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IRCT20190719044270N1 IRCT 2019-11-08 Bagheiat-allah University of Medical Sciences The effect of Montelukast on respiratory complications detected in patients with multiple trauma and lung injury A study to evaluate the effect of Montelukast tablets on respiratory complications in patients with multiple trauma suffering from lung injury; a double blind randomized clinical trial 2019-09-23 anticipated 60 Complete https://irct.ir/trial/40947 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: block randomization - Individual Random Unit- Using a sealed envelope. We Use "Random allocation Software" to allocate 60 patients into Two Groups randomly by using blocks size of 4. These random numbers and drugs (placebo or true medication) are placed in envelopes and then, as each patient arrives, an envelope is opened and treatment is applied to each individual. Obviously, the drug in the envelope is also not detectable for staffs in terms of being a placebo or true medication, Blinding description: The placebo tablets will be provided in the same color, shape, size, and weight as the Monteleukast tablets .They will be packaged in the same packages, too. A unique number will be written on each package (Monteleukast or placebo). This number and its corresponding contents (Monteleukast or placebo) will be recorded by the researcher. The numbered packages will be provided to the patient's nurse. The nurses will be asked to record the numbers on the package in the relevant form after being used by the patient and obtaining the medical, clinical and laboratory data. Consequently, the nurses, staffs, and patients will only encountered the numbers on the packages but not their content. After removing the participant name from the CT images, a unique number will be lithographed on each image. As a result, the radiologist will be unaware of the patient's name and the therapy. The Radiologist will record the number after reporting the images on the report form. Only the researcher will have access to the corresponding names and numbers. After the therapy course a new CT scan will be done. The patients names will be removed in the first step .A new number, independent of the numbers written on the pre-treatment images, will be lithographed on the new images. Consequently, the radiologist will be blind to therapy effect in the follow-up images. Finally, the data will be entered in a statistical analysis software. The case and control groups will be labeled as group A and B. Afterward, the statistical information will be sent to the statistical specialist, who is blind to case and control group. 2 Condition 1: Contusion of lung. Condition 2: Multiple fractures of ribs. Condition 3: Acute respiratory distress syndrome. Condition 4: Pneumonia. Condition 5: Pulmonary embolism. Intervention 1: Intervention group: Airokast® (Montelukast -as sodium- Abidi company) 10 mg Orally, Once daily for 7 days. Intervention 2: Control group: Placebo pills (Produced in the Faculty of Pharmacy, Shiraz University of Medical Sciences) like real drug, Orally, Once daily for 7 days. Yes - There is a plan to make this available What will be shared: The baseline, clinical, and outcome measures databases would be available in SPSS format after publication of the study When: The data will be available immediately after publication of the study To whom: The data would be available to the readers of published article through the journals website Conditions: There is not limitation for accessing the study data after publication Where to obtain: The database would be available as an appendix to the published article How to obtain: The database would be available as an appendix to the published article. The availability would be according to the publishers policy Comments:
public Ali Taheri Akerdi
Shahid Rajaei Hospital, Chamran Avenue, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7194815711 +98 71 3625 4206 ata110iran@gmail.com Bagheiat-allah University of Medical Sciences scientific Ali Taheri Akerdi
Shahid Rajaei Hospital, Chamran Avenue, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7194815711 +98 71 3625 4206 ata110iran@gmail.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Patients with blunt multiple trauma and at least 3 fractured ribs Patients with blunt multiple trauma and lung contusion detected in CT scan performed on arrival 16 years no limit Both Patients younger than 16 years Patients with penetrating trauma Patients with history of cardiopulmonary disease Patients with history of hypersensitivity to Montelukast Patients who will not sign the informed written consent S27.32 S22.4 J80 B95.3 I26 Contusion of lung Multiple fractures of ribs Acute respiratory distress syndrome Streptococcus pneumoniae as the cause of diseases classified elsewhere Pulmonary embolism Prevention Placebo Intervention group: Airokast® (Montelukast -as sodium- Abidi company) 10 mg Orally, Once daily for 7 days Control group: Placebo pills (Produced in the Faculty of Pharmacy, Shiraz University of Medical Sciences) like real drug, Orally, Once daily for 7 days Lung contusion. Timepoint: on day 0 and 7. Method of measurement: Chest CT-scan. Acute Lung Injury. Timepoint: on day 7. Method of measurement: Chest CT-scan. Acute Respiratory Distress Syndrome. Timepoint: on day 7. Method of measurement: Chest CT-scan. Pulmonary Emboli. Timepoint: on day 7. Method of measurement: Chest CT angiography. Pneumonia. Timepoint: on day 7. Method of measurement: Chest CTscan. C reactive Protein. Timepoint: day 0 and 3. Method of measurement: Serum agglutination test. Procalcitonin. Timepoint: day 3. Method of measurement: Blood level of procalcitonin. Length of ICU stay. Timepoint: Discharge from ICU. Method of measurement: counting ICU admission days. Days underwent ventilator assisted respiration. Timepoint: on discharge. Method of measurement: counting the days underwent ventilator assisted respiration. Bagheiat-allah University of Medical Sciences Approved 2019-07-08 Ethics Committee affiliated to Baqiyatallah University of Medical Sciences Bagheit_Allah Medical School, South Sheykh Bahaee St, Molasadra St, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)