AuthorisedPhase II and Phase III (Integrated)Interventional

Pilot study of the pharmacokinetic profile of paracetamol subcutaneously versus intravenously in patients in a palliative situation

This study is investigating paracetamol, a common painkiller, in people who are receiving palliative care. Researchers want to compare two ways of giving the medicine: directly into a vein, which is common, and a newer method where it's given just under the skin. The main goal is to understand how the body processes paracetamol differently with each method and to see if the under-the-skin method works as well for pain relief. They will also be checking for any side effects and how comfortable patients are with each method. This could lead to more convenient ways to manage pain for people in palliative care.

At a glance

Status

Authorised

Phase

Phase II and Phase III (Integrated)

Sponsor

Centre Hospitalier Universitaire De Caen Normandie

Enrolment target

Start

28 Oct 2024

Adult patients (> 18 years of age) undergoing palliative care (defined by the WHO as active comprehensive care given to patients whose condition does not respond to curative treatment) of their disease able to communicate and with a functional central venous line with reflux presenting spontaneous pain with a numerical scale greater than 3 or paracetamol as part of their usual treatment.

What is this study about?

This study is focusing on paracetamol, a widely used pain relief medicine, for adults receiving palliative care. Palliative care is special support and treatment for people with serious illnesses that don't respond to curative treatments. The aim is to improve their quality of life, often by managing symptoms like pain.

The main purpose of this study is to compare two ways of giving paracetamol: directly into a vein (intravenously), which is a common approach, and giving it just under the skin (subcutaneously). The researchers want to understand how the body takes in, uses, and gets rid of paracetamol differently depending on how it's given. They'll be measuring levels of paracetamol in participants' blood to get a clear picture of this process.

Beyond just tracking the medicine, the study will also look at how effective each method is at reducing pain, how well patients tolerate the treatment, and if there are any side effects. This research is important because finding easier or more comfortable ways to give pain medication could really help improve the care for people living with serious illnesses.

Key takeaways

Compares two ways of giving paracetamol for pain relief.
Aims to find out how paracetamol works in the body.
Focuses on adult patients receiving palliative care.
Checks for pain relief, tolerance, and side effects.
Could lead to more comfortable ways to give pain medication.

Who may be eligible?

This study is looking for adults aged 18 or older who are receiving palliative care for an illness that can't be cured. To join, you need to be able to talk and communicate clearly with the study team.

You also need to have a special tube called a central venous line already in place, which allows for medicines to be given directly into your bloodstream. You would be a good fit if you currently experience pain that scores more than 3 on a pain scale (where 10 is the worst pain), or if paracetamol is already part of your usual treatment for pain.

Both men and women can take part in this study.

Quick self-check

Are you 18 years old or older?
Are you currently receiving palliative care?
Can you communicate clearly?
Do you have a central venous line already in place?
Do you have pain scoring more than 3, or is paracetamol part of your current treatment?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you will receive paracetamol in two different ways – once directly into a vein through your central line, and once just under your skin. The order of these might be different for each person. Throughout the study, you will have regular blood tests to check the levels of paracetamol in your body.

The study team will also regularly ask you about your pain levels using a simple scale. They will check the area where the medicine is given, especially for the under-the-skin method, to make sure there are no issues. Any side effects or problems you experience will be carefully recorded. The total time you would be involved in the study, including follow-up, would be about 30 days.

Potential risks and benefits

A potential benefit of taking part is that you might help researchers discover new and potentially more comfortable ways to manage pain for people in palliative care. There is always a risk with any medical treatment; in this study, potential risks could include discomfort or a reaction where the injection is given, or other side effects from paracetamol itself, which will be carefully monitored. Remember, participating is entirely your choice, and you are free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

—
France

Common questions

What is palliative care?

Palliative care helps people with serious illnesses live as well as possible by focusing on comfort and quality of life, rather than trying to cure the illness.

What does 'subcutaneously' mean?

It means giving medicine by injecting it just under the skin, usually with a small needle.

What does a 'central venous line' do?

It's a small, flexible tube placed into a large vein to give medicines, fluids, or nutrition directly into the bloodstream.

Will I stop my other pain medication?

The study looks at paracetamol as part of your usual treatment. Any changes to your other medications would be discussed with your doctor.

How long will I be in the study?

Your participation, including follow-up checks, will last for about 30 days.

How to find out more

Official trial record

Always speak to your GP or specialist before deciding to take part in a study.