Adjuvant Analgesic Use in the Critically Ill: A Systematic Review and Meta-Analysis.
Kathleen E Wheeler, Ryan Grilli, John E Centofanti...
https://pubmed.ncbi.nlm.nih.gov/32696016Actively Recruiting
Phase 4
Age: 18Years +
All Genders
ID05825560
Opioid-free Analgesia in Intensive Care Unit: a Prospective, Monocentric, Randomized, Double Blind, Feasability Clinical Trial
Led by Centre Hospitalier Universitaire de Nīmes · Updated on 2025-05-28
50
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating pain management strategies for ICU patients who require sedation and mechanical ventilation. The study aims to compare a multimodal analgesia approach, which uses several drugs together, to the current standard method that mainly uses Paracetamol and Remifentanil. This randomized, double-blind trial investigates whether the multimodal strategy can reduce the consumption of Remifentanil by 15%, potentially minimizing opioid use and its related side effects. Participants are randomly assigned to one of two groups. The control group receives standard analgesia with Paracetamol and Remifentanil adjusted based on pain level measured by the Behavior Pain Scale (BPS). The experimental group receives a stepped multimodal analgesia protocol including Paracetamol, Nefopam, Tramadol, and Ketamine, with Remifentanil added only if necessary. Pain and sedation levels are regularly assessed to adjust medication doses over a 72-hour blinded treatment period. During the study, patients' pain levels are monitored frequently, with medication doses adjusted accordingly. Researchers measure daily Remifentanil consumption at 48 hours as the primary outcome. Additional assessments include morphine use, sedative consumption, ventilation duration, organ function, and potential side effects up to 90 days. The study tracks patients through the initial ICU treatment period and follows key health outcomes to evaluate the impact of the analgesia methods.
CONDITIONS
Brief Title
Opioid-free Analgesia in Intensive Care Unit
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patient hospitalized in ICU and requiring sedation-analgesia for mechanical ventilation
- Mechanical ventilation duration between more than 2 hours and less than 24 hours
- Signed informed consent by patient or authorized representative
- Affiliated to the French Government Public Health Insurance
- Patient age 18 years or older
You will not qualify if you...
- Participation in another trial affecting the primary outcome
- Within exclusion period of another trial
- Expected mechanical ventilation less than 48 hours
- Allergies or contraindications to paracetamol, nefopam, tramadol, ketamine, or remifentanil
- Hepatic insufficiency with prothrombin time less than 50%
- Pregnant or breastfeeding patient
- Moderate to severe Acute Respiratory Distress Syndrome with PaO2/FiO2 ratio under 150mmHg after optimization
- Requirement for curare treatment
- Indication for locoregional analgesia before extubation (e.g., epidural)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - At least 48 hours of mechanical ventilation with sedation-analgesia
Participants receive either standard opioid analgesia or a multimodal opioid-free analgesia regimen while mechanically ventilated in the ICU. Analgesia is adjusted based on pain assessments and sedation targets during mechanical ventilation.
Continuous monitoring and reassessment every 30 minutes initially, then every 2 hours during treatment
Follow-up
Duration - Up to 90 days after treatment
Participants are monitored for outcomes such as sedative consumption, duration of mechanical ventilation, organ function, adverse events, and recovery up to 90 days after treatment.
Periodic assessments up to Day 90, including visits at Day 28 and Day 90
Trial Site Locations
Total: 1 location
1
Remy WIDEHEM
Nîmes, Gard, France, 30029
Actively Recruiting
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Research Team
R
Remy WIDEHEM, Dr.
C
Claire ROGER, Dr. PhD
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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Published Research Related To This Trial
Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU.
John W Devlin, Yoanna Skrobik, Céline Gélinas...
https://pubmed.ncbi.nlm.nih.gov/30113379Effect of a multimodal analgesia strategy on remifentanil daily consumption in mechanically ventilated adult ICU patients: study protocol for a randomised, placebo-controlled, double-blind, parallel-group clinical trial.
Remy Widehem, Camille Nicolet, Violaine Delannoy...
https://pubmed.ncbi.nlm.nih.gov/39832962