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OPIOID-FREE ANALGESIA IN ICU IN INTENSIVE CARE UNIT - Trial NCT05825560

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 Nฤซmes and is currently Not yet recruiting. The study focuses on Intubation. Target enrollment is 50 participants.

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NCT05825560
Phase 4
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05825560
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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

Study Focus

Intubation

OFA multimodal analgesia

Interventional

drug

Sponsor & Location

Centre Hospitalier Universitaire de Nฤซmes

Nรฎmes, France

Timeline & Enrollment

Phase 4

Jun 01, 2023

Apr 01, 2025

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 intubation
Failed or difficult intubation during labour and delivery
Failed or difficult intubation during pregnancy
Failed or difficult intubation during the puerperium
Respiratory arrest

Data Source

ClinicalTrials.gov

NCT05825560

Non-Device Trial