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IRCT20211112053042N2 IRCT 2021-12-06 Karaj University of Medical Sciences The effect of morphine with nebulizer mask in the treatment of acute respiratory distress in adult patients with Covid-19 Evaluation of efficacy and safety of morphine through nebulizer mask in the treatment of acute respiratory distress due to Covid-19 in adult patients 2021-12-20 anticipated 60 Complete https://irct.ir/trial/60236 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are divided into two groups based on a table of random numbers. Random number table is a set of numbers that are produced without a specific pattern or order and in a completely random manner and become a table. In order to use a random number table, the researcher must first predetermine the table to read the numbers (for example, up, down, left, or right). Individual for the control group). The researcher then touches one of the numbers and moves in one of the predetermined directions and records the numbers and assigns them to different groups, Blinding description: The patients (intervention or control) will receive encoded sealed envelopes. The coding will be done by one of the project partners and the doctor, the evaluator and the patient will be blind. 2-3 Acute respiratory distress caused by Covid-19. Intervention 1: Intervention group: Patients receive morphine with a nebulizer mask immediately after admission to the ward or emergency room. Intervention 2: Control group: Patients receive normal saline with a nebulizer mask immediately after admission to the ward or emergency room. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals. When: Access period starts 6 months after the results are published. To whom: Research centers and faculty members Conditions: At the request of the researcher and faculty members Where to obtain: Send email to the scientific respondent How to obtain: Within two months from the time of requesting and sending the email, the documents will be sent to the mentioned people Comments:
public Mohammad Hossein Delshad MD.
Arghavan Gharbi, 45 meters from Golshahr Street, Karaj, Alborz Province
Karaj Iran (Islamic Republic of) 3198683639 +98 26 3350 2347 m.delshad@abzums.ac.ir Karaj University of Medical Sciences scientific Mohammad Hossein Delshad MD.
Arghavan Gharbi, 45 meters from Golshahr Street, Karaj, Alborz Province
Karaj Iran (Islamic Republic of) 3198683639 +98 26 3350 2347 m.delshad@abzums.ac.ir Karaj University of Medical Sciences Iran (Islamic Republic of) Age 80-18 years Patients with a definitive diagnosis of Covid-19 based on PCR test within 48 hours after hospitalization Acute moderate respiratory distress syndrome with PaO2 / FiO2 <200 based on Berlin criteria (Force et al., 2012) Patients with severe dyspnea Patients in the end-stages of the disease Lack of proper treatment Patients with consent to participate in the project 18 years 80 years Both Patients with high suspicion / diagnosis of heart failure and unstable angina Existence of severe shock with hemodynamic instability despite increased vascular pressure Severe / undiagnosed lung infection for other reasons (chronic obstructive pulmonary disease, pulmonary fibrosis, lung cancer, bacterial pneumonia ...) Diagnosis of pulmonary hemorrhage Pregnancy / breastfeeding An important cause other than acute respiratory distress for respiratory failure Requires ECMO during the study period He/she is expected to be transferred to another hospital within 72 hours Known allergies to morphine Sensitivity or contraindication to exogenous and endogenous opioids Obesity (BMI>35 kg/m2 ) Patients with dissatisfaction with participating in the project B97.2 Coronavirus as the cause of diseases classified to other chapters Treatment - Drugs Treatment - Drugs Intervention group: Patients receive morphine with a nebulizer mask immediately after admission to the ward or emergency room. Control group: Patients receive normal saline with a nebulizer mask immediately after admission to the ward or emergency room. Mortality rate. Timepoint: During hospitalization. Method of measurement: Based on the patient's record. Oxygen saturation level. Timepoint: Morphine dose before titration, 2 hours after first titration, 2 hours after second titration, 2 hours after third titration, 2 hours after effective drug titration, 12 hours after effective drug titration, 24 hours after effective drug titration. Method of measurement: Pulse oximetry. Karaj University of Medical Sciences Approved 2021-10-16 Ethics committee of Alborz University of Medical Sciences second floor, Deputy of Research and Technology, Saffarian Alley, 45 meters from Golshahr, Karaj. Karaj Alborz Iran (Islamic Republic of)