Opioid-free pain management in ICU patients

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

This study is testing a new pain management approach for ICU patients on ventilators to see if it can reduce the need for a strong pain medication while still keeping pain under control.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Universitaire de Nīmes (Academic / other)
• Locations: 1 site (Nîmes, Gard)
• Trial ID: NCT05825560 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of a standardized multimodal analgesia protocol in ICU patients requiring sedation for mechanical ventilation. Participants are randomized into two groups: one receiving standard care with Paracetamol and Remifentanil, and the other receiving a combination of Paracetamol, Nefopam, Tramadol, Ketamine, and Remifentanil based on pain assessment. The goal is to determine if this approach can reduce Remifentanil consumption by 15% while maintaining effective pain control. The study employs a double-blind, placebo-controlled design to ensure unbiased results.

Who should consider this trial

Good fit: Ideal candidates are ICU patients over 18 years old who require sedation for mechanical ventilation for at least 48 hours.

Not a fit: Patients who are likely to need less than 48 hours of mechanical ventilation or have contraindications to the study medications may not benefit.

Why it matters

Potential benefit: If successful, this approach could significantly reduce opioid use in ICU patients, minimizing the risk of opioid-related side effects.

How similar studies have performed: Previous studies have shown promise in using multimodal analgesia to reduce opioid consumption, suggesting this approach may be effective.

Eligibility criteria

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 : paracetamol, nefopam, tramadol, ketamine, remifentanil.
* Patient with hepatic insufficiency (defined as PT \< 50%).
* Parturient or breast-feeding patient.
* Patient suffering from moderate to severe Acute Respiratory Distress Syndrome (ARDS), with decreased PaO2/FiO2 ratio under 150mmHg after respiratory optimization (courant volume 6mL/kg and PEEP \> 5mbar).
* Patient requiring curare treatment.
* Patients with an indication for locoregional analgesia prior to extubation (perineural sealing, epidural analgesia).

Where this trial is running

Nîmes, Gard

• Remy WIDEHEM — Nîmes, Gard, France (Recruiting)

Study contacts

• Study coordinator: Remy WIDEHEM, Dr.

Conditions Intubation; orotracheal intubation; mechanical ventilation; sedation analgesia