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Evaluation of Efficacy and Safety of Subcutaneous Acetaminophen (APAPSubQ)

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ClinicalTrials.gov Identifier: NCT03635684
Recruitment Status : Recruiting
First Posted : August 17, 2018
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Joe El Khoury, Saint-Joseph University

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03635684


Contacts
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Contact: Joe El Khoury, MD +96170216992 joe.khoury2@net.usj.edu.lb

Locations
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Lebanon
Hotel-Dieu de France Recruiting
Beirut, Lebanon
Contact: Joe El Khoury, MD    +96170216992    joe.khoury2@net.usj.edu.lb   
Principal Investigator: Joe El Khoury, MD         
Sponsors and Collaborators
Saint-Joseph University
Investigators
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Principal Investigator: Joe El Khoury, MD Hotel-Dieu de France

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Responsible Party: Joe El Khoury, Principal Investigator, Saint-Joseph University
ClinicalTrials.gov Identifier: NCT03635684     History of Changes
Other Study ID Numbers: APAPSC2018
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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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