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A randomised, double-blind, comparative clinical trial of the effectiveness and tolerability of fentanyl in continuous parenteral perfusion versus on-demand bolus of morphine for the treatment of refractory dyspnoea in patients hospitalised for acute dec

Status
Not yet recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-520025-36-00
Acronym
ESTUDIO FEMODRIC
Enrollment
28
Registered
2025-01-27
Start date
Unknown
Completion date
Unknown
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

being metabolized in the liver to inactive metabolites; urinary excretion of unchanged fentanyl is less than 10% 34., compared with the administration of morphine in BSC on demand, especially to fatty tissue, Fentanyl [N-(1-fentanyl-4-piperidyl) propionanilide citrate (1:1)] is a synthetic opioid agonist developed in 1960. It has a rapid onset of action intravenously (<30 seconds) with a long half-life. between 2 and 4 hours and a duration of action between 30 and 60 minutes. It easily crosses the blood-brain barrier with an equilibrium between plasma and cerebrospinal fluid within 5 minutes of intravenous administration. Plasma levels decrease rapidly due to body redistribution, for the treatment of refractory dyspnea in patients hospitalized for acute decompensation of HF., To evaluate the effectiveness and tolerability of fentanyl in PCSC

Brief summary

Reduction in the average daily intensity of dyspnea is the main criterion of effectiveness. The intensity of dyspnea is evaluated by the patient himself using a Verbal Numerical Scale (EVN) and a Visual Analogue Scale (VAS) of dyspnea 56. The effectiveness of the treatment is evaluated by comparing the EVN and VAS of dyspnea in the first evaluation or 0h with the EVN and VAS of dyspnea in the following consecutive evaluations or 24h, 48h and 72h.

Interventions

DRUGFENTANYL
DRUGFentanilo Medlink 50 microgramas/ml solução injetável

Sponsors

Fundacio Assistencial De Mutua De Terrassa Fpc
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Reduction in the average daily intensity of dyspnea is the main criterion of effectiveness. The intensity of dyspnea is evaluated by the patient himself using a Verbal Numerical Scale (EVN) and a Visual Analogue Scale (VAS) of dyspnea 56. The effectiveness of the treatment is evaluated by comparing the EVN and VAS of dyspnea in the first evaluation or 0h with the EVN and VAS of dyspnea in the following consecutive evaluations or 24h, 48h and 72h.

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026