Actively Recruiting
Opioid-free Analgesia in Intensive Care Unit
Led by Centre Hospitalier Universitaire de Nīmes · Updated on 2025-05-28
50
Participants Needed
1
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Opioid-free Analgesia in Intensive Care Unit
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 a 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.
You will not qualify if you...
- Patient already involved in a trial that might influence the primary endpoint.
- Patient in exclusion period determined by another trial or study.
- Patient likely to require less than 48 hours of mechanical ventilation.
- Patient with contraindications or allergies to paracetamol, nefopam, tramadol, ketamine, or remifentanil.
- Patient with hepatic insufficiency (PT < 50%).
- Pregnant or breastfeeding patient.
- Patient with moderate to severe Acute Respiratory Distress Syndrome (ARDS), with PaO2/FiO2 ratio under 150mmHg after respiratory optimization.
- Patient requiring curare treatment.
- Patient with indication for locoregional analgesia prior to extubation (perineural sealing, epidural analgesia).
AI-Screening
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Trial Site Locations
Total: 1 location
1
Remy WIDEHEM
Nîmes, Gard, France, 30029
Actively Recruiting
Research Team
R
Remy WIDEHEM, Dr.
CONTACT
C
Claire ROGER, Dr. PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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