Evaluation of Efficacy and Safety of Subcutaneous Acetaminophen in Geriatrics and Palliative Care
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Change on Algoplus Pain Scale for patients with verbal communication difficulties
研究概览
简要总结
Subcutaneous perfusion is an underused technique, the effectiveness of which has been demonstrated.
A number of drugs of different therapeutic classes, including morphine, have a good level of scientific evidence for use by this route.
Subcutaneous Acetaminophen injection is being used in some medical centers, mainly in Europe, despite the lack of definite evidence on its efficacy.
This study aims to quantify the degree of effectiveness of subcutaneous Acetaminophen infusions for pain or fever in Geriatrics and Palliative Care, as well as determining its safety.
详细描述
Subcutaneous perfusion is an underused technique, the effectiveness of which has been demonstrated. It is mainly used in Palliative Care and Geriatrics when a venous line is not available. It is a simple and comfortable technique that allows to administer solutes and / or medications continuously or discontinuously in the subcutaneous tissue.
A number of drugs of different therapeutic classes, including morphine, have a good level of scientific evidence for use by this route.
Subcutaneous Acetaminophen injection is being used in some medical centers, mainly in Europe, despite the lack of definite evidence on its efficacy. It is sometimes accused of causing pain at the injection site; it seems that this is not the case if it is infused slowly, over 20 minutes to 30 minutes. There is no report of serious local effects.
The consultation palliative care team at Hôtel-Dieu de France (HDF) has used subcutaneous Acetaminophen infusions repeatedly without adverse effects since January 2014.
This study aims to quantify the degree of effectiveness of subcutaneous Acetaminophen infusions for pain or fever in Geriatrics and Palliative Care, as well as determining its safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients seen by the Palliative Care Consultation Team, patients admitted in the Palliative Care Unit, or Geriatric patients (patients aged 65 and older) in participating centers in Lebanon
- •Presence of pain or fever necessitating the administration of Paracetamol
- •Absence of an Intravenous Line
排除标准
- 未提供
研究组 & 干预措施
SC Acetaminophen
Palliative Care or Geriatric Patients who receive subcutaneous Acetaminophen for pain or fever relief
干预措施: Acetaminophen (Drug)
结局指标
主要结局
Change on Algoplus Pain Scale for patients with verbal communication difficulties
时间窗: 60 minutes
This outcome measures the decrease in pain scores between t0 (right before acetaminophen administration) and t60 minutes using Algoplus Scale, a behavioural rating scale for acute pain for patients with verbal communication difficulties. A score of 2 or above diagnoses pain with 87% sensitivity and 80% specificity. The scale evaluates facial expressions, look, complaints, body position and atypical behaviours of patients with verbal communication difficulties. Each item marked "yes" is awarded one point and the total across all the items gives a total score out of 5. Efficacy is defined as a decrease of the score to less than 2/5.
Change in temperature measurement
时间窗: 60 minutes
Decrease in temperature measurement. A Minimal Clinically Important Difference (MCID) of 0.5 degrees Celsius is set to define efficacy.
Appearance of local side effects
时间窗: at the time of perfusion, after 30 minutes, 60 minutes and 180 minutes, and one day after line removal
Any local side effect is reported, including: * edema, * induration, * erythema, * tenderness, * warmth, * abcess, * necrosis
Change in Numerical Rating Scale pain scores for conscious and cooperative patients
时间窗: 60 minutes
This outcome measures the decrease in pain scores between t0 (right before acetaminophen administration) and t60 minutes using the Numerical Rating Scale in conscious and cooperative patients, where 10/10 is the worst imaginable pain and 0/10 is no pain at all. A Minimal Clinically Important Difference (MCID) of 2/10 is set to define efficacy.
次要结局
- Early effect on pain in patients with verbal communication difficulties(30 minutes)
- Early effect on pain in conscious and cooperative patients(30 minutes)
- Sustained effect on pain in conscious and cooperative patients(180 minutes)
- Sustained effect on pain in patients with verbal communication difficulties(180 minutes)
- Early effect on fever(30 minutes)
- Sustained effect on fever(180 minutes)
研究者
Joe El Khoury
Principal Investigator
Saint-Joseph University