Ketamine and Neuropathic Pain

• Status: Unknown status
• Trial end date: 2018-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Clermont-Ferrand
• Treatments: Ketamine; Magnesium Sulfate

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