Fibromyalgia
Conditions
Keywords
Fibromyalgia, Ketamine, Esketamine, Fibromyalgia Impact Questionnaire, Side effects, Chronic pain
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.
Interventions
Intravenous Ketalar® 0,30 mg/kg in 1 hour.
DRUGEsketamine 25 MG/ML
Intravenous Vesierra® 0,15mg/kg in 1 hour.
Sponsors
Centre Hospitalier Universitaire de Liege
Centre Hospitalier Universitaire de Charleroi
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score variations of Fibromyalgia Impact Questionnaire | At day 0 before starting each intravenous perfusion. | Fibromyalgia Impact Questionnaire (FIQ) completed by the patient. The FIQ was developed from information gathered from patient reports, functional status instruments, and clinical observations. This instrument measures physical functioning, work status (missed days of work and job difficulty), depression, anxiety, morning tiredness, pain, stiffness, fatigue, and well-being over the past week. The score is between 0 and 100. In the severity analysis a FIQ total score from 0 to \< 39 was found to represent a mild effect, ≥ 39 to \< 59 a moderate effect, and ≥ 59 to 100 a severe effect. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate disturbances after intravenous perfusion of Ketamine or Esketamine | At the beginning (minute zero) of each intravenous perfusion. | Measurement of heart rate in Pain clinic during intravenous perfusion. Measurement in beat per minute. |
| Variations of Visual Analogue Scale for pain. | At the beginning (minute zero) of each intravenous perfusion. | Measurement of Visual Analogue Scale (VAS) for pain. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. |
| Variations of Visual Analogue Scale for nausea. | At the beginning (minute zero) of each intravenous perfusion. | Measurement of Visual Analogue Scale (VAS) for nausea. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the no nausea anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater nausea. |
| Variations of non-invasive blood pressure. | At the beginning (minute zero) of each intravenous perfusion. | Measurement of variations of systolic and diastolic non-invasive blood pressure with upper arm cuff. Measurement in mmHg. |
| Variations of pulse Oxygen saturation. | At the beginning (minute zero) of each intravenous perfusion. | Measurement of variations of pulse Oxygen saturation (SpO2). Pulse oximetry is a non-invasive measures of oxygen saturation level in %. A normal SpO2 is typically between 95 and 100 percent. A SpO2 \< 95 percent is considered low. |
Countries
Belgium
Contacts
Primary ContactBrice Constant, MD
Backup ContactRomain Dehavay, MD
Outcome results
None listed