EUCTR2015-000202-20-FR进行中（未招募）1 期
Effect and tolerance of ketamine's subcutaneous bolus during painfulcare, refractory of bedsore, ulcer, vascular wound care in palliative careunits. - KETAREF
Groupement des Hôpitaux de l’Institut Catholique de Lille (GHICL)0 个研究点开始时间: 2015年6月19日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Patients of age (=18 years old), hospitalized in palliative care units
- •-Conscious or presenting disturbed consciousness but for whom the Rudkin score is = 4 (eyes closed, response to light tactical stimulation)
- •-For whom a palliative care is acted
- •-No matter the progression and prognostic status
- •-After the information is given to the patient (with the notification form given) and the written consent form is retrieved and when the state of cognition and vigilance allows it. In case of cognitive and consciousness disturbance, after informing and retrieving the written consent form from the patient’s trusted person, or a relative by default, for patients under guardianship after being informed and giving a consent form written by the legal representative.
- •-Evened out on an analgesia level, without care
- •-Who has not received ketamine for 60 days before inclusion no matter the indications
- •-For whom bedsore, ulcer or vascular injuries have appeared and continue to be painful despite the administration of opioid bolus with the painful evaluation regarding the visual analogic scale (EVA) = 5/10, or regarding the evaluation of the Algoplus pain behavior scale = 2, or for whom the opioid treatment cannot be administered due to the presence of adverse side effects (drowsiness, confusion, nausea, vomiting, respiratory depression…)
- •-And for whom caring under Entonox (a medical analgesic gas which is a mix of nitrous oxide and oxygen) is inefficient or not compatible.
- •-Lack of easy venous access
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Contraindication of Ketamine in case of anesthesia (AMM) : allergy, porphyria
- •-Late stage heart failure
- •-Intracranious hypertension
- •-Acute heart attack phase
- •-Unstable psychosis
- •-Presence of agitation
- •-Pregnant woman
- •-Patient with no affiliation to a social security system
- •-Contraindication of Midazolam: known hypersensitivity to benzodiazepines or any other know excipient of the product, acute respiratory depression
研究者
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