NCT03635684

Evaluation of Efficacy and Safety of Subcutaneous Acetaminophen

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Saint-Joseph University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-05-17
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2018-08-17
• Last updated: 2020-06-09

Locations

1 site across 1 country: Lebanon