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Study aim
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Determination of melatonin effect on the outcome of moderate and severe diffuse axonal injury(DAI) in men admitted to Kerman Educational And Traputical Center Of Shahid Bahonar: changes in inflammatory, oxidant activity, and injury factors
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Design
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The research has two parallel groups with a control group and is double-blind, randomized on 70 patients, randomization will do with random allocation software.
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Settings and conduct
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This study is a double-blind randomized controlled clinical trial (Bahonar Hospital, Kerman). 70 participants are randomly assigned to two groups receiving melatonin and receiving a placebo orally. In the intervention group, 3 mg of melatonin was administered upon admission and from the day after the injury, once a day two hours before bedtime for 4 weeks. The control group takes a placebo. In blinding the patient, the nurse and the researcher are unaware of the nature of the medicine.
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Participants/Inclusion and exclusion criteria
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Inclusion: Male, Age between 18 and 60 years old, Moderate and severe diffuse axonal damage, Less than 4 hours of admission time
Exclusion criteria: brain death, sepsis, electrolyte disorders, use of steroids, hypertension, diabetes, metabolic acidosis, liver trauma, cancer, depression, cardiovascular risk factors, autoimmune diseases, respiratory failure, fractures, severe hypothermia
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Intervention groups
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In the intervention group, 3 mg of melatonin (Razek company) was prescribed at the entrance to the emergency room and from the day after the injury, once a day two hours before going to bed at 22:00 for 4 weeks.
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Main outcome variables
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Primary outcomes: GOS and FIM score at 6 months post-injury and mortality
Secondary outcomes: change in daily GCS score until discharge, hospitalization duration, mortality rate, GCS during discharge, GOS and FIM score in the first and third months after trauma, and chemical factors in 24 hours and 1 month.