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

To determine the effect of Montelukast tablets on respiratory complications detected in patients with multiple trauma suffering from lung injury

Phase 2 clinical trial with control group, with parallel, double blind and randomized groups (En block randomization - Individual Random Unit- Using a sealed envelope). One group receives medication (Montelukast) and the other Group recieves placebo. The sample size is 60 patients in both groups.

The study site is Shahid Rajaee trauma hospital of Shiraz. Patients who have inclusion criteria, will be randomly divided into either drug or placebo groups. Standard care will be provided for patients and they will follow for 7 days. Computed tomography is performed on the day of entry and on the seventh day and results are recorded. The study is blinded to participants, carers, evaluators, and analyzers.

Inclusion Criteria: 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, Exclusion Criteria: 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

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) the same as Monteleukast tablets, Orally, Once daily for 7 days

CT scan findings about volume and location of lung contusion; Pulmonary complication like acute lung injury, acute respiratory distress syndrome and pneumonia

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.

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.

The baseline, clinical, and outcome measures databases would be available in SPSS format after publication of the study

The data will be available immediately after publication of the study

The data would be available to the readers of published article through the journals website

There is not limitation for accessing the study data after publication

The database would be available as an appendix to the published article

The database would be available as an appendix to the published article. The availability would be according to the publishers policy