Ketamine's Efficiency in the Treatment of Chronic Pain: Kynurenin Pathway
NCT ID: NCT03513822
Last Updated: 2018-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
48 participants
INTERVENTIONAL
2018-02-16
2018-11-30
Brief Summary
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Study design: Interventional randomized placebo-controlled clinical trial.
Main goals:
1. To show a better clinical efficacy of ketamine in chronic pain in patients with an inflammatory component.
2. Explore the anti-inflammatory activity of ketamine through the Kynurenine pathway.
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Detailed Description
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Study design: Interventional randomized placebo-controlled clinical trial.
Main goals:
1. To show a better clinical efficacy of ketamine in chronic pain in patients with an inflammatory component.
2. Explore the anti-inflammatory activity of ketamine through the Kynurenine pathway.
Population Adult, medullary injured (BM), with chronic neuropathic pain (DN). 4 groups: BM with DN with bedsore Ketamine Group versus Placebo Group BM with DN without bedsore group Ketamine versus Placebo Group
Intervention Ketamine infusion 1 mg / kg IVSE over two hours versus Nacl perfusion 0.9%
 Primary judgment criterion Decrease by more than 30% the intensity of neuropathic pain evaluated at the moment on a numerical scale of 10 points between H0 and H4. Comparison of groups two by two.
Secondary judgment criterions:
NPSI score (Neuropathic pain symptom inventory) at H1, H4, D1, D4, J7 Sub score of NPSI; H1, H4, J1, J4, J7 Depression Scale HADS (Hospital Anxiety Depression Scale) J0, J1, J7 Plasma serotonin (5-HT) kynurenine (KYN), indoleamine 2,3-dioxygenase 1 (IDO1) activity (KYN / TRP ratio), kynurenic acid ( KA) and quinolinic acid (QA), as well as 3 proinflammatory cytokines IL-1β, IL-6, and TNF-α before perfusion and H4 perfusion.
In parallel blood samples will be collected to study the activation of the kynurenine pathway in response to inflammation due to a pressure ulcer.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Both products will be prepared by an SSPI nurse who opens the envelope, the nurse does not participate in the study, the patient assessment investigator as well as the patient will remain blind about the administration of the product. Each syringe will be labeled for each patient with a special label without indication of the product The outcomes assessor, investigator and participant are blinded.
Study Groups
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Chronic neuropathic pain and bedsore Ketamine group
Spinal cord injury population with central neuropathic pain at the lesional or sub-lesion level, chronically (for more than three months).
Patients medullary wounded with chronic pain and ulcer pressure (inflammation factor).
Midazolam 1mg before infusion. KETAMINE INFUSION IVSE 1mg/kg during 2 hours (0,5mg/kg/h). Preparation of 100mg in fifty cc, syringe with 2mg/ml. Rate of administration: Speed = Patient weight divided by four.
Maximum 100mg. One and only perfusion.
Ketamine 10 MG/ML
Ketamine infusion 1mg/kg with electric syringe during 2 hours.
Midazolam 1 MG/ML
Bolus of Midazolam 1mg before each perfusion.
Chronic neuropathic pain and bedsore Placebo group
Spinal cord injury population with central neuropathic pain at the lesional or sub-lesion level, chronically (for more than three months).
Patients medullary wounded with chronic pain and ulcer pressure (inflammation factor).
Midazolam 1mg before infusion. Sodium chloride infusion IVSE during 2 hours. Rate of administration : Speed = patient weight divided by four.
One and only perfusion.
Placebos
Sodium chloride infusion with the same rate, electric syringe during 2 hours.
Midazolam 1 MG/ML
Bolus of Midazolam 1mg before each perfusion.
Chronic neuropathic pain without bedsore Ketamine group
Spinal cord injury population with central neuropathic pain at the lesional or sub-lesion level, chronically (for more than three months).
Patients medullary wounded with chronic pain and no ulcer pressure (no inflammation factor).
Midazolam 1mg before infusion. KETAMINE INFUSION IVSE 1mg/kg during 2 hours (0,5mg/kg/h). Preparation of 100mg in fifty cc, syringe with 2mg/ml. Rate of administration: Speed = Patient weight divided by four.
Maximum 100mg. One and only perfusion.
Ketamine 10 MG/ML
Ketamine infusion 1mg/kg with electric syringe during 2 hours.
Midazolam 1 MG/ML
Bolus of Midazolam 1mg before each perfusion.
Chronic neuropathic pain without bedsore Placebo group
Spinal cord injury population with central neuropathic pain at the lesional or sub-lesion level, chronically (for more than three months).
Patients medullary wounded with chronic pain and no ulcer pressure (no inflammation factor).
Midazolam 1mg before infusion. Sodium chloride infusion IVSE during 2 hours. Rate of administration : Speed = patient weight divided by four.
One and only perfusion.
Placebos
Sodium chloride infusion with the same rate, electric syringe during 2 hours.
Midazolam 1 MG/ML
Bolus of Midazolam 1mg before each perfusion.
Interventions
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Ketamine 10 MG/ML
Ketamine infusion 1mg/kg with electric syringe during 2 hours.
Placebos
Sodium chloride infusion with the same rate, electric syringe during 2 hours.
Midazolam 1 MG/ML
Bolus of Midazolam 1mg before each perfusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* presenting chronic neuropathic pain as defined by IASP
* Painful intensity\> or = to 6/10 during the week preceding the inclusion - Medullary lesion, whatever the origin (traumatic, degenerative, tumoral, postoperative), responsible for paraplegia in a chronic state.
* Able to give informed consent, after clear, fair and appropriate information
* Having given their consent by a written consent signature.
Exclusion Criteria
* Participation in another interventional trial, or participation in another trial.
* Patient unable to give consent.
* Pregnancy or breastfeeding
* Refusal to sign the consent
* Cardiovascular diseases associated in particular with disorders of rhythm and severe cardiac insufficiency, coronary insufficiency, discovered on examination, on ECG or by biological balance or known. - unstabilized HTA\> 180/100 mmHg
* Severe hepatic and / or renal hepatic insufficiency.
18 Years
ALL
No
Sponsors
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Hôpital Raymond Poincaré
OTHER
Hopital Lariboisière
OTHER
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Fondation Apicil
OTHER
Hospital Ambroise Paré Paris
OTHER
Recherche Clinique Paris Descartes Necker Cochin Sainte Anne
OTHER
Redar
OTHER
Responsible Party
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Principal Investigators
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Didier Bouhassira, Md, PhD
Role: STUDY_CHAIR
INSERM U987
Locations
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Raymond Poincaré Hospital
Garches, Hauts De Seine, France
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2017-003930-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
protocole ph-03-2018
Identifier Type: REGISTRY
Identifier Source: secondary_id
REDAR
Identifier Type: -
Identifier Source: org_study_id
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