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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03635684
Other study ID # APAPSC2018
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date May 17, 2018
Est. completion date June 1, 2020

Study information

Verified date June 2020
Source Saint-Joseph University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Acetaminophen
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.

Locations

Country Name City State
Lebanon Hotel-Dieu de France Beirut

Sponsors (1)

Lead Sponsor Collaborator
Saint-Joseph University

Country where clinical trial is conducted

Lebanon, 

Outcome

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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