UnknownPhase 3ketamine

Ketamine's Efficiency in the Treatment of Chronic Pain: Kynurenin Pathway

NCT ID

NCT03513822

Target Enrollment

48 participants

Start Date

2018-02-16

Est. Completion

2018-11

About This Study

The kynurenine pathway is involved in hyperalgesia. This pathway is activated by inflammation. Ketamine would interact with the kynurenine pathway and inflammation. Our working hypotheses are: the clinical effects of ketamine on neuropathic pain are greater in the presence of systemic inflammation and the mechanism of action involves an interaction on the kynurenine pathway. 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.

Conditions Studied

NeuralgiaChronic PainInflammation

Interventions

•Ketamine 10 MG/ML
•Placebos
•Midazolam 1 MG/ML

Eligibility

Age:18 Years - N/A

Healthy Volunteers:No

View full eligibility 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.

Exclusion Criteria:

* Hypersensitivity to ketamine or any of its components
* 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.

Study Locations (1)

Raymond Poincaré Hospital