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Could a cocktail of Non-Opioid drugs replace Morphine-Like painkillers in the ICU?

NCT ID NCT05825560

Symptom relief Sponsor: Centre Hospitalier Universitaire de Nīmes Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This trial investigates whether a combination of non-opioid pain medications (paracetamol, nefopam, tramadol, and ketamine) can effectively manage pain in intensive care unit patients who need a breathing machine, while reducing the use of the opioid remifentanil. The study involves 50 adults in the ICU who have been on a ventilator for 2 to 24 hours. Half receive the standard opioid-based pain regimen, and the other half receive the opioid-free mix, with neither patients nor doctors knowing which group they are in. The main goal is to see if the opioid-free approach cuts remifentanil use by at least 15% in the first 48 hours.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Multimodal opioid-free analgesia (paracetamol, nefopam, tramadol, ketamine)
What this could lead to
If successful, this approach could reduce reliance on opioids for ICU patients, lowering risks like addiction and breathing problems.
What could go wrong
This is a small, early feasibility study with only 50 participants, so results may not apply broadly. The drug combination may not work as well as opioids for pain control.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

50 people

The number who actually took part.

Started

May 2023

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient hospitalized in ICU and requiring sedation-analgesia for mechanical ventilation. * Patient undergoing mechanical ventilation for more than 2 hours and less than 24 hours. * Informed consent signed by the patient or his trusted person, legal representative, family member, curator or tutor, or emergency consent procedure. * Patient affiliated to the French Government Public Health Insurance. * Patient over 18 years old. Exclusion Criteria: * Patient already involved in a trial that might influence our primary endpoint. * Patient in exclusion-period determined by another trial or study. * Patient who is likely to be requiring less than 48 hours of mechanical ventilation. * Patient with contraindication or allergies to at least one of the following medication : paracetamol, nefopam, tramadol, ketamine, remifentanil. * Patient with hepatic insufficiency (defined as PT \< 50%). * Parturient or breast-feeding patient. * Patient suffering from moderate to severe Acute Respiratory Distress Syndrome (ARDS), with decreased PaO2/FiO2 ratio under 150mmHg after respiratory optimization (courant volume 6mL/kg and PEEP \> 5mbar). * Patient requiring curare treatment. * Patients with an indication for locoregional analgesia prior to extubation (perineural sealing, epidural analgesia).

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intubation

Contacts and locations

Locations

  • Remy WIDEHEM

    Nîmes, Gard, 30029, France

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