DRKS00026775招募中2 期
Randomized controlled trial of the use of intranasal midazolam for the treatment of terminal agitation in palliative care patients - MinT
niversität Heidelberg0 个研究点目标入组 60 人开始时间: 2022年7月7日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Patient in a palliative stage of disease.
- •-Age = 18 years
- •-Personal information of the patient by one of the investigators.
- •-Ability of the participant to understand the nature and scope of the clinical trial
- •-Written informed consent of the patient
- •-Diagnosis final phase
- •-Diagnosis of terminal agitation
- •-RASS-PAL Score > 0
排除标准
- •-Diseases affecting nasal absorption.
- •-Hypersensitivity to midazolam or to any other component/excipient of the study medication
- •-Parallel use of strong CYP 3A4 inducers or CYP 3A4 inhibitors
- •-Other causes are responsible for the observed agitation symptomatology and can be treated causally
- •-A non-drug therapy is effective and leads to improvement of the restlessness symptoms
- •-Pregnant and breastfeeding women
研究者
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