Clinical trial NCT04938713: Comparison of Ketamine and Esketamine in Patients Suffering From Fibromyalgia Syndrome.
Official title: Comparison of Ketamine and Esketamine in Ambulatory Patients Treated for Fibromyalgia Syndrome in Pain Clinic. A Single-center, Prospective, Randomized, Double-blind, Crossover Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Ketamine
Esketamine
Fibromyalgia Impact Questionnaire
Side effects
Chronic pain
Lead sponsor: Centre Hospitalier Universitaire de Charleroi
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire de Liege
First posted: 2021-06-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Ketamine and Esketamine intravenous perfusions in Pain Clinic can modulate chronic pain and are therefore part of the therapeutic arsenal of the Anesthesiologist in pain management. Patients with fibromyalgia syndrome have elevated levels of glutamate in the brain. This is demonstrated by functional brain imaging techniques. Elevation of glutamate is demonstrated in the posterior insular cortex, positively correlating with lower pain thresholds which is a hallmark of fibromyalgia syndrome. Ketamine has (e.a.) an inhibitory role of the N-methyl-D-aspartate (NMDA) receptor: it is a non-competitive antagonist of the NMDA receptor. In this context, Esketamine is available recently. This is the levorotatory form of Ketamine.

The main objective of this study is to measure if there is a difference between Ketamine and Esketamine on patients with fibromyalgia syndrome via the fibromyalgia impact questionnaire (FIQ) and measurement of side effects after intravenous perfusion. The fibromyalgia impact questionnaire is a global assessment of symptoms: pain, function, fatigue, stiffness, discomfort when walking up stairs, difficulties at work, anxiety, depression, days not worked and days of good quality in the past week.

Eligibility criteria: Inclusion Criteria:

* Male and female
* Between 18 and 75 years old
* Reads and writes French
* Diagnosis of fibromyalgia syndrome according to Widespread Pain Index (WPI) and Symptom Severity Scale (SSS) score ≥ 13/31
* Both molecules (Ketamine and Esketamine) were administered at least once during an analgesic infusion session in Pain Clinic
* Patient with regular medical follow-up by a pain specialist at least 3 times a year

Exclusion Criteria:

* Allergy or intolerance to Ketamine or Esketamine
* Current infection, fever
* Pregnant or breastfeeding woman
* Serious cardiovascular disorders and severe hypertension
* Increased pressure of cerebrospinal fluid and severe intracranial disease
* Acute intermittent porphyria
* Untreated epilepsy
* Untreated glaucoma
* Difficult or impossible intravenous access
* Chronic Liver Disease Child-Pugh C

Primary outcomes:
measure: Score variations of Fibromyalgia Impact Questionnaire
timeFrame: At day 0 before starting each intravenous perfusion.
measure: Score variations of Fibromyalgia Impact Questionnaire
timeFrame: At day 7 after each intravenous perfusion.
measure: Score variations of Fibromyalgia Impact Questionnaire
timeFrame: At day 14 after each intravenous perfusion.
measure: Score variations of Fibromyalgia Impact Questionnaire
timeFrame: At day 21 after each intravenous perfusion.
measure: Score variations of Fibromyalgia Impact Questionnaire
timeFrame: At day 28 after each intravenous perfusion.
Secondary outcomes:
measure: Heart rate disturbances after intravenous perfusion of Ketamine or Esketamine
timeFrame: At the beginning (minute zero) of each intravenous perfusion.
measure: Heart rate disturbances after intravenous perfusion of Ketamine or Esketamine
timeFrame: After 30 minutes of each intravenous perfusion.
measure: Heart rate disturbances after intravenous perfusion of Ketamine or Esketamine
timeFrame: After 60 minutes of each intravenous perfusion.
measure: Heart rate disturbances after intravenous perfusion of Ketamine or Esketamine
timeFrame: After 90 minutes of each intravenous perfusion.
measure: Heart rate disturbances after intravenous perfusion of Ketamine or Esketamine
timeFrame: After 120 minutes of each intravenous perfusion.
measure: Variations of Visual Analogue Scale for pain.
timeFrame: At the beginning (minute zero) of each intravenous perfusion.
measure: Variations of Visual Analogue Scale for pain.
timeFrame: After 30 minutes of each intravenous perfusion.
measure: Variations of Visual Analogue Scale for pain.
timeFrame: After 60 minutes of each intravenous perfusion.
measure: Variations of Visual Analogue Scale for pain.
timeFrame: After 90 minutes of each intravenous perfusion.
measure: Variations of Visual Analogue Scale for pain.
timeFrame: After 120 minutes of each intravenous perfusion.
measure: Variations of Visual Analogue Scale for nausea.
timeFrame: At the beginning (minute zero) of each intravenous perfusion.
measure: Variations of Visual Analogue Scale for nausea.
timeFrame: After 30 minutes of each intravenous perfusion.
measure: Variations of Visual Analogue Scale for nausea.
timeFrame: After 60 minutes of each intravenous perfusion.
measure: Variations of Visual Analogue Scale for nausea.
timeFrame: After 90 minutes of each intravenous perfusion.
measure: Variations of Visual Analogue Scale for nausea.
timeFrame: After 120 minutes of each intravenous perfusion.
measure: Variations of non-invasive blood pressure.
timeFrame: At the beginning (minute zero) of each intravenous perfusion.
measure: Variations of non-invasive blood pressure.
timeFrame: After 30 minutes of each intravenous perfusion.
measure: Variations of non-invasive blood pressure.
timeFrame: After 60 minutes of each intravenous perfusion.
measure: Variations of non-invasive blood pressure.
timeFrame: After 90 minutes of each intravenous perfusion.
measure: Variations of non-invasive blood pressure.
timeFrame: After 120 minutes of each intravenous perfusion.
measure: Variations of pulse Oxygen saturation.
timeFrame: At the beginning (minute zero) of each intravenous perfusion.
measure: Variations of pulse Oxygen saturation.
timeFrame: After 30 minutes of each intravenous perfusion.
measure: Variations of pulse Oxygen saturation.
timeFrame: After 60 minutes of each intravenous perfusion.
measure: Variations of pulse Oxygen saturation.
timeFrame: After 90 minutes of each intravenous perfusion.
measure: Variations of pulse Oxygen saturation.
timeFrame: After 120 minutes of each intravenous perfusion.
Other outcomes:
Locations:
city: Lodelinsart
country: Belgium
facility: CHU de Charleroi
state: Hainaut
Study officials:
affiliation: Centre Universitaire de Charleroi
name: Brice Constant, MD
role: PRINCIPAL_INVESTIGATOR
References: