RecruitingPHASE4INTERVENTIONAL

Opioid-free Analgesia in Intensive Care Unit

This study, called 'Opioid-free Analgesia in Intensive Care Unit', is for patients in intensive care who need help breathing with a machine. Many of these patients experience significant pain. Doctors are comparing two ways to give pain relief: a standard method using common pain medications and a new method that uses a combination of several different pain medications. The main goal is to see if this new, combined approach can effectively relieve pain while reducing the amount of strong opioid painkillers, like Remifentanil, that patients need. Reducing opioids can help avoid their side effects. The study aims to find the best way to manage pain for these very ill patients.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Centre Hospitalier Universitaire de Nīmes

Enrolment target

Start

15 May 2023

Estimated completion

15 Aug 2026

Intubation

What is this study about?

When patients are very unwell and need to be in intensive care, they often require help from a breathing machine. This can be an uncomfortable experience, and it's common for these patients to feel a lot of pain. Doctors and nurses work hard to keep patients comfortable, and they often use strong painkillers.

This study is looking into the best ways to manage this pain. Currently, there isn't one perfect recommendation for which pain medications to use or how to use them. This particular study is comparing two ways to treat pain in patients on breathing machines. One is the 'standard care' method, which typically involves paracetamol and a strong opioid called Remifentanil.

The other method is a newer, 'multimodal' approach. This means using a combination of different pain medications working together, including paracetamol, nefopam, tramadol, and ketamine, along with Remifentanil if needed. The main idea behind this new approach is that by combining different pain relievers, patients might feel less pain and need less of the strong opioid medication, Remifentanil. Reducing the amount of opioids can be beneficial as these drugs can have side effects.

The study researchers want to see if this new combined pain relief strategy is practical and if it truly helps reduce the amount of Remifentanil needed. They believe it could lead to patients needing about 15% less Remifentanil. Finding better ways to manage pain and reduce opioid use is important for improving how patients recover in intensive care.

Key takeaways

This study compares two ways to manage pain for patients on breathing machines in intensive care.
It aims to see if a combination of pain medications can reduce the need for strong opioid painkillers.
Patients are randomly assigned to either the standard pain relief or the new combined approach.
Your comfort and pain relief will be closely monitored throughout the study.
The study lasts for at least 72 hours while you are on the breathing machine.

Who may be eligible?

To join this study, you need to be an adult over 18 years old who is currently in intensive care. You must need a breathing machine for at least two hours but not more than 24 hours at the time you might join. Also, it's important that you are expected to need the breathing machine for at least 48 hours.

There are several reasons why someone might not be able to join. For example, if you're already in another study that might affect the pain relief results, or if you have severe liver problems. You also can't join if you have any allergies or known reasons why you shouldn't take any of the pain medications being used in the study, such as paracetamol, nefopam, tramadol, ketamine, or remifentanil. Pregnant or breastfeeding individuals, and those with certain severe breathing difficulties (known as ARDS) or who need specific muscle-relaxing drugs, would also not be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you in intensive care and need a breathing machine?
Have you been on the breathing machine for less than 24 hours?
Are you expected to need the breathing machine for at least 48 hours?
Do you have any allergies to paracetamol, nefopam, tramadol, ketamine, or remifentanil?
Do you have severe liver problems or certain severe breathing conditions?

Answer every question to see your result.

What does participation involve?

If you or your legal representative agree to take part, you would be assigned by chance to one of two groups. One group would receive the standard pain relief package, which includes paracetamol and Remifentanil. The other group would receive the new combined pain relief package, which includes paracetamol, nefopam, tramadol, ketamine, and Remifentanil if needed, given at different levels depending on your pain.

Neither you, your family, nor the doctors and nurses looking after you would know which group you are in for the first 72 hours. This is done to make sure the study results are fair. Your pain levels and comfort would be regularly checked. Sedation medications (to help you relax) would be given as usual to keep you comfortable. The study aims to follow you for at least 72 hours while you are on the breathing machine to see how the pain relief is working.

Potential risks and benefits

The main benefit of taking part could be receiving a pain relief strategy that potentially reduces the need for strong opioid medications, which might lessen their side effects. However, there's always a chance that the new treatment might not work as well for you, or you could experience side effects from the study medications, though these will be closely monitored. As with all clinical trials, you are free to withdraw from the study at any time without giving a reason, and your medical care will not be affected.

Locations (1)

Remy WIDEHEM
Verified postcode
Nîmes, France· Recruiting

Common questions

What is 'multimodal analgesia'?

It's a way of treating pain by using a combination of different pain medications instead of just one or two, hoping they work better together.

What is Remifentanil?

Remifentanil is a strong painkiller that belongs to the opioid family, often used in intensive care patients.

Why is reducing opioids important?

Reducing opioids can help lower the risk of side effects like constipation, nausea, breathing problems, and can make it easier to recover.

Will I know which treatment I'm getting?

No, for the first 72 hours, neither you, your family, nor your healthcare team will know if you're getting the standard or the new combined pain relief. This is to ensure the study is fair.

What does 'intubation' mean?

Intubation means having a tube placed into your windpipe to help you breathe, usually connected to a breathing machine.

How to find out more

Remy WIDEHEM, Dr.

remy.widehem@chu-nimes.fr +33 4.66 68 30 50 Official trial record

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