrolling patients with ≥3 prior infusions to receive one IV ketamine infusion and standardised assessments.
Outcomes: primary focus on change in pain (NRS) at acute and follow-up timepoints; secondary analyses include safety/tolerability, dissociative symptoms, depressive status and characteristics of responders vs non-responders.
Approximately 30 patients will receive a single IV ketamine infusion as part of a prospective single-group study; assessments at baseline, 40 minutes post-infusion and follow-up visits.
Infused over 3–4 hours; routine target dose 1.5–2 mg/kg.
Chart review of ~20 patients who previously received IV ketamine infusions for fibromyalgia (≥4 infusions) to summarise clinically relevant outcomes.
Retrospective group received ≥4 prior infusions; routine dosing reported as 1.5–2 mg/kg over 3–4 hours.