Low-Dose Ketamine Versus Morphine for Moderate to Severe Pain in the Emergency Department Geriatric Population: A Prospective, Randomized, Double-Blind Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduction of Pain Score at 30 Minutes
研究概览
简要总结
This research project is geared towards geriatric analgesia in the Emergency Department (ED) with a goal of reducing the administration of opioid pain medications to elderly patients, thereby avoiding the commonly occurring, severe side effects associated with such medications, including hypotension, respiratory depression, altered mental status, delirium, as well as nausea/vomiting and constipation.
The primary outcome of the study will be difference in pain score from baseline to 30 minutes post-medication administration.
This project has the potential to change and modify the ED approach to geriatric analgesia by virtue of minimizing the use of opioid administration in elderly patients. T
详细描述
Elderly patients are making up a greater proportion of the New York State population every year as the nation's overall population continues to age at a rapid pace. Acute and chronic pain conditions are very common in the geriatric population and it is well recognized that pain is undertreated in the elderly. Complicating this important public health problem is that changes in physiology that occur in the elderly, such as cognitive decline and impaired ability of the liver and kidney to metabolize medications, render opioid administration particularly dangerous in the geriatric population. Adverse side effects and increased health care utilization are well known hazards associated with opioid use in the elderly.
Therefore, development of pain management strategies that include non-opioid pain treatment modalities has the potential to have a major impact on the health and well-being of New Yorkers. This study undertakes a novel strategy intended to reduce opioid consumption in the elderly.
This research project will evaluate the analgesic feasibility and safety of short infusion of subdissociative dose of intravenous ketamine compared with short infusion of intravenous morphine for controlling pain in ED patients 65 years of age and older, laying the groundwork for ketamine to become a safe and viable alternative to opioids in managing geriatric pain in the ED. The significance of this project being done at Maimonides Medical center is to lay the foundation to providing safer analgesia in geriatric ED patients and moving towards an eventual goal of an "opioid-free" ED.
Methods:
Study Design:
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
- 65 Years 至 120 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ED patients; 65 years of age and older; abdominal, flank, back, traumatic chest, neck or musculoskeletal pain; capacity to give verbal or written consent.
排除标准
- •ED patients <65 years old; altered mental status; presenting with headache, non-traumatic chest pain; allergy to morphine or ketamine; weight <40kg or >115kg, unstable vital signs (systolic blood pressure <90 or >180 mmHg; heart rate <5 or >150 beats per minute; and respirations <8 or >30 per minute), and past medical history of severe renal or hepatic insufficiency, alcohol or drug abuse or psychiatric illness; Patients with BMI>40; severe COPD
研究组 & 干预措施
Morphine Group
intravenous Morphine given at 0.1 mg/kg as intravenous infusion (10 min) with a maximum dose of 10 mg.
干预措施: Morphine (Drug)
Ketamine Group
Ketamine administered in sub-dissociative doses 0.3 mg/kg as a intravenous infusion (10 min)
干预措施: Ketamine (Drug)
结局指标
主要结局
Reduction of Pain Score at 30 Minutes
时间窗: 30 minutes
The primary outcome will be the comparative reduction of NRS pain scores between the 2 groups at 30 minutes. The NRS Pain scale ranges from 0 to 10 (0 being no pain at all to 10 being very severe pain; 5 is moderate pain)
次要结局
未报告次要终点
研究者
Antonios Likourezos
Research Manager
Maimonides Medical Center