ACTRN12621000328875已完成1 期
Sublingual Ketamine as Breakthrough Analgesia in Patients with Advanced Cancer -- A Feasibility Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 80 Years(—)
- 性别
- All
入选标准
- •1.Adult patients with diagnosis of advanced cancer
- •2.Weight >40 kg, and BMI between 18-40 kg•m-2
- •3.Moderate to severe pain associated with the cancer diagnosis requiring ongoing opioid analgesia at >60 mg of OMEDD (oral morphine equivalent daily dose)
- •4.Self-reporting sub-optimal pain control with current analgesia
- •5.Willingness to provide informed consent and willingness to participate and comply with the study requirements.
排除标准
- •1.Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study.
- •2.Participants who are receiving ketamine medication through any route of administration as part their treatment regimen.
- •3.Participants with a history of raised intra-cranial pressure, epilepsy, raised intra-ocular pressure, severe cardiac failure, or uncontrolled hypertension
- •4.Participants with a history of cognitive impairment which may interfere with their ability to understand the study requirements.
- •5.Participants with DSM-V diagnosis of psychotic disorders or dissociative disorders which may resemble the adverse effect of the study medication
- •6.The requirement of analgesia is expected to decrease following recruitment into the study.
- •7.Participants with life expectancy of less than six weeks
研究者
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