The population selected is a spinal cord injury population with central neuropathic pain at the lesional or sub-lesion level, chronically (for more than three months) Adult, spinal cord injury (SCI), with <C5 involvement, presenting with chronic neuropathic pain ( DN), in lesional territory or under lesion. 2 groups: BM with DN with ulcer pressure (inflammation factor) BM with DN without ulcer pressure (without inflammation)
Conditions
Interventions
Trade Name: KETAMINE
KETAMINE PANPHARMA (50mg/5mL), Solution injectable IV-IM
Pharmaceutical Form: Solution for injection/infusion
Pharmaceutical form of the placebo: Solution for injection/infusion
Sponsors
Recherche et enseignement en douleur, anesthesie reanimation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adults speaking and understanding French - 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: - Participation in another interventional trial, or participation in another trial that has been interrupted for less than 3 months. - Patient under legal protection - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To show improved clinical efficacy of ketamine in chronic pain in patients with an inflammatory component;Secondary Objective: To explore the anti-inflammatory activity of ketamine through the Kynurenine pathway.;Primary end point(s): Decrease by more than 30% the intensity of neuropathic pain evaluated at the moment on a numerical scale of 10 points at H4. Comparison of groups two by two.;Timepoint(s) of evaluation of this end point: 4 hours after infusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): NPSI score at H1, H6, J1, J4, J7 Sub score of NPSI; H1, H6, J1, J4, J7 Depression score HADS J0, J1, J7 Painful surface evaluated on cartography H1, H4, J1, J4, J7 Blood tests in pre-administration of Ketamine and H6 after administration of: 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-1ß, IL-6, and TNF-a;Timepoint(s) of evaluation of this end point: Hours 1 and 4 Day 1 4 and 7 | — |
Countries
France
Contacts
Public ContactCyril QUEMENEUR
Recherche et enseignement en douleur, Anesthesie Réanimation
Outcome results
None listed