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Completed

NCT Number: NCT03635684

Evaluation of Efficacy and Safety of Subcutaneous Acetaminophen

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.

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Key information

Conditions

Pain Body Temperature Changes Chemically-Induced Disorders Drug Effect Drug Reaction Drug-Related Side Effects and Adverse Reactions Fever Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hotel-Dieu de France

Beirut, Lebanon

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetaminophen

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Saint-Joseph University

Other

Registry information

Official study title

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

Acronym: APAPSubQ

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 17, 2018
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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