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IRCT20190912044752N1 IRCT 2019-10-28 Ahvaz University of Medical Sciences Evaluation the Effects of Melatonin on Amount of Opioids Intake Evaluation the Effects of Melatonin versus Placebo on Amount of Opioids Intake in Patients Admitted to Intensive Care Unit 2019-09-23 anticipated 52 Complete https://irct.ir/trial/42675 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individuals are randomly divided into two groups based on simple randomization method using random digits table. In this method, a collection of non-template numbers is randomly generated and arranged as a table. Even numbers for the intervention group and the odd numbers for the control group are considered. According to the number of patients, they are randomly assigned to one of the intervention or placebo groups, Blinding description: Patients, responsible for collecting data and data analyzer are blind to the groups allocation. 3 Traumatic patients. Intervention 1: Intervention group: On arrival at the intensive care unit, the patients will be received melatonin with dose of 3 mg every night until discharge. Intervention 2: Control group: On arrival at the intensive care unit, the patients will be received placebo every night until discharge. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Farahmand Kalantari
Golestan Hospital, Farvardin Ave.
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3374 3037 farahmandbm@gmail.com Ahvaz University of Medical Sciences scientific Farhad Soltani
Golestan Hospital, Farvardin Ave.
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3374 3037 soltani-f@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Age range 18 – 80 year Traumatic patients who are admitted to intensive care unit 18 years 80 years Both Patients with GCS less than 4 Pregnant patients Patients with renal and liver failure Patients with brain tumor Allergic reaction to melatonin Treatment - Drugs Treatment - Drugs Intervention group: On arrival at the intensive care unit, the patients will be received melatonin with dose of 3 mg every night until discharge. Control group: On arrival at the intensive care unit, the patients will be received placebo every night until discharge. The amount of prescribed opioid analgesic medication. Timepoint: Daily from admission and starting intervention to discharge. Method of measurement: Total receiving dose of opioid analgesic medication. Duration of hospitalization. Timepoint: Duration of admission to discharge. Method of measurement: Checklist. The time required for mechanical ventilation. Timepoint: Duration of hospitalization. Method of measurement: Checklist. Rate of mortality. Timepoint: Duration of hospitalization. Method of measurement: The number of patients who died. Ahvaz University of Medical Sciences Approved 2018-02-03 Ethics committee of Ahvaz University of Medical Sciences Research deputy, Ahvaz Jundishapur University Of Medical Sciences, Golestan Blvd. Ahvaz Khouzestan Iran (Islamic Republic of)