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Study on Opioid-Free Pain Relief for ICU Patients on Ventilators Using Nefopam Hydrochloride, Paracetamol, and Ketamine Hydrochloride

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on patients in the Intensive Care Unit (ICU) who require mechanical ventilation, which is a machine that helps them breathe. The study is exploring a new approach to pain management that does not rely on major opioids, which are strong pain-relieving drugs. Instead, the trial will use a combination of different medications to manage pain. The medications being studied include nefopam hydrochloride, sodium chloride, remifentanil hydrochloride, paracetamol, ketamine hydrochloride, and tramadol hydrochloride. These medications are administered through intravenous use, meaning they are given directly into a vein.

The purpose of the study is to compare the amount of remifentanil used between two groups of ICU patients. One group will follow a standard pain management strategy without major opioids, while the other group will follow the conventional strategy that includes opioids. The trial will observe patients from the 24th hour to the 48th hour after they are randomly assigned to one of the two groups. The study will last up to 28 days for each patient, and it aims to see if the new approach can effectively manage pain while reducing the use of opioids.

Throughout the study, researchers will monitor various aspects of the patients' health, such as the total amount of remifentanil used, the number of days patients are free from this medication, and the number of days they are free from mechanical ventilation. Other factors being observed include the presence of any side effects like constipation or nausea, the occurrence of pneumonia related to mechanical ventilation, and the length of stay in the ICU and hospital. The study will also track the patients' overall health status at 28 and 90 days after the trial begins.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, you will be informed about the study's purpose and procedures. You will need to provide informed consent, which means you agree to participate after understanding the trial details.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes checking if you are over 18 years old, have been on mechanical ventilation for more than 2 hours but less than 24 hours, and are affiliated with the French Government Public Health Insurance.

  3. Step 3

    Randomization

    You will be randomly assigned to one of two groups: one following a standardized multimodal analgesia strategy without major opioids, and the other following the conventional strategy.

  4. Step 4

    Treatment administration

    You will receive medications through intravenous use. The medications include nefopam hydrochloride, sodium chloride, remifentanil hydrochloride, paracetamol, ketamine hydrochloride, and tramadol hydrochloride. The specific dosage and frequency will be determined by the medical team based on your needs.

  5. Step 5

    Monitoring and assessments

    Throughout the trial, your health and response to the treatment will be closely monitored. This includes daily assessments of your medication consumption, the number of days free from certain medications, and your overall health status using various tests and scores.

  6. Step 6

    End of trial participation

    Your participation in the trial will continue until the study's end date or until you no longer meet the criteria for participation. The estimated end date for the trial is December 31, 2026.

Who can join the trial?

5 criteria

  • Patient is in the ICU (Intensive Care Unit) and needs **sedation-analgesia** (medication to keep you calm and pain-free) for **mechanical ventilation** (a machine that helps you breathe).
  • Patient has been on **mechanical ventilation** for more than 2 hours but less than 24 hours.
  • **Informed consent** is signed by the patient or a trusted person, legal representative, family member, curator, or tutor, or through an emergency consent procedure. This means someone has agreed to the patient's participation in the study.
  • Patient is affiliated with the French Government Public Health Insurance.
  • Patient is over 18 years old.

Who cannot join the trial?

3 criteria

  • Patients who are not currently on a breathing machine (also known as mechanical ventilation) for at least 72 hours cannot participate.
  • Patients who are not between the ages of 18 and 65 cannot participate.
  • Patients who are part of a vulnerable population, such as those who cannot give consent or are in a dependent relationship, cannot participate.
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Investigated drugs

Remifentanil is a medication used to relieve pain. It is a type of opioid, which means it works by blocking pain signals in the brain. In this clinical trial, remifentanil is used to compare its consumption between two groups of patients in the intensive care unit who need mechanical ventilation for at least 72 hours. The trial aims to see how much remifentanil is needed when patients follow a standard pain management plan without using major opioids, compared to a conventional pain management plan.

What is already known about the treatment

Remifentanil – Remifentanil is administered intravenously, meaning it is given directly into a vein through an injection or infusion. It is currently used in medical settings, particularly in intensive care units, to manage pain and sedation during procedures like intubation. The main therapeutic indication for remifentanil is to provide pain relief and sedation for patients who require mechanical ventilation. At the molecular level, remifentanil works by binding to opioid receptors in the brain, which helps to block pain signals and produce a calming effect. It is classified pharmacologically as an opioid analgesic, but in this trial, it is being compared to a strategy that minimizes the use of major opioids.

Investigated diseases

Intubation – Intubation is a medical procedure where a tube is inserted into the trachea through the mouth or nose to maintain an open airway. This is often necessary for patients who cannot breathe on their own, such as those under anesthesia or in critical care. The process involves passing the tube through the vocal cords and into the trachea, ensuring that air can reach the lungs. Over time, if the tube remains in place, it can lead to complications such as infection or damage to the trachea. The progression of intubation-related issues can include difficulty in speaking or swallowing and potential airway obstruction. Regular monitoring and care are essential to manage these risks and ensure the tube functions correctly.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517770-14-00Protocol codeLOCAL/2022/RW-01Estimated enrolment50 patientsSponsorCentre Hospitalier Universitaire De Nimes

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