Evaluation of Efficacy and Safety of Subcutaneous Acetaminophen (APAPSubQ)

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Fever; Drug Effect; Drug Reaction
• Intervention / Treatment: Drug: Acetaminophen

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 2

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • Hotel-Dieu de France

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SC Acetaminophen; Palliative Care or Geriatric Patients who receive subcutaneous Acetaminophen for pain or fever relief	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.; Other Names: Perfalgan; Paracetamol Macopharma

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Saint-Joseph University
• Investigators: Principal Investigator: Joe El Khoury, MD, Hotel-Dieu de France

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 17, 2018
• Primary Completion (ACTUAL): June 1, 2020
• Study Completion (ACTUAL): June 1, 2020

Study Registration Dates

• First Submitted: May 18, 2018
• First Submitted That Met QC Criteria: August 15, 2018
• First Posted (ACTUAL): August 17, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 6, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Palliative Care; Geriatrics; Acetaminophen; Treatment Outcome; Gerontology; Infusions, Subcutaneous
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: APAPSC2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No