This single-centre, prospective, randomized, double-blind, crossover trial (n=50) aims to compare the efficacy of ketamine and esketamine in ambulatory patients treated for fibromyalgia syndrome in a pain clinic.
Randomised, triple-blind crossover comparing intravenous ketamine (0.3 mg/kg) and intravenous esketamine (0.15 mg/kg) in patients with fibromyalgia; each patient receives two 1-hour infusions of each drug separated by 6 weeks with a 1-week washout.
Primary outcome is change on the Fibromyalgia Impact Questionnaire (FIQ); safety and adverse effects monitored acutely during and after infusions and at follow-up.
Randomised crossover comparing IV ketamine 0.3 mg/kg and IV esketamine 0.15 mg/kg; each drug given as two 1-hour infusions separated by 6 weeks; 1-week washout between periods.
Each infusion given over 1 hour; two infusions per treatment period.
Each infusion given over 1 hour; two infusions per treatment period.