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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
Intravenous Ketalar® 0,30 mg/kg in 1 hour.
Intravenous Vesierra® 0,15mg/kg in 1 hour.
CHU de Charleroi
Lodelinsart, Hainaut, Belgium
RECRUITINGScore 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.
Time frame: At day 0 before starting each intravenous perfusion.
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.
Time frame: At day 7 after each intravenous perfusion.
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.
Time frame: At day 14 after each intravenous perfusion.
Score variations of Fibromyalgia Impact Questionnaire
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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.
Time frame: At day 21 after each intravenous perfusion.
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.
Time frame: At day 28 after each intravenous perfusion.
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.
Time frame: At the beginning (minute zero) of each intravenous perfusion.
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.
Time frame: After 30 minutes of each intravenous perfusion.
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.
Time frame: After 60 minutes of each intravenous perfusion.
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.
Time frame: After 90 minutes of each intravenous perfusion.
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.
Time frame: After 120 minutes of each intravenous perfusion.
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.
Time frame: At the beginning (minute zero) of each intravenous perfusion.
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.
Time frame: After 30 minutes of each intravenous perfusion.
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.
Time frame: After 60 minutes of each intravenous perfusion.
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.
Time frame: After 90 minutes of each intravenous perfusion.
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.
Time frame: After 120 minutes of each intravenous perfusion.
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.
Time frame: At the beginning (minute zero) of each intravenous perfusion.
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.
Time frame: After 30 minutes of each intravenous perfusion.
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.
Time frame: After 60 minutes of each intravenous perfusion.
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.
Time frame: After 90 minutes of each intravenous perfusion.
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.
Time frame: After 120 minutes of each intravenous perfusion.
Variations of non-invasive blood pressure.
Measurement of variations of systolic and diastolic non-invasive blood pressure with upper arm cuff. Measurement in mmHg.
Time frame: At the beginning (minute zero) of each intravenous perfusion.
Variations of non-invasive blood pressure.
Measurement of variations of systolic and diastolic non-invasive blood pressure with upper arm cuff. Measurement in mmHg.
Time frame: After 30 minutes of each intravenous perfusion.
Variations of non-invasive blood pressure.
Measurement of variations of systolic and diastolic non-invasive blood pressure with upper arm cuff. Measurement in mmHg.
Time frame: After 60 minutes of each intravenous perfusion.
Variations of non-invasive blood pressure.
Measurement of variations of systolic and diastolic non-invasive blood pressure with upper arm cuff. Measurement in mmHg.
Time frame: After 90 minutes of each intravenous perfusion.
Variations of non-invasive blood pressure.
Measurement of variations of systolic and diastolic non-invasive blood pressure with upper arm cuff. Measurement in mmHg.
Time frame: After 120 minutes of each intravenous perfusion.
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.
Time frame: At the beginning (minute zero) of each intravenous perfusion.
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.
Time frame: After 30 minutes of each intravenous perfusion.
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.
Time frame: After 60 minutes of each intravenous perfusion.
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.
Time frame: After 90 minutes of each intravenous perfusion.
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.
Time frame: After 120 minutes of each intravenous perfusion.