Feasibility Study Comparing a Ketamine and Midazolam Infusion to a Midazolam-Only Infusion for Complex Regional Pain Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in investigator masking
研究概览
简要总结
This study will assess the feasibility of administering ketamine plus midazolam or midazolam alone, when infused over 5 days in an outpatient setting, to adults with complex regional pain syndrome (CRPS).
详细描述
Subanesthetic ketamine infusions are a potentially impactful treatment for chronic refractory pain, but the acute psychoactive effects of ketamine complicate successful masking in randomized trials. Multi-day ketamine infusions have produced long-lasting, but not permanent, remission of symptoms in complex regional pain syndrome (CRPS), a chronic and often debilitating neuropathic pain condition that can affect one or more limbs. In this feasibility study, 4 adults with CRPS will be randomized to receive either ketamine and midazolam or midazolam-only, infused over 5 days in an outpatient setting. The objectives of this feasibility study are:
- Assess whether the recruitment and retention rate observed in this feasibility study can support a larger clinical trial.
- Evaluate whether participants can adhere to study procedures.
- Determine whether midazolam, when given alone as an intravenous (IV) infusion, can be used as an active placebo that is well-tolerated, practical, and believable compared to a ketamine plus midazolam infusion.
- Gather preliminary data on clinically-relevant outcomes for CRPS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ketamine and Midazolam
Participants will receive intravenous infusions of ketamine and midazolam for 4 hours each day, over 5 consecutive days, in an outpatient setting.
干预措施: Ketamine (Drug)
Ketamine and Midazolam
Participants will receive intravenous infusions of ketamine and midazolam for 4 hours each day, over 5 consecutive days, in an outpatient setting.
干预措施: Midazolam (Drug)
Midazolam and Saline
Participants will receive intravenous infusions of midazolam and normal saline for 4 hours each day, over 5 consecutive days, in an outpatient setting.
干预措施: Midazolam (Drug)
Midazolam and Saline
Participants will receive intravenous infusions of midazolam and normal saline for 4 hours each day, over 5 consecutive days, in an outpatient setting.
干预措施: Normal Saline (Drug)
结局指标
主要结局
Change in investigator masking
时间窗: During intervention administration
Investigators administering and monitoring the drug infusions will be asked to guess the participant's assigned treatment in a forced binary choice and to rate their level of confidence on a scale from 0 to 100%.
Number and proportion of patients who can undergo the steps of recruitment, informed consent, enrollment, and randomization
时间窗: 2 months after the study opens for enrollment
Out of all patients identified as potentially eligible for the study based on chart review, we will measure the number and proportion who can undergo the steps of recruitment, informed consent, enrollment, and randomization during a 2-month period.
Number and types of adverse events
时间窗: 8 weeks after receiving intervention
Adverse events will be elicited from the participant in a brief, open-ended structured interview.
Change in participant masking
时间窗: During intervention administration
Participants will be asked to guess their assigned treatment in a forced binary choice and to rate their level of confidence on a scale from 0 to 100%.
Number and proportion of randomized participants who remain in the study until the last follow-up timepoint
时间窗: 8 weeks after receiving intervention
Out of all patients who were randomized to a treatment group, we will measure the number and proportion who remain in the study until their last follow-up timepoint.
次要结局
- Pain interference(Baseline, and weekly for 8 weeks after the end of treatment)
- Anxiety(Baseline, and weekly for 8 weeks after the end of treatment)
- Sleep disturbance(Baseline, and weekly for 8 weeks after the end of treatment)
- Pain catastrophizing(Baseline, and weekly for 8 weeks after the end of treatment)
- Pain intensity(Baseline, daily during treatment (5 days), and daily for 8 weeks after treatment)
- Number of painful body regions(Baseline, and weekly for 8 weeks after the end of treatment)
- Treatment expectancies(Baseline, and daily during treatment (5 days))
- Physical function(Baseline, and weekly for 8 weeks after the end of treatment)
- Depression (PHQ-9)(Baseline, and weekly for 8 weeks after the end of treatment)
- Depression (PROMIS)(Baseline, and weekly for 8 weeks after the end of treatment)
- Chronic pain acceptance(Baseline, and weekly for 8 weeks after the end of treatment)
- Patient global impression of change(Weekly for 8 weeks after the end of treatment)
研究者
Theresa Lii
Principal Investigator
Stanford University