Patient Input Monitoring of Pain in the Emergency Room: Novel Electronic Log (PIMPERNEL). A Randomised Controlled Trial of an Electronic Pain Score Display in Adults in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Pain reported by the patient:11 point numerical pain scale
研究概览
简要总结
Can a novel electronic display of pain be successfully used in the emergency department and does it (1) change analgesic prescription and (2) change amount of pain experienced? Pain is a common symptom in emergency care. As patients are seldom reassessed, staff may not be aware of pain. Currently, members of nursing or medical staff need to ask patients about their pain and record it manually using a visual analogue scale from 0-10.
The new electronic display uses buttons to represent a pain scale from 0 (no pain) to 10 (worst pain). Patients will select the number that best corresponds to their pain every 15 minutes. In the experimental group, the score will be displayed on a screen. In the control group, the score will not be displayed. The investigators will compare the overall amount of pain in both groups, and will look at their pain management (painkillers prescribed). The investigators will also ask patients and staff for their opinions on the display.
The study will include adult patients in the emergency department at Leicester Royal Infirmary with an initial pain score of 5 or more who are able to make a decision about whether to participate. Participants will also need to be likely to stay in the hospital for more than 2 hours to allow the investigators to gather enough useful data. The study will recruit 200 participants. If the study can demonstrate that the monitor is acceptable to patients and staff and results in improved pain management, it is a low cost intervention which could be widely implemented within the NHS. It also has the potential for being used in other areas such as surgical wards. The investigators have previously found that 300-400 patients per week in the department have moderate to severe pain and might therefore benefit from this monitor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult (18 years and over)
- •underlying condition giving rise to significant pain (initial VAS pain score of 5 or more)
- •likely to be staying in the hospital for at least 2 hours
- •willing and able to give informed consent
- •able to understand and speak a good level of English
排除标准
- •children (under 18 years)
- •patients not willing to undergo routine care (analgesic treatment)
- •patients who do not have capacity to consent
- •patients who are unwilling or unable to give informed consent
- •prisoners
- •patients who cannot understand the study information in English
- •currently participating in another clinical trial as far as can be determined from information available at the time of assessment
- •patients who have a physical or visual disability which will prevent them from holding or using the pain display
结局指标
主要结局
Pain reported by the patient:11 point numerical pain scale
时间窗: Up to 6 hours
Data collected from the display using the 11 point numerical pain scale. The area under the curve will be compared between the intervention and control groups. The Numerical Rating Scale is a scale from 0-10 (whole numbers only, where 0 represents 'no pain' and 10 represents 'worst pain ever').
次要结局
- Understanding the pattern of pain (shape of the curve of pain scores) over the time of the ED stay(Up to 6 hours)
- Proportion of possible scores recorded by patients(Up to 6 hours)
- Use of analgesia in intervention and control groups (dose, time prescribed, time administered and name)(Up to 6 hours)
- Opinion of staff (including their opinion of whether patients press the button for reasons other than pain)(Up to 6 hours)
- Opinion of researchers regarding any likely stratification needs(Up to 6 hours)
- Recording time to second dose of analgesia and whether there is a pattern to this(Up to 6 hours)
- Opinion of patients(Up to 6 hours)
- Comparison of pain recorded on the display (closest minute) with verbal pain assessment at 2 and 4 hours(Up to 6 hours)