Opioid-free Analgesia in Intensive Care Unit
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 im
| Condition(s) | Intubation |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| 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 me |
| Who can participate | 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 : pa |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Centre Hospitalier Universitaire de Nīmes |
| Locations | Nîmes, Gard, France |
| Start date | 2023-05-15 |
| NCT ID | NCT05825560 |
| Official listing | https://clinicaltrials.gov/study/NCT05825560 |