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RECRUITING
NCT05825560
PHASE4

Opioid-free Analgesia in Intensive Care Unit

Sponsor: Centre Hospitalier Universitaire de Nīmes

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2023-05-15

Completion Date

2026-08-15

Last Updated

2025-05-28

Healthy Volunteers

No

Conditions

Interventions

DRUG

OFA multimodal analgesia

Multimodal opioid free analgesia

DRUG

Standard multimodal analgesia

Standard remifentanil analgesia

Locations (1)

Remy WIDEHEM

Nîmes, Gard, France