Intubation
Conditions
Keywords
orotracheal intubation, mechanical ventilation, sedation analgesia
Brief summary
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
Detailed description
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.
Interventions
DRUGOFA multimodal analgesia
Multimodal opioid free analgesia
Standard remifentanil analgesia
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily remifentanil consumption (after randomisation) | 48th hour after randomisation | daily consumption of remifentanil between the 24th hour and the 48th hour after randomisation of patients admitted to the ICU and requiring at least 48 hours of mechanical ventilation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of a non-opioid analgesia strategy on extubation failure rates | 48 hours after extubation | extubation failure and cause (reintubation within 48 hours of first extubation) |
| Impact of a non-opioid analgesia strategy onICU and hospital length of stay | Day 90 | Length of stay in the intensive care unit and in the hospital |
| Impact of the non-opioid analgesia strategy on vital prognosis at D28 and D90. | Day 90 | Vital status at day 28 and day 90 |
| Impact of a non-opioid analgesia strategy on morphine dependence at D90 | Day 90 | Opioid use at D90 |
| Impact of a non-opioid analgesia strategy on morphine savings at D7 | Day 28 | Cumulative dose of remifentanil |
| Impact of an opioid-free analgesia strategy on sedative consumption | Day 28 | Number of lived days free of remifentanil |
| Impact of a non-opioid analgesia strategy on the duration of mechanical ventilation | Day 28 | Number of live days free of mechanical ventilation |
| Impact of an opioid-free analgesia strategy on norepinephrine | Day 28 | Number of lived days free of norepinephrine |
| Impact of a non-opioid analgesia strategy on organ failure at D28 | Day 28 | SOFA Score (Sepsis-related Organ Failure Assessment) |
| Impact of a non-opioid analgesia strategy on fluid intake | Day 28 | Daily fuid intake in milliliter |
| Impact of a non-opioid analgesia strategy on mental confusion | Day 28 | CAM ICU test |
| Impact of a non-opioid analgesia strategy on the incidence of ventilator-associated pneumonia | Day 28 | Presence of pneumonia associated with mechanical ventilation |
| Impact of a non-opioid analgesia strategy on the occurrence of morphine-related adverse events | Day 28 | Presence of one or more events of special interest or expected adverse events: constipation, bradycardia, bladder globe, nausea, vomiting, liver disturbance, serotonin syndrome |
Countries
France
Outcome results
None listed