Evaluation of Efficacy and Safety of Subcutaneous Acetaminophen (APAPSubQ)

• ClinicalTrials.gov Identifier: NCT03635684
• Recruitment Status: Completed
• First Posted: August 17, 2018
• Last Update Posted: June 9, 2020
• Sponsor: Saint-Joseph University
• Information provided by (Responsible Party): Joe El Khoury, Saint-Joseph University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Pain; Fever; Drug Effect; Drug Reaction	Drug: Acetaminophen	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 31 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Evaluation of Efficacy and Safety of Subcutaneous Acetaminophen in Geriatrics and Palliative Care
• Actual Study Start Date: May 17, 2018
• Actual Primary Completion Date: June 1, 2020
• Actual Study Completion Date: June 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Change in Numerical Rating Scale pain scores for conscious and cooperative patients [ Time Frame: 60 minutes ]

   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.

2. Change on Algoplus Pain Scale for patients with verbal communication difficulties [ Time Frame: 60 minutes ]

   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.

3. Change in temperature measurement [ Time Frame: 60 minutes ]
   Decrease in temperature measurement. A Minimal Clinically Important Difference (MCID) of 0.5 degrees Celsius is set to define efficacy.
4. Appearance of local side effects [ Time Frame: at the time of perfusion, after 30 minutes, 60 minutes and 180 minutes, and one day after line removal ]

   Any local side effect is reported, including:

   • edema,
   • induration,
   • erythema,
   • tenderness,
   • warmth,
   • abcess,
   • necrosis

Secondary Outcome Measures :

1. Early effect on pain in conscious and cooperative patients [ Time Frame: 30 minutes ]
   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.
2. Sustained effect on pain in conscious and cooperative patients [ Time Frame: 180 minutes ]
   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.
3. Early effect on pain in patients with verbal communication difficulties [ Time Frame: 30 minutes ]

   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.

4. Sustained effect on pain in patients with verbal communication difficulties [ Time Frame: 180 minutes ]

   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.

5. Early effect on fever [ Time Frame: 30 minutes ]
   To evaluate if any early effect on fever is measurable, temperature is measured at t30 minutes.
6. Sustained effect on fever [ Time Frame: 180 minutes ]
   To evaluate if the effect on fever is sustained over time, temperature is measured at t180 minutes

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Lebanon

Hotel-Dieu de France

Beirut, Lebanon

Sponsors and Collaborators

Saint-Joseph University

Investigators

• Principal Investigator: Joe El Khoury, MD; Hotel-Dieu de France

More Information

• Responsible Party: Joe El Khoury, Principal Investigator, Saint-Joseph University
• ClinicalTrials.gov Identifier: NCT03635684
• Other Study ID Numbers: APAPSC2018
• First Posted: August 17, 2018
• Last Update Posted: June 9, 2020
• Last Verified: June 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Joe El Khoury, Saint-Joseph University:

Acetaminophen; Palliative Care; Infusions, Subcutaneous; Treatment Outcome; Geriatrics; Gerontology

Additional relevant MeSH terms:

Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Acetaminophen; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Antipyretics