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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
31
Subcutaneous infusion of Acetaminophen over 20 to 30 minutes, with evaluation of: * local side effects; * pain and/or fever; at time of infusion, after 30 minutes, 60 minutes and 180 minutes.
Hotel-Dieu de France
Beirut, Lebanon
Change in Numerical Rating Scale pain scores for conscious and cooperative patients
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.
Time frame: 60 minutes
Change on Algoplus Pain Scale for patients with verbal communication difficulties
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.
Time frame: 60 minutes
Change in temperature measurement
Decrease in temperature measurement. A Minimal Clinically Important Difference (MCID) of 0.5 degrees Celsius is set to define efficacy.
Time frame: 60 minutes
Appearance of local side effects
Any local side effect is reported, including: * edema, * induration, * erythema, * tenderness, * warmth, * abcess, * necrosis
Time frame: at the time of perfusion, after 30 minutes, 60 minutes and 180 minutes, and one day after line removal
Early effect on pain in conscious and cooperative patients
To evaluate if any early effect on pain is measurable, this outcome measures the pain scores at t30 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.
Time frame: 30 minutes
Sustained effect on pain in conscious and cooperative patients
To evaluate if the effect on pain is sustained over time, this outcome measures the pain scores at t180 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.
Time frame: 180 minutes
Early effect on pain in patients with verbal communication difficulties
To evaluate if any early effect on pain is measurable, this outcome measures the pain scores at t60 minutes and t180 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.
Time frame: 30 minutes
Sustained effect on pain in patients with verbal communication difficulties
To evaluate if the effect on pain is sustained over time, this outcome measures the pain scores at t180 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.
Time frame: 180 minutes
Early effect on fever
To evaluate if any early effect on fever is measurable, temperature is measured at t30 minutes.
Time frame: 30 minutes
Sustained effect on fever
To evaluate if the effect on fever is sustained over time, temperature is measured at t180 minutes
Time frame: 180 minutes
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