A multicenter, open-label, randomized of MOrphine and MEperidine in patients admitted for acute heart failure in emergency departments: the MOME study

INTERVENTION: Product Name: meperidina Pharmaceutical Form: Solution for injection INN or Proposed INN: PETHIDINE CAS Number: 57‐42‐1 Product Name: morphine hydroclorure Pharmaceutical Form: Solution for injection INN or Proposed INN: MORPHINE HYDROCHLORIDE CAS Number: 52‐26‐6 Other descriptive name: MORPHINE HYDROCHLORIDE CONDITION: Acute heart failure is the rapid development or change of signs and symptoms of heart failure that requires medical attention and usually leads to patient hospitalization ; MedDRA version: 19.0 Level: LLT Classification code 10000803 Term: Acute heart failure System Organ Class: 100000004849 Therapeutic area: Diseases [C] ‐ Cardiovascular Diseases [C14] PRIMARY OUTCOME: Main Objective: Our objective is to assess in‐hospital mortality; associated with intravenous opioids use(morphine vs meperidine) in patients with acute heart failure Primary end point(s): In‐hospital mortality Secondary Objective: a) Need to patient to require mechanical ventilation.; b) Stay in hospital; c) Time and admission rate in the intensive care unit; d) Need to patient to require cardiopulmonary resuscitation. Timepoint(s) of evaluation of this end point: During the hospitalization. SECONDARY OUTCOME: Secondary end point(s): a) Need to patient to require mechanical ventilation.; b) Stay in hospital; c) Time and admission rate in the intensive care unit; d) Need to patient to require cardiopulmonary resuscitation. Timepoint(s) of evaluation of this end point: During the hospitalization. INCLUSION CRITERIA: Patients admitted for acute heart failure in emergency departments and the following characteristics: ‐ Adults more than 18 years of age. ‐ Patients with anxiety and distress associated with dyspnoea. ‐ Being willing and able to provide informed consent after written and oral information. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 56