RecruitingPhase 4NCT05825560

Opioid-free Analgesia in Intensive Care Unit

Opioid-free Analgesia in Intensive Care Unit: a Prospective, Monocentric, Randomized, Double Blind, Feasability Clinical Trial

Sponsor

Centre Hospitalier Universitaire de Nīmes

Enrollment

50 participants

Start Date

May 15, 2023

Study Type

INTERVENTIONAL

Conditions

Intubation

Summary

ICU patients experience moderate to severe pain. Studies and guidelines point out the benefits of multimodal analgesia on pain control, opioid spare and on lowering its adverse effects. However, no recommendation about drugs or protocol has been formulated. In our study, investigators studied the feasibility and the impact on Remifentanil spare of a standardized protocol using multimodal analgesia (Paracetamol, Nefopam, Tramadol, Ketamine, Remifentanil) compared to the standard-of-care strategy using Paracetamol and Remifentanil. The investigators conducted a prospective, ''proof of concept'', randomized, double-blind, parallel group, placebo-controlled trial. The investigators studied multimodal analgesia versus standard-of-care in ICU patients requiring sedation-analgesia for invasive mechanical ventilation.The investigators hypothesized that Remifentanil consumption decrease by 15% with the use of a standardized multimodal analgesia strategy

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether an opioid-free pain management protocol works as well as standard opioid-based pain control for patients in the ICU who require mechanical ventilation. Opioids are commonly used in ICU sedation-analgesia regimens, but they carry risks including respiratory depression, dependency, gut dysfunction, immune suppression, and prolonged ICU stays. An opioid-free approach using combinations of other pain and sedation medications could provide effective comfort while avoiding these downsides. Adults aged 18 and older who are admitted to a French ICU, require mechanical ventilation for more than 2 but less than 24 hours initially, and have appropriate consent are eligible. People with allergies to any of the study drugs (paracetamol, nefopam, tramadol, ketamine, remifentanil), severe liver insufficiency, severe ARDS, those who are pregnant or breastfeeding, or those requiring muscle relaxants are not eligible. Participants will be randomly assigned to either the opioid-free protocol or standard care and assessed for pain control, time on ventilation, ICU length of stay, and complications. This research is important because opioid use in the ICU is pervasive and contributes to long-term harm including post-ICU opioid use and prolonged recovery. If opioid-free protocols can deliver equivalent or better comfort, they could transform how critically ill patients are managed.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.