Evaluation of Efficacy and Safety of Subcutaneous Acetaminophen

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Saint-Joseph University

TEST CLINICO: NCT03635684

BioSeek: nct03635684

Parole chiave

Astratto

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.

Descrizione

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.

Date

Ultimo verificato:	05/31/2020
Primo inviato:	05/17/2018
Iscrizione stimata inviata:	08/14/2018
Primo pubblicato:	08/16/2018
Ultimo aggiornamento inviato:	06/05/2020
Ultimo aggiornamento pubblicato:	06/08/2020
Data di inizio effettiva dello studio:	05/16/2018
Data di completamento primaria stimata:	05/31/2020
Data stimata di completamento dello studio:	05/31/2020

Condizione o malattia

Pain

Fever

Drug Effect

Drug Reaction

Intervento / trattamento

Drug: SC Acetaminophen

Fase

Fase 2

Gruppi di braccia

Braccio	Intervento / trattamento
Experimental: SC Acetaminophen Palliative Care or Geriatric Patients who receive subcutaneous Acetaminophen for pain or fever relief	Drug: SC 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.

Criteri di idoneità

Età idonea per lo studio	18 Years Per 18 Years
Sessi idonei allo studio	All
Accetta volontari sani	sì
Criteri	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

Risultato

Misure di esito primarie

1. Change in Numerical Rating Scale pain scores for conscious and cooperative patients [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 [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 [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 [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

Misure di esito secondarie

1. Early effect on pain in conscious and cooperative patients [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 [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 [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 [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 [30 minutes]

To evaluate if any early effect on fever is measurable, temperature is measured at t30 minutes.

6. Sustained effect on fever [180 minutes]

To evaluate if the effect on fever is sustained over time, temperature is measured at t180 minutes