Clinical trial NCT03635684: Evaluation of Efficacy and Safety of Subcutaneous Acetaminophen
Official title: Evaluation of Efficacy and Safety of Subcutaneous Acetaminophen in Geriatrics and Palliative Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Fever
Drug Effect
Drug Reaction
Keywords: Acetaminophen
Palliative Care
Infusions, Subcutaneous
Treatment Outcome
Geriatrics
Gerontology
Lead sponsor: Saint-Joseph University
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Numerical Rating Scale pain scores for conscious and cooperative patients
timeFrame: 60 minutes
measure: Change on Algoplus Pain Scale for patients with verbal communication difficulties
timeFrame: 60 minutes
measure: Change in temperature measurement
timeFrame: 60 minutes
measure: Appearance of local side effects
timeFrame: at the time of perfusion, after 30 minutes, 60 minutes and 180 minutes, and one day after line removal
Secondary outcomes:
measure: Early effect on pain in conscious and cooperative patients
timeFrame: 30 minutes
measure: Sustained effect on pain in conscious and cooperative patients
timeFrame: 180 minutes
measure: Early effect on pain in patients with verbal communication difficulties
timeFrame: 30 minutes
measure: Sustained effect on pain in patients with verbal communication difficulties
timeFrame: 180 minutes
measure: Early effect on fever
timeFrame: 30 minutes
measure: Sustained effect on fever
timeFrame: 180 minutes
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Hotel-Dieu de France
Study officials:
affiliation: Hotel-Dieu de France
name: Joe El Khoury, MD
role: PRINCIPAL_INVESTIGATOR
References: