Comparison of Ketamine and Esketamine in Patients Suffering From Fibromyalgia Syndrome.

Fibromyalgia Clinical Trial

— KESK-FIQ  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04938713
• Other study ID #: KESK-FIQ
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: August 2021
• Source: Centre Hospitalier Universitaire de Charleroi
• Contact: Brice Constant, MD
• Phone: 0032477504934
• Email: briceconstant[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 30, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• Ketamine 50 MG/ML
Intravenous Ketalar® 0,30 mg/kg in 1 hour.
• Esketamine 25 MG/ML
Intravenous Vesierra® 0,15mg/kg in 1 hour.

Locations

Country	Name	City	State
Belgium	CHU de Charleroi	Lodelinsart	Hainaut

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Charleroi	Centre Hospitalier Universitaire de Liège

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score variations of Fibromyalgia Impact Questionnaire	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.	At day 0 before starting each intravenous perfusion.
Primary	Score variations of Fibromyalgia Impact Questionnaire	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.	At day 7 after each intravenous perfusion.
Primary	Score variations of Fibromyalgia Impact Questionnaire	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.	At day 14 after each intravenous perfusion.
Primary	Score variations of Fibromyalgia Impact Questionnaire	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.	At day 21 after each intravenous perfusion.
Primary	Score variations of Fibromyalgia Impact Questionnaire	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.	At day 28 after each intravenous perfusion.
Secondary	Heart rate disturbances after intravenous perfusion of Ketamine or Esketamine	Measurement of heart rate in Pain clinic during intravenous perfusion. Measurement in beat per minute.	At the beginning (minute zero) of each intravenous perfusion.
Secondary	Heart rate disturbances after intravenous perfusion of Ketamine or Esketamine	Measurement of heart rate in Pain clinic during intravenous perfusion. Measurement in beat per minute.	After 30 minutes of each intravenous perfusion.
Secondary	Heart rate disturbances after intravenous perfusion of Ketamine or Esketamine	Measurement of heart rate in Pain clinic during intravenous perfusion. Measurement in beat per minute.	After 60 minutes of each intravenous perfusion.
Secondary	Heart rate disturbances after intravenous perfusion of Ketamine or Esketamine	Measurement of heart rate in Pain clinic during intravenous perfusion. Measurement in beat per minute.	After 90 minutes of each intravenous perfusion.
Secondary	Heart rate disturbances after intravenous perfusion of Ketamine or Esketamine	Measurement of heart rate in Pain clinic during intravenous perfusion. Measurement in beat per minute.	After 120 minutes of each intravenous perfusion.
Secondary	Variations of Visual Analogue Scale for pain.	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.	At the beginning (minute zero) of each intravenous perfusion.
Secondary	Variations of Visual Analogue Scale for pain.	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.	After 30 minutes of each intravenous perfusion.
Secondary	Variations of Visual Analogue Scale for pain.	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.	After 60 minutes of each intravenous perfusion.
Secondary	Variations of Visual Analogue Scale for pain.	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.	After 90 minutes of each intravenous perfusion.
Secondary	Variations of Visual Analogue Scale for pain.	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.	After 120 minutes of each intravenous perfusion.
Secondary	Variations of Visual Analogue Scale for nausea.	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.	At the beginning (minute zero) of each intravenous perfusion.
Secondary	Variations of Visual Analogue Scale for nausea.	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.	After 30 minutes of each intravenous perfusion.
Secondary	Variations of Visual Analogue Scale for nausea.	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.	After 60 minutes of each intravenous perfusion.
Secondary	Variations of Visual Analogue Scale for nausea.	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.	After 90 minutes of each intravenous perfusion.
Secondary	Variations of Visual Analogue Scale for nausea.	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.	After 120 minutes of each intravenous perfusion.
Secondary	Variations of non-invasive blood pressure.	Measurement of variations of systolic and diastolic non-invasive blood pressure with upper arm cuff. Measurement in mmHg.	At the beginning (minute zero) of each intravenous perfusion.
Secondary	Variations of non-invasive blood pressure.	Measurement of variations of systolic and diastolic non-invasive blood pressure with upper arm cuff. Measurement in mmHg.	After 30 minutes of each intravenous perfusion.
Secondary	Variations of non-invasive blood pressure.	Measurement of variations of systolic and diastolic non-invasive blood pressure with upper arm cuff. Measurement in mmHg.	After 60 minutes of each intravenous perfusion.
Secondary	Variations of non-invasive blood pressure.	Measurement of variations of systolic and diastolic non-invasive blood pressure with upper arm cuff. Measurement in mmHg.	After 90 minutes of each intravenous perfusion.
Secondary	Variations of non-invasive blood pressure.	Measurement of variations of systolic and diastolic non-invasive blood pressure with upper arm cuff. Measurement in mmHg.	After 120 minutes of each intravenous perfusion.
Secondary	Variations of pulse Oxygen saturation.	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.	At the beginning (minute zero) of each intravenous perfusion.
Secondary	Variations of pulse Oxygen saturation.	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.	After 30 minutes of each intravenous perfusion.
Secondary	Variations of pulse Oxygen saturation.	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.	After 60 minutes of each intravenous perfusion.
Secondary	Variations of pulse Oxygen saturation.	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.	After 90 minutes of each intravenous perfusion.
Secondary	Variations of pulse Oxygen saturation.	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.	After 120 minutes of each intravenous perfusion.