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IRCT20201226049832N1 IRCT 2021-04-19 Shahroud University of Medical Sciences Comparison of the effect of fentanyl with fentanyl and midazolam in pain control Comparison of the effect of fentanyl with fentanyl and midazolam in controlling pain in trauma patients 2021-04-25 anticipated 78 Complete https://irct.ir/trial/53522 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Other, Randomization description: Patients will be randomly divided into 2 groups of 39 using Random allocation software.From the first eligible patient, the criteria for inclusion of treatment allocation based on randomization will beginInitially, the number 1 to 78 will be written on 78 envelopes, respectively.Then, inside each envelope, a sheet containing the code of the type of treatment of each patient will be specified based on the Random allocation software, which will determine the treatment of each patient.The written consent form of the study will be placed .After the arrival of each patient or identification in accordance with the criteria for entering an envelope in the order of the numbers that the type of treatment will be assigned in code, Blinding description: Participant: The use of placebo in addition to the current drug in one group of fentanyl and normal saline injections and in the second group of fentanyl and midazolam injections. Outcome Evaluator: Measuring the patient's pain before and after the intervention by an emergency medicine resident who is unaware of how medications are administered to the patient.The data analyzer is not aware of how drugs are assigned to groups. 3 Trauma. Intervention 1: Fentanyl injection based on weight levels (Weight 40 to 50 kg at 45 micrograms. Weight 50 to 60 kg at 55 micrograms. Weight 60 to 70 micrograms at 65 micrograms. Weight 70 to 80 kg at 75 micrograms. Weight 80 to 90 kg at 85 micrograms. Weight 90 to 100 kg and above 100 micrograms) and inject one milligram of normal saline. Intervention 2: Intervention group: Intravenous midazolam injection (1 mg under 50 kg. 2 mg 50 to 75 kg and 3 mg over 75 kg weight) and intravenous fentanyl injection based on weight levels (40 to 50 kg at 45 μg. 50 to 60 kg at 55 μg) Weight 60 to 70 micrograms at a rate of 65 micrograms. Weight 70 to 80 kg at a rate of 75 micrograms. Weight 80 to 90 kg at a rate of 85 micrograms. Weight 90 to 100 kg and above 100 micrograms). Yes - There is a plan to make this available What will be shared: All collected data will be shared after identifying individuals and analyzing them. When: The end of the year 1401 To whom: For all researchers Conditions: For use in studies Where to obtain: Supervisor How to obtain: Justification for use via email correspondence Comments:
public mozhgan sabzevari
Shahroud. 7th Tir Square. Shahroud University of Medical Sciences. School of Medicine. Third floor. Room 409
shahrood Iran (Islamic Republic of) 3614773947 +98 23 3239 5009 dr.sabzevari7@gmail.com Shahroud University of Medical Sciences scientific Mozhgan Sabzevari
Shahroud, Tehran St., 7th of Tir Square, Shahroud University of Medical Sciences, School of Medicine, Second Floor, Research Deputy
Shahrood Iran (Islamic Republic of) 3614773947 +98 23 3239 5009 dr.sabzevari7@gmail.com Shahroud University of Medical Sciences Iran (Islamic Republic of) People in the age group of 18 to 80 year Mechanism of trauma multiple trauma and direct trauma Obtaining informed consent Stable hemodynamic status (including patients with systolic blood pressure above 90 mm Hg) Patient consciousness is complete (GCS = 15) 18 years 80 years Both Pregnancy.Mentally retarded patients Mentally retarded patients Consumption of psychotropic drugs Drug addicted patients G89.11 Acute pain due to trauma Treatment - Drugs Treatment - Drugs Fentanyl injection based on weight levels (Weight 40 to 50 kg at 45 micrograms. Weight 50 to 60 kg at 55 micrograms. Weight 60 to 70 micrograms at 65 micrograms. Weight 70 to 80 kg at 75 micrograms. Weight 80 to 90 kg at 85 micrograms. Weight 90 to 100 kg and above 100 micrograms) and inject one milligram of normal saline Intervention group: Intravenous midazolam injection (1 mg under 50 kg. 2 mg 50 to 75 kg and 3 mg over 75 kg weight) and intravenous fentanyl injection based on weight levels (40 to 50 kg at 45 μg. 50 to 60 kg at 55 μg) Weight 60 to 70 micrograms at a rate of 65 micrograms. Weight 70 to 80 kg at a rate of 75 micrograms. Weight 80 to 90 kg at a rate of 85 micrograms. Weight 90 to 100 kg and above 100 micrograms) Pain control in patient trauma. Timepoint: at the time of referral , 30 and 60 minutes after the intervention. Method of measurement: using the Visual Analogue Scale. Side effects of medications. Timepoint: 30 and 60 minutes after the intervention. Method of measurement: Examination by a specialist. Level of anxiety. Timepoint: At the time of referral, 60 minutes after referral. Method of measurement: Depression Anxiety Stress Scale. Shahroud University of Medical Sciences Approved 2021-03-08 research ethic committee Shahroud university of medial science Shahroud University of Medical Sciences and Health Services, Hafte Tir Square Shahroud Semnan Iran (Islamic Republic of)