Opioid-free Analgesia in Intensive Care Unit

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-15

Study Completion Date

2026-08-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of an Opioid-Free Anesthesia Protocol Versus Standard Practices on Early and Late Post-operative Recovery

NCT04797312

Anesthesia Anesthesia; Adverse Effect Opioid Analgesic Adverse Reaction +1 more

UNKNOWN PHASE3

Treatment of Procedural Pain Associated With Turning in Patients With Mechanical Ventilation

NCT01950000

Critical Illness Pain

COMPLETED PHASE4

Effect of Patient Preference for Intraoperative Opioid Use on Early Postoperative Quality of Recovery

NCT06855641

Opioid Analgesia Quality of Recovery (QoR-15) Outcome Assessment +1 more

COMPLETED NA

Efficacy and Safety of Oxycodone Hydrochloride for Long-term Analgesia in ICU Patients

NCT06444997

Oxycodone Analgesia Mechanical Ventilation +2 more

NOT_YET_RECRUITING PHASE4

Opioid Free Anesthesia vs. Opioid Anesthesia Techniques.

NCT03367988

Analgesic Drug Dependence Colectomy

UNKNOWN PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

ICU patients requiring sedation-analgesia for mechanical ventilation for at least 48 hours are randomized in 2 parallel groups : control arm using ''standard of care'' analgesia (Paracetamol and Remifentanil), and interventional arm using multimodal analgesia at different level according to pain accessed by BPS (Step 1 : Paracetamol, Nefopam, Tramadol, Step 2 : Ketamine, Step 3 : Remifentanil). Sedation drugs are standard of care (Propofol and Midazolam if Propofol isn't enough) to obtain prescribed sedation accessed by RASS. Double-bling is kept for 72 hours until the primary outcome is obtained.

The investigators hypothesize a 15% reduction of Remifentanil consumption in the interventional group.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intubation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

Analgesia combines paracetamol (1g every 6 to 8 hours according to age and weight recommendations) and remifentanil, adapted according to a tiered administration system depending on the Behavior Pain Scale (BPS) and the theoretical ideal weight. Remifentanil doses are adjusted so that the patient has a BPS score of 4 or less. Reassessment of analgesia will be carried out every 30 minutes until analgesic adaptation is complete, then every 2 hours as is usually done in our department.

If the BPS is less than or equal to 4, the therapeutic de-escalation will be done with a reverse algorithm until the analgesic drugs are stopped.

After the sedation balance phase, the patient's BPS will be assessed every 2 hours.

Group Type ACTIVE_COMPARATOR

Standard multimodal analgesia

Intervention Type DRUG

Standard remifentanil analgesia

OFA Group

A fixed combination of nefopam and tramadol will be initiated at daily doses. An initial dose of 50mg tramadol and 20mg nefopam IV over 30 min. will be administered. Reassessment of analgesia will be performed every 30 min. for two hour and then every 2 hours.

* If BPS is \> 4, administration of ketamine with an initial bolus of 0.15mg/kg followed by continuous administration at a dose of 0.15mg/kg/hour.
* If the BPS is \< 4, remifentanil is introduced at the minimum effective dose, in a stepwise fashion according to the theoretical ideal weight
* In the event of maximum pain requiring the full range of therapies in the algorithm the total dose of tramadol will be 450mg/day and nefopam 120mg/day, in accordance with summaries of product characteristics.
* If the BPS \< or = 4, the therapeutic de-escalation will be done with a reverse algorithm until the analgesic drugs are stopped, according to the following scheme: remifentanil, ketamine, tramadol and then nefopam.

Group Type EXPERIMENTAL

OFA multimodal analgesia

Intervention Type DRUG

Multimodal opioid free analgesia

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

OFA multimodal analgesia

Multimodal opioid free analgesia

Intervention Type DRUG

Standard multimodal analgesia

Standard remifentanil analgesia

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No