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.
Fibromyalgia patients often have elevated glutamate levels in the brain, contributing to lower pain thresholds. Both ketamine and esketamine modulate chronic pain, with esketamine being the levorotatory form of ketamine. The study’s main objective is to measure the difference between ketamine and esketamine using the Fibromyalgia Impact Questionnaire (FIQ) and assess side effects after intravenous perfusion.
Participants aged 18 to 75, diagnosed with fibromyalgia syndrome, and who have received both ketamine and esketamine during analgesic infusion sessions are eligible. The study adopts a randomized crossover design, with participants divided into two groups: AB and BA. Each patient will receive two infusions of ketamine and two infusions of esketamine in different sequences, with a washout period in between to avoid carry-over effects.
Primary outcome measures include variations in FIQ scores, assessed before and after each intravenous perfusion. Secondary outcome measures include heart rate disturbances, variations in Visual Analogue Scale (VAS) for pain and nausea, and variations in non-invasive blood pressure and pulse oxygen saturation during intravenous perfusion.
The study is conducted at CHU de Charleroi, Belgium, with a study start date of July 1, 2021, and an estimated completion date of September 30, 2022. It is led by Brice Constant, MD, and Romain Dehavay, MD, serves as the study contact backup.
Trial Details
Ketamine and Esketamine intravenous perfusions can modulate chronic pain. The purpose of this study is to determine if Ketamine or Esketamine are favorable for outpatients suffering from fibromyalgia.NCT Number NCT04938713