Evaluation of Efficacy and Safety of Subcutaneous Acetaminophen

NCT ID: NCT03635684

Last Updated: 2020-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-17
• Study Completion Date: 2020-06-01

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.

Conditions

Pain; Fever; Drug Effect; Drug Reaction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

SC Acetaminophen

Palliative Care or Geriatric Patients who receive subcutaneous Acetaminophen for pain or fever relief

Group Type: EXPERIMENTAL

Acetaminophen

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Perfalgan; Paracetamol Macopharma

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saint-Joseph University

OTHER

Sponsor Role: lead

Responsible Party

Joe El Khoury

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joe El Khoury, MD

Role: PRINCIPAL_INVESTIGATOR

Hotel-Dieu de France

Locations

Hotel-Dieu de France

Beirut, , Lebanon

Countries

Lebanon

Other Identifiers

APAPSC2018

Identifier Type: -

Identifier Source: org_study_id