Evaluation of Efficacy and Safety of Subcutaneous Acetaminophen

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of Efficacy and Safety of Subcutaneous Acetaminophen in Geriatrics and Palliative Care

Conditions
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Pain, Fever, Drug Effect, Drug Reaction

Intervention / Treatment
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* Drug: Acetaminophen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SC Acetaminophen<br>Palliative Care or Geriatric Patients who receive subcutaneous Acetaminophen for pain or fever relief | Drug: Acetaminophen<br>* 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.<br>* Other names: Paracetamol Macopharma;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 60 minutes | 
| Appearance of local side effects | Any local side effect is reported, including: edema, induration, erythema, tenderness, warmth, abcess, necrosis | at the time of perfusion, after 30 minutes, 60 minutes and 180 minutes, and one day after line removal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 180 minutes | 
| Early effect on fever | To evaluate if any early effect on fever is measurable, temperature is measured at t30 minutes. | 30 minutes | 
| Sustained effect on fever | To evaluate if the effect on fever is sustained over time, temperature is measured at t180 minutes | 180 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acetaminophen, Palliative Care, Infusions, Subcutaneous, Treatment Outcome, Geriatrics, Gerontology