Opioid-free Analgesia in Intensive Care Unit

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NĪMES · Apr 11, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new way to manage pain for patients in the Intensive Care Unit (ICU) who need help breathing with a ventilator. Typically, these patients experience moderate to severe pain, and the study is exploring a pain management approach that uses a combination of medications—like paracetamol, nefopam, tramadol, ketamine, and remifentanil—rather than relying only on standard treatments. The goal is to see if this combination can reduce the amount of remifentanil needed by 15%, which could help decrease side effects associated with opioid medications.

To participate in the study, patients must be adults over 18 years old who are in the ICU and require sedation and pain relief for mechanical ventilation lasting between 2 to 24 hours. Participants will be randomly assigned to receive either the new combination of medications or the standard treatment, and they will be closely monitored throughout the process. It's important to note that certain patients, such as those with specific allergies to the study medications or those needing less than 48 hours of ventilation, may not be eligible to join. Overall, this trial aims to find safer and more effective ways to manage pain in critically ill patients.

Gender

ALL

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).