NCT02467517Unknown2 期
Ketamine and Neuropathic Pain
University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2015年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Numerical rating scale (NRS)
研究概览
简要总结
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:
-
- 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,
-
- To study the evolution time of pain and analgesia after the intravenous administration of ketamine and placebo,
-
- To study the correlation of the analgesic response to administered products respectively ketamine, ketamine and magnesium sulfate, placebo.
详细描述
Description of the study:
Single-center clinical trial, controlled, randomized, double-blind, crossover design, against inactive placebo.
Each patient will receive successively the 3 products (ketamine / placebo, ketamine / magnesium sulfate, placebo / placebo) follows a predeter randomization list, with a wash-out period between each administration.
Visit 1
-Inclusion visit, signature of informed consent form, clinical examination and fill questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
INTRAVENOUS KETAMINE
Experimental
干预措施: Ketamine (Drug)
INTRAVENOUS KETAMINE
Experimental
干预措施: Magnesium Sulfate (Drug)
结局指标
主要结局
Numerical rating scale (NRS)
时间窗: at day 1 and for a period of 5 weeks (35 days).
次要结局
- Impact on quality of life(at day 1)
- Impact on mood(at day 1)
- Impact on sleep(at day 1)
- Intensity of the average(at day 1)
- Intensity of maximum daily pain(at day 1)
研究者
研究点 (1)
Loading locations...
相似试验
撤回
4 期
Ketamine in Colorectal SurgeryAcute PainPain, PostoperativeColorectal SurgeryNCT02785003Medical College of Wisconsin
Enrolling By Invitation
4 期
Ketamine Infusion for Neuropathic Pain in Brachial Plexus InjuriesBrachial Plexus InjuryNCT04933149Mayo Clinic100
已完成
不适用
Use of Ketamine in Severe Pain SyndromesPain, IntractablePain, ChronicPain SyndromePain MeasurementNCT06537375Erasme University Hospital89
尚未招募
不适用
Prospective Evaluation of the Clinical Utility of Ketamine in Pain Desensitisation in Chronic PaiComplex Regional Pain SyndromeAnaesthesiology - Pain managementNeurological - Multiple sclerosisMultiple SclerosisACTRN12613000022763Monash University60
招募中
3 期
Comparison of Ketamine, Tramadol, and Ondansetron in shiver controllingIRCT20110425006281N2Rasht University of Medical Sciences508