Efficacy and Adverse Events of Morphine and Fentanyl in an Aeromedical Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Mean Change in Numeric Pain Score (NPS) From First to Last Dose
研究概览
简要总结
The study is exempt from informed consent by the MetroHealth Medical Center institutional review board (IRB), because two standards of care are used and there is no increased clinical risk to the patient due to the study. The researchers randomize either fentanyl or morphine to be given to trauma patients and record how their pain scale is treated along with observing for adverse events. They are looking to see if the hypothesized benefits of fentanyl (which is much more expensive than morphine) actually exist.
详细描述
Periodic reports are made to the IRB.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Trauma patient
- •Able to speak/communicate a pain scale
排除标准
- •Initially or any time hypotensive
研究组 & 干预措施
Arm C Morphine
Morphine given to trauma patients transported by helicopter
干预措施: either fentanyl or morphine (Drug)
Arm D Fentanyl
Fentanyl given to trauma patients transported by helicopter
干预措施: either fentanyl or morphine (Drug)
结局指标
主要结局
Mean Change in Numeric Pain Score (NPS) From First to Last Dose
时间窗: Medication was administered over a mean transport time of 37 minutes in the Morphine group and 43 minutes in the Fentanyl group.
Mean difference in the numeric pain score (NPS) from the first dose to the final dose of medication administered. A significant mean pain score change is defined as greater than or equal to 2 Numeric Pain Score (NPS) 0-10, 0 Least pain, 10 most pain
次要结局
- Recording of Instance of Narcotic Side Effects.(Groups were observed a mean of 37 minutes in the Morphine Group and a mean of 43 minutes in the Fentanyl group for side effects.)
研究者
Charles Emerman, MD
Professor of Emergency Medicine, Case Western Reserve SOM
MetroHealth Medical Center