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IRCT201603089014N94 IRCT 2016-03-27 Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences Comparison of the effect of ketorolac, morphine, and apotel in patients with head trauma Comparison of the effect of ketorolac, morphine, and apotel in patients with head trauma: a double-blind randomized clinical trial 2016-04-20 anticipated 105 Complete https://irct.ir/trial/9532 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: , Randomization description: Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group, Blinding description: Medications will be prepared the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double-blind. 2 Head trauma. Intervention 1: Single dose infusion of apotel 15 mg/kg in 100 ml normal saline during 15 min. Intervention 2: Single dose infusion of ketorolac 30 mg/kg in 100 ml normal saline during 15 min. Intervention 3: Single dose infusion of morphine 1 mg/kg in 100 ml normal saline during 15 min. 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 It depends on the situations and the results of the study as well as approval of the financial supporting organization.
public Dr Alireza Azimi Far
Besat Hospital, Shahed Square
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3364 0030 azimi_a1122@yahoo.com Besat Hospital scientific Dr Rasoul Salimi
Besat Hospital, Shahed Square
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3364 0030 rasoulsl@yahoo.com Besat Hospital Iran (Islamic Republic of) age of 15 to 50 years; head trauma during 24 hours severity of headache equal to or greater than 4 based on VAS 20 years 50 years Both Decreased consciousness Abnormal neurologic findings Hemorrhagic and pathologic findings in brain CT scan A history of hemorrhagic disorders or using anti-coagulant agents A history of chronic headaches Multiple trauma Asthma Addiction Pregnancy Renal failure, liver disease, cardiovascular diseases, pulmonary diseases S09 Other and unspecified injuries of head Treatment - Drugs Treatment - Drugs Treatment - Drugs Single dose infusion of apotel 15 mg/kg in 100 ml normal saline during 15 min Single dose infusion of ketorolac 30 mg/kg in 100 ml normal saline during 15 min Single dose infusion of morphine 1 mg/kg in 100 ml normal saline during 15 min Measuring the severity of headache. Timepoint: before, and 15 and 30 min after intervention. Method of measurement: using visual analog scale (VAS). Assessing probable drug side effects (such as nausea, vomiting, dizziness, itching). Timepoint: 15 and 30 min after intervention. Method of measurement: by question. Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences Approved 2016-02-27 Ethics Committee of Hamadan University of Medical Sciences Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Hamadan Iran (Islamic Republic of)