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A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying the treatment of refractory dyspnea, which is a type of severe shortness of breath that does not improve with standard treatments. This condition often affects patients who are hospitalized due to an acute worsening of heart failure. The study aims to compare the effectiveness and tolerability of two medications: fentanyl and morphine. Fentanyl is a powerful pain-relieving medication that works quickly when given intravenously, while morphine is another well-known pain reliever often used in hospitals.
The purpose of the study is to evaluate how well fentanyl works compared to morphine in relieving the symptoms of refractory dyspnea in patients with heart failure. Participants in the study will receive either continuous doses of fentanyl or on-demand doses of morphine. The study is designed to be double-blind, meaning neither the patients nor the healthcare providers will know which medication is being administered to ensure unbiased results.
Throughout the study, participants will be monitored to assess the reduction in the intensity of their dyspnea. This will be measured using simple scales that the patients can easily understand and use. The study will last for a period of time during which the effectiveness and any side effects of the treatments will be closely observed. The goal is to determine which medication provides better relief for patients suffering from this challenging condition.
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
7 criteria
5 criteria
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is a strong pain medication used in this trial to help manage severe breathing difficulties in patients. It is given continuously through a method called parenteral perfusion, which means it is delivered directly into the bloodstream to provide a steady effect.
is another powerful pain medication used in this trial. It is given to patients as needed, in doses that are administered when the patient experiences severe breathing problems. This method is known as on-demand bolus administration.
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Czechiasourced from the EU Clinical Trials Register and site verification
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