Single-dose Ketamine to Reduce Pain Severity, Depressive Symptoms and the Need for Opiates Both During and After Emergency Department Care
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- Pain Intensity in the ED
研究概览
简要总结
In this proposal, the investigators will determine if a single dose of intravenous (IV) ketamine (in combination with midazolam) reduces pain severity, depressive symptoms and need for opiate analgesics both in the ED and in the acute recovery period after ED discharge. The investigators will compare the ketamine arm to an active placebo-controlled arm (with midazolam).
详细描述
The investigators will enroll 120 medically stable adult patients who present to two Emergency Departments with a chief complaint of acute pain.
The investigators will randomly assign subjects using a blocked randomization schedule to either: 1) a single dose of IV ketamine (0.3 mg.kg) + midazolam, or 2) placebo + midazolam. ED providers and patients will be blind to treatment allocation.
All participants will complete measures of pain and mood scores every 30 minutes, and the investigators will record any analgesics administered in the ED until discharge. At 7-days and 14-days post- discharge, the investigators will measure summary reports of pain severity, mood, and analgesic medication used.
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
- •Adults between the ages of 18-65
- •A chief complaint of painful condition (pain score ≥ 5 on the numeric rating scale [NRS] from 0-10 with anchors of 0 = "no pain" and 10 = "worst pain imaginable")
- •Expected to be in the ED for at least 2 hours
排除标准
- •Non-English speaking
- •Not medically suitable for ketamine per treating MD (e.g. medical condition where ketamine is contraindicated); ketamine or midazolam may be unsafe (e.g., known sensitivity, glaucoma, or other concerns)
- •Not alert and oriented
- •Active psychosis, self-injury, suicidal/homicidal intentions on initial evaluation by treating team
- •Seeking treatment due to a mental health or substance use disorder
- •History of chronic opioid use
- •Prescribed opioid use within the past 24 hours
- •Any use of recreational narcotics throughout lifetime
- •Sensitivity or allergy or intolerance to ketamine, opioids, and/or benzodiazepines
- •Weight > 170kg (375 lbs)
- •Current neurological disease (e.g., multiple sclerosis, stroke, brain tumor, seizure disorder, etc.)
研究组 & 干预措施
Experimental Arm
Participants will be assigned to receive a single dose of IV ketamine (0.3 mg.kg) + midazolam
干预措施: Ketamine (Drug)
Experimental Arm
Participants will be assigned to receive a single dose of IV ketamine (0.3 mg.kg) + midazolam
干预措施: Midazolam (Drug)
Active Placebo Arm
Participants will be assigned to receive a single dose of IV placebo + midazolam
干预措施: Midazolam (Drug)
Active Placebo Arm
Participants will be assigned to receive a single dose of IV placebo + midazolam
干预措施: Placebo (Drug)
结局指标
主要结局
Pain Intensity in the ED
时间窗: Pain intensity rating in the ED at 1-hour post-study drug administration
Pain Numeric Rating Scale (PNRS)- this item is anchored to pain intensity "right now" on a scale from 0(no pain)-10 (worst pain imaginable)
次要结局
- Pain Intensity at Follow-Up(Pain Intensity at 1-week post-ED Discharge)
研究者
Maria Pacella
Assistant Professor
University of Pittsburgh