drugset / Trial / NCT05825560

Opioid-free Analgesia in Intensive Care Unit

NCT05825560

Phase 4 Completed 50 enrolled Nîmes University Hospital
RandomizedParallel-groupTriple-blindTreatment

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

Timeline

Start
2023-05-15
Primary completion
2026-06-16
Completion
2026-06-16

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Ketamine Small molecule 0.15 mg/kg
Subject Nefopam Small molecule 120 mg Intravenous
Subject Remifentanil Small molecule
Subject Tramadol Other / unclassified 450 mg Intravenous
Comparator Acetaminophen Small molecule 1 g

Indications

No indication recorded.