ケタミンと神経因性疼痛 (KETAPAIN)
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.
調査の概要
詳細な説明
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.
For women of childbearing age a pregnancy test will be performed.The pain will be measured by a numerical scale.
The pain will be evaluated by scoring on a numerical scale. A booklet for monitoring analgesic concomitant medication and overall pain on a numerical scale will be given to the patient 14 days before the programmed infusion.
Visit 2 : Period 1 Day 0
Clinical examination, return of booklet completed by patient and fill questionnaires.
The pain will be evaluated by scoring on a numerical scale before and after the infusion.
For women of childbearing age a pregnancy test will be performed. Treatment allocation period follows a predeter randomization list. At the end of the infusion, a booklet for monitoring will be given to patients for the following weeks in order to score their overall pain until the next study period.
The output of the hospital patient (CPC / CETD) after each treatment will be authorized by the investigator.
Wash-out period: 5 weeks.
Phone call 1 (Day 1):
Patients will be called by phone to collect adverse events and concomitant medications. If necessary, the patients should return to consult the CPC / CETD for a clinical examination.
Patients will be called the week before their scheduled visit, if at that time their spontaneous pain is still low, according to the opinion of the investigator, the infusion visit will be shifted to allow the pain level back its basal level.
Visit 3 : Period 2 : Day 36 +/- 3 days
Same of period 1.
Phone call 2 J 37 +/- 3 days:
Same of phone call 1.
Visit 4 : Period 3 : Day 72 +/- 3 days
Same of period 1
Phone call 3 J 73 +/- 3 days:
Same of phone call 1.
Visit 5 : Day 108 +/- 3 days
Clinical examination, return of booklet completed by patient and fill questionnaires.
The pain will be evaluated by scoring on a numerical scale For women of childbearing age a pregnancy test will be performed. This visit is the end of the study.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
-
Clermont-Ferrand、フランス、63003
- CHU de Clermont-Ferrand
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：静脈内ケタミン
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
数値評価尺度 (NRS)
時間枠：1 日目と 5 週間 (35 日) の期間。
|
1 日目と 5 週間 (35 日) の期間。
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Intensity of the average
時間枠：at day 1
|
Intensity of the average daily pain evaluated by a numerical rating scale (NRS) assessed using a booklet |
at day 1
|
|
Intensity of maximum daily pain
時間枠：at day 1
|
Intensity of maximum daily pain evaluated by a numerical rating scale (NRS) assessed using a booklet, |
at day 1
|
|
Impact on quality of life
時間枠：at day 1
|
Impact on quality of life, mood and sleep assessed by questionnaires. |
at day 1
|
|
Impact on mood
時間枠：at day 1
|
Impact on quality of life, mood and sleep assessed by questionnaires. |
at day 1
|
|
Impact on sleep
時間枠：at day 1
|
Impact on quality of life, mood and sleep assessed by questionnaires. |
at day 1
|
協力者と研究者
捜査官
- 主任研究者：Gisèle PICKERING、University Hospital, Clermont-Ferrand
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (推定)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。