Tolerance and Efficiency of Paracetamol Subcutaneous Injection

The purpose of this study is to evaluate the tolerance and the efficiency of subcutaneous administration of Paracetamol for patients in palliative care.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHR Metz-Thionville, Metz, France

About this study

Subcutaneous administration is the most commonly used way for palliative care and geriatric service. A lot of drugs are recommended with subcutaneous administration, but their use is performed out of the Marketing Authorization, and fewer data exist about this practice in literature. Paracetamol is a grade 1 analgesic not currently recommended for subcutaneous injection, because of the lack of validated references. However this kind of administration is usually performed for Paracetamol in the French palliative care services related with its advantages for patients, as analgesic or antipyretic. The assumption of the study is that the use of paracetamol subcutaneously is possible with a good tolerance for hospitalized patients in palliative care service.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

older than 18 years old
indication of paracetamol by subcutaneous injection, as an analgesic or an antipyretic

Exclusion criteria

opposition to gather data patient
subcutaneous administration of paracetamol during the last week before the inclusion of the patient

Treatment and study plan

Primary outcomes

Occurrence of the severe or not adverse effects on the injection site

Time frame: 8 days

Secondary outcomes

as antipyretic, a feedback of tympanic temperature below 38°C during the two hours after injection

Time frame: 8 days
as analgesic, the decrease of pain (decrease of 30 in the numerical scale score, or a Algo+ scale score lower than 2/5)

Time frame: 8 days

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional Metz-Thionville

Other

Registry information

Official study title

Tolerance and Efficiency of Paracetamol bu Subcutaneous Releasing in Patients Hospitalized Into Palliative Care

Acronym: TEPASC

Important dates

Study start: 2014
Primary completion: 2018
Study completion: 2018
First posted: Aug 31, 2016
Registry last updated: Apr 16, 2019

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.

Published trials that share one or more normalized conditions with this study.

Completed