Pain Clinical Trial
— APAPSubQOfficial title:
Evaluation of Efficacy and Safety of Subcutaneous Acetaminophen in Geriatrics and Palliative Care
Verified date | June 2020 |
Source | Saint-Joseph University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 31 |
Est. completion date | June 1, 2020 |
Est. primary completion date | June 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Lebanon | Hotel-Dieu de France | Beirut |
Lead Sponsor | Collaborator |
---|---|
Saint-Joseph University |
Lebanon,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Early effect on fever | To evaluate if any early effect on fever is measurable, temperature is measured at t30 minutes. | 30 minutes | |
Secondary | Sustained effect on fever | To evaluate if the effect on fever is sustained over time, temperature is measured at t180 minutes | 180 minutes |
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