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

NCT ID: NCT04938713

Last Updated: 2021-08-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2022-09-30

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Ketamine 50 MG/ML

Intervention Type: DRUG

Intravenous Ketalar® 0,30 mg/kg in 1 hour.

Esketamine 25 MG/ML

Intervention Type: DRUG

Intravenous Vesierra® 0,15mg/kg in 1 hour.

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.

Group Type: OTHER

Ketamine 50 MG/ML

Intervention Type: DRUG

Intravenous Ketalar® 0,30 mg/kg in 1 hour.

Esketamine 25 MG/ML

Intervention Type: DRUG

Intravenous Vesierra® 0,15mg/kg in 1 hour.

Interventions

Ketamine 50 MG/ML

Intravenous Ketalar® 0,30 mg/kg in 1 hour.

Intervention Type: DRUG

Esketamine 25 MG/ML

Intravenous Vesierra® 0,15mg/kg in 1 hour.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Liege

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Charleroi

OTHER

Sponsor Role: lead

Responsible Party

Brice Constant, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brice Constant, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Universitaire de Charleroi

Locations

CHU de Charleroi

Lodelinsart, Hainaut, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Brice Constant, MD

Role: CONTACT

briceconstant@hotmail.com

0032477504934

Romain Dehavay, MD

Role: CONTACT

romain.dehavay@gmail.com

0032476684876

Facility Contacts

Brice JD Constant, MD

Role: primary

briceconstant@hotmail.com

0032477504934

Romain Dehavay, MD

Role: backup

romain.dehavay@gmail.com

0032476684876

Other Identifiers

KESK-FIQ

Identifier Type: -

Identifier Source: org_study_id