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IRCT20200521047530N2 IRCT 2020-09-29 Tehran University of Medical Sciences The comparison study of midazolam and promethazine premedication in MRI outpatients The comparison study of midazolam and promethazine premedication in MRI outpatients undergone general anesthesia in children, imaging ward of children's medical center 2020 2020-10-22 anticipated 116 Complete https://irct.ir/trial/50729 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method of this study will be block randomization. Thus, using random generators, 4 blocks consisting of promethazine and midazolam groups will be formed. The process of assigning patients to the two study groups will be performed by a trained nurse (outside the research team) and the researchers in this study will not be aware of the allocation process(allocation concealment), Blinding description: The patient himself is unaware of which category he falls into And what kind of anesthetic is given to him. The researcher is also unaware of what kind of medicine is given to each patient. The process of assigning patients to the two study groups will be performed by a trained nurse (outside the research team) and the researchers in this study will not be aware of the allocation process.The data will be collected by a researcher who is unaware of the classification of patients. N/A patients candidate for MRI. Intervention 1: Intervention group: Promethazine/ Half an hour before separation, 1 mg / kg promethazine (with 20 cc of sugar water) will be given. Intervention 2: Control group: midazolam/ Half an hour before separation, 0.3 mg / kg midazolam (with 20 cc of sugar water) will be given. Yes - There is a plan to make this available What will be shared: The data will be published in general and in the form of a general report. No personal information or names of study participants will be disclosed. When: The results will be available from 1400 and after the results are published. To whom: Access will be available to everyone. Conditions: Access will be available to everyone. It will be possible for all people to use the results and data. Where to obtain: email:nima.nazari1366@gmail.com Dr. Nima Nazari/ Assistant Professor if Anesthesiology- Tehran University of medical sciences How to obtain: The request for data submission will be sent to the mentioned email.The data will then be available to everyone. Comments:
public Nima Nazari
Keshavarz Blvd- Gharib St- Children's medical center Hospital
Tehran Iran (Islamic Republic of) 1419733151 00982161479 nima.nazari1366@gmail.com Tehran University of Medical Sciences scientific Nima Nazari
Keshavarz Blvd- Ghrib St- Children's medical center hospital
Tehran Iran (Islamic Republic of) 1419733151 00982161479 nima.nazari1366@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) All patients aged 1 to 10 years old ASA class 1 and 2 Patients who have referred to the Pediatric Medical Center Hospital for outpatient MRI under anesthesia. 1 year 10 years Both Dissatisfaction of parents to participate in the project Genetic and congenital diseases History of allergy to the studied drugs behavioral disorders Use of psychiatric drugs and any mental disorders in the child Use sleeping pills before visiting Patients with ASA grade 3 and above Non-Persian speaking family Treatment - Drugs Treatment - Drugs Intervention group: Promethazine/ Half an hour before separation, 1 mg / kg promethazine (with 20 cc of sugar water) will be given. Control group: midazolam/ Half an hour before separation, 0.3 mg / kg midazolam (with 20 cc of sugar water) will be given. Sedation criteria. Timepoint: Measure immediately after entering recovery. Method of measurement: RAMSAY criteria score. Delirium emergence score. Timepoint: Measure immediately after entering recovery. Method of measurement: PAED score. Recovery time. Timepoint: After entering the recovery. Method of measurement: Interval from admission to recovery ward until discharge. Sedation score. Timepoint: After entering the recovery. Method of measurement: Ramsay Score. Delirium emergence score. Timepoint: After entering the recovery. Method of measurement: PAED score. Nurses' satisfaction. Timepoint: After entering the recovery. Method of measurement: RN satisfaction score. Nausea and vomiting. Timepoint: After entering the recovery. Method of measurement: View. Bronchospasm and laryngospasm. Timepoint: After entering the recovery. Method of measurement: Observation of symptoms and auscultation. Tehran University of Medical Sciences Approved 2020-07-11 Ethics Committee of Tehran University of Medical Sciences Keshvarz Blvd- Qods St- Central building of Tehran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)