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Comparison of Ketamine and Esketamine in Patients Suffering From Fibromyalgia Syndrome. (KESK-FIQ)

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ClinicalTrials.gov Identifier: NCT04938713
Recruitment Status : Recruiting
First Posted : June 24, 2021
Last Update Posted : August 27, 2021
Sponsor:
Collaborator:
Centre Hospitalier Universitaire de Liege
Information provided by (Responsible Party):
Brice Constant, MD, Centre Hospitalier Universitaire de Charleroi

Tracking Information
First Submitted Date  ICMJE June 17, 2021
First Posted Date  ICMJE June 24, 2021
Last Update Posted Date August 27, 2021
Actual Study Start Date  ICMJE July 1, 2021
Estimated Primary Completion Date May 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2021)
  • Score variations of Fibromyalgia Impact Questionnaire [ Time Frame: 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.
  • Score variations of Fibromyalgia Impact Questionnaire [ Time Frame: At day 7 after 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.
  • Score variations of Fibromyalgia Impact Questionnaire [ Time Frame: At day 14 after 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.
  • Score variations of Fibromyalgia Impact Questionnaire [ Time Frame: At day 21 after 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.
  • Score variations of Fibromyalgia Impact Questionnaire [ Time Frame: At day 28 after 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2021)
  • Heart rate disturbances after intravenous perfusion of Ketamine or Esketamine [ Time Frame: At the beginning (minute zero) of each intravenous perfusion. ]
    Measurement of heart rate in Pain clinic during intravenous perfusion. Measurement in beat per minute.
  • Heart rate disturbances after intravenous perfusion of Ketamine or Esketamine [ Time Frame: After 30 minutes of each intravenous perfusion. ]
    Measurement of heart rate in Pain clinic during intravenous perfusion. Measurement in beat per minute.
  • Heart rate disturbances after intravenous perfusion of Ketamine or Esketamine [ Time Frame: After 60 minutes of each intravenous perfusion. ]
    Measurement of heart rate in Pain clinic during intravenous perfusion. Measurement in beat per minute.
  • Heart rate disturbances after intravenous perfusion of Ketamine or Esketamine [ Time Frame: After 90 minutes of each intravenous perfusion. ]
    Measurement of heart rate in Pain clinic during intravenous perfusion. Measurement in beat per minute.
  • Heart rate disturbances after intravenous perfusion of Ketamine or Esketamine [ Time Frame: After 120 minutes 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. [ Time Frame: 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 pain. [ Time Frame: After 30 minutes 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 pain. [ Time Frame: After 60 minutes 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 pain. [ Time Frame: After 90 minutes 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 pain. [ Time Frame: After 120 minutes 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. [ Time Frame: 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 Visual Analogue Scale for nausea. [ Time Frame: After 30 minutes 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 Visual Analogue Scale for nausea. [ Time Frame: After 60 minutes 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 Visual Analogue Scale for nausea. [ Time Frame: After 90 minutes 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 Visual Analogue Scale for nausea. [ Time Frame: After 120 minutes 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. [ Time Frame: 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 non-invasive blood pressure. [ Time Frame: After 30 minutes of each intravenous perfusion. ]
    Measurement of variations of systolic and diastolic non-invasive blood pressure with upper arm cuff. Measurement in mmHg.
  • Variations of non-invasive blood pressure. [ Time Frame: After 60 minutes of each intravenous perfusion. ]
    Measurement of variations of systolic and diastolic non-invasive blood pressure with upper arm cuff. Measurement in mmHg.
  • Variations of non-invasive blood pressure. [ Time Frame: After 90 minutes of each intravenous perfusion. ]
    Measurement of variations of systolic and diastolic non-invasive blood pressure with upper arm cuff. Measurement in mmHg.
  • Variations of non-invasive blood pressure. [ Time Frame: After 120 minutes 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. [ Time Frame: 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.
  • Variations of pulse Oxygen saturation. [ Time Frame: After 30 minutes 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.
  • Variations of pulse Oxygen saturation. [ Time Frame: After 60 minutes 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.
  • Variations of pulse Oxygen saturation. [ Time Frame: After 90 minutes 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.
  • Variations of pulse Oxygen saturation. [ Time Frame: After 120 minutes 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Ketamine and Esketamine in Patients Suffering From Fibromyalgia Syndrome.
Official Title  ICMJE Comparison of Ketamine and Esketamine in Ambulatory Patients Treated for Fibromyalgia Syndrome in Pain Clinic. A Single-center, Prospective, Randomized, Double-blind, Crossover Study.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia
Intervention  ICMJE
  • Drug: Ketamine 50 MG/ML
    Intravenous Ketalar® 0,30 mg/kg in 1 hour.
  • Drug: Esketamine 25 MG/ML
    Intravenous Vesierra® 0,15mg/kg in 1 hour.
Study Arms  ICMJE
  • Active Comparator: AB group

    If A = Ketamine and B = Esketamine, each patient included in the study will be randomized in a sequence of administration of the two products. The AB sequence consists of patients starting with intravenous Ketamine 0,3 mg/kg in 1 hour (2 infusions separated by 6 weeks; Period 1) and continuing with intravenous Esketamine 0,15 mg/kg in 1 hour (2 infusions separated by 6 weeks; Period 2). Each patient will be monitored during the IV perfusion, and then, the next hour.

    The patient will receive a total of two infusions of Ketamine and two infusions of Esketamine. Each patient will be his own witness because having received the two products without knowing which he started with. A "wash-out" period of one week will be observed between the two administration periods to avoid so-called "carry-over" effects according to which the administration of the first drug could influence the effect of the second drug administered.

    Interventions:
    • Drug: Ketamine 50 MG/ML
    • Drug: Esketamine 25 MG/ML
  • BA group

    If A = Ketamine and B = Esketamine, each patient included in the study will be randomized in a sequence of administration of the two products. The BA sequence consists of patients starting with intravenous Esketamine 0,15 mg/kg in 1 hour (2 infusions separated by 6 weeks; Period 1) and continuing with intravenous Ketamine 0,3 mg/kg in 1 hour (2 infusions separated by 6 weeks; Period 2). Each patient will be monitored during the IV perfusion, and then, the next hour.

    The patient will receive a total of two infusions of Esketamine and then two infusions of Ketamine. Each patient will be his own witness because having received the two products without knowing which he started with. A "wash-out" period of one week will be observed between the two administration periods to avoid so-called "carry-over" effects according to which the administration of the first drug could influence the effect of the second drug administered.

    Interventions:
    • Drug: Ketamine 50 MG/ML
    • Drug: Esketamine 25 MG/ML
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 17, 2021)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2022
Estimated Primary Completion Date May 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Brice Constant, MD 0032477504934 briceconstant@hotmail.com
Contact: Romain Dehavay, MD 0032476684876 romain.dehavay@gmail.com
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04938713
Other Study ID Numbers  ICMJE KESK-FIQ
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: IPD will be available according to reasonable demands.
Current Responsible Party Brice Constant, MD, Centre Hospitalier Universitaire de Charleroi
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Centre Hospitalier Universitaire de Charleroi
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Centre Hospitalier Universitaire de Liege
Investigators  ICMJE
Principal Investigator: Brice Constant, MD Centre Universitaire de Charleroi
PRS Account Centre Hospitalier Universitaire de Charleroi
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP