UnknownPhase 2ketamine
Ketamine and Neuropathic Pain
Sponsored by University Hospital, Clermont-Ferrand
NCT ID
NCT02467517
Target Enrollment
22 participants
Start Date
2015-11
Est. Completion
2018-04
About This Study
The primary outcome is to compare the analgesic efficacy of intravenous ketamine treatment to that of a placebo in patients with refractory neuropathic pain. The secondary outcomes are: 1. \- To compare the additive analgesic efficacy of prior administration of magnesium sulfate to that of placebo and ketamine only, on the effectiveness of intravenous ketamine treatment, 2. \- To study the evolution time of pain and analgesia after the intravenous administration of ketamine and placebo, 3. \- To study the correlation of the analgesic response to administered products respectively ketamine, ketamine and magnesium sulfate, placebo.
Conditions Studied
Interventions
- •Ketamine
- •Magnesium Sulfate
- •placebo : sodium chloride
Eligibility
Age:18 Years - N/A
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria: * Patient (s) are at least18 years old, with chronic pain (for more than 3 months), having the characteristics of a peripheral or central neuropathy, follow (s) at the Pain Clinic CHU Clermont-Ferrand and justifying the establishment of a therapeutic program including intravenous infusion of ketamine (as therapeutic test); * Patient (s) who had never received ketamine infusion under the care of their neuropathic pain; * History of illness compatible with an injury or disease of the somatosensory system; * Localized pain in an anatomical neuro territory; * Neurological examination shows sensory abnormalities, * The patients of childbearing potential must use effective contraception throughout the study; * For womens of childbearing age, they will be enrolled in the study after a negative urine pregnancy test; in case of suspicion of pregnancy, a blood pregnancy test should be performed; * Cooperation and willing to follow the study; * Acceptance to give written consent; * Affiliated to the French social security; * Inscription or acceptation of inscription in the national register of volunteers involved in trials. Exclusion Criteria: * Patient (s) who have received intravenous ketamine infusion; * Patients with one or many contraindication to ketamine administration: known hypersensitivity to ketamine in which one of the constituents of the product, uncontrolled high blood pressure, severe cardiac insufficiency; * Patients with one or many contraindication of magnesium sulfate administration: Patients with severe renal impairment; * Patients with one or many contraindication to administration of sodium chloride: water inflation, fluid retention; * Patients with a medical history and / or surgical judged by the investigator to be not consistent with the clinical trial; * Patients with drug treatments judged by the investigator to be not consistent with the clinical trial; * Pregnancy or lactation women; * Patient who participated in another clinical trial, located in exclusion period or received benefits \> 4500 euros during 12 months before the beginning of trial; * Patients with cooperation and understanding not to adhere strictly to the conditions provided in the clinical trial; * Patients receiving a measure of legal protection (guardianship…); * Patients are not affiliated to the System of the French Social Security
Study Locations (1)
CHU de Clermont-Ferrand
Clermont-Ferrand, France