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NCT05825560

OPIOID-FREE ANALGESIA IN ICU IN INTENSIVE CARE UNIT

OPIOID-FREE ANALGESIA IN INTENSIVE CARE UNIT : A PROSPECTIVE, MONOCENTRIC, RANDOMIZED, DOUBLE-BLIND, FEASIBILITY CLINICAL TRIAL
Centre Hospitalier Universitaire de Nīmes·Phase 4·ClinicalTrials.gov·drugNot yet recruiting
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Study focus
Disease/Condition
Intubation
Drug/Device/Intervention
OFA multimodal analgesia
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Centre Hospitalier Universitaire de Nīmes
Location
Nîmes, France
Timeline & enrollment
Phase
Phase 4
Start date
Jun 01, 2023
End date
Apr 01, 2025
Enrollment
50 participants
Primary outcome

Daily remifentanil consumption (after randomisation)

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, we 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. We conducted a
 prospective, ''proof of concept'', randomized, double-blind, parallel group,
 placebo-controlled trial. We studied multimodal analgesia versus standard-of-care in ICU
 patients requiring sedation-analgesia for invasive mechanical ventilation.We hypothesized
 that Remifentanil consumption decrease by 15% with the use of a standardized multimodal
 analgesia strategy

ICD-10 classifications
Failed or difficult intubationFailed or difficult intubation during labour and deliveryFailed or difficult intubation during pregnancyFailed or difficult intubation during the puerperiumRespiratory arrest
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05825560
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05825560 through Pure Global AI's free database. This Phase 4 trial is sponsored by Centre Hospitalier Universitaire de Nīmes and is currently Not yet recruiting. The study focuses on Intubation. Target enrollment is 50 participants.

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