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IRCT20141127020112N7 IRCT 2018-10-19 Iran University of Medical Sciences Effect of Zolpidem and Midazolam on anxiety of children Comparison of oral Midazolam with oral Zolpidem on the anxiety of children undergoing eye evaluation under general anesthesia 2018-07-27 anticipated 56 Complete https://irct.ir/trial/32914 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly divided into 2 groups. Randomization is done by a computer program and the host does not know. For random assignment, the rand-between command in Excel software is used. Individuals with an even code are assigned to the Midazolam group and individuals with the odd code are assigned to the Zolpidem group, Blinding description: Both medicines given to patients ,are dissolved in same juice and kept in the same containers. The parents of patients and the collectors of the data, do not know the type of drug administered to the child. 3 Anxiety in children before surgery. Intervention 1: Intervention group 1: 0.25 mg/kg of midazolam ; oral use; 30 minutes before surgery. Intervention 2: Intervention group 2: 0.25 mg/kg of zolpidem; oral; 30 minutes before surgery. Yes - There is a plan to make this available What will be shared: The total potential data can be shared after making people unidentifiable When: Start the access period 6 months after printing the results To whom: Data will be available to researchers working in academia and, and those in the industry can also take action. Conditions: Uses that lead to better interaction between the physician and the surgeon with the patient And reducing parental stress and worries Where to obtain: Pooya_derakhshan@bums.ac.ir Anesthesiology department, Hazrat rasool complex,Sattar khan Ave.Postal code:Pooya_derakhshan@bums.ac.ir How to obtain: After six months from the publication of the article, qualified people can immediately receive the data by mentioning the reasons for the need for the data. Comments:
public Pooya derakhshan
Hazrat Rasool medical complex, Niayesh ave, Sattar Khan street
Tehran Iran (Islamic Republic of) ۱۴۴۵۶۱۳۱۳۱ +98 56 3234 1410 pooya_derakhshan@bums.ac.ir Iran University of Medical Sciences scientific Pooya Derakhshan
Hazrat Rasool medical complex, Niayesh ave, Sattar Khan street
Tehran Iran (Islamic Republic of) ۱۴۴۵۶۱۳۱۳۱ +98 56 3234 1410 pooya_derakhshan@bums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Pediatric patients ages 2-9 years ASA class I-II undergoing eye evaluation under general anesthesia 2 years 9 years Both contraindication to preoperative sedation, known allergy or sensitivity to the study medications parents' unwillingness on the children's participation in the study Patients with weights below the 5th percentile or above the 95th percentile according to the current published CDC growth chart Children with metabolic, endocrine, cardiac, pulmonary or hepatic diseases Treatment - Drugs Treatment - Drugs Intervention group 1: 0.25 mg/kg of midazolam ; oral use; 30 minutes before surgery. Intervention group 2: 0.25 mg/kg of zolpidem; oral; 30 minutes before surgery. Anxiety score. Timepoint: Measuring the anxiety level at the beginning of the study (before the intervention) and thirty minutes after taking the drug. Method of measurement: Modified Yale preoperative anxiety scale. Iran University of Medical Sciences Approved 2017-10-14 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Next to Milad tower, Hemmat highway Tehran Tehran Iran (Islamic Republic of)