]>
IRCT20171009036661N3 IRCT 2018-12-03 Kerman University of Medical Sciences The effect of intranasal midazolam on children sedation The comparison of effectiveness of oral midazolam and intranasal midazolam on sedation of children Comparison of the efficacy of oral midazolam and intranasal midazolam in sedation for diagnostic procedures (radiology and sonography, CT scan) in children referred to the ED 2015-03-21 anticipated 74 Complete https://irct.ir/trial/27338 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: The first participant in the study is randomly assigned to one of the groups based on randomization table (Appendix 2 below), and the next patient will be assigned so. 15 min before the procedure, children in intranasal midazolam group (0.2 mg / kg) and 30 minutes before the procedure, patients in oral midasolam group ( 0.5 mg / kg) receive the drug , then If the target sedation was done , the child will be transferred to a diagnostic radiologic procedure (CT scan, radiology, and ultrasound). After completing the diagnostic action, the data sheet is completed and the patient's vital signs are again checked. If the child was in good condition he or she undergo other diagnostic or therapeutic process. if unstable, the child will be resuscitated. finally the care sheet will be delivered to parents, Blinding description: The first participant in the study is randomly assigned to one of the groups based on randomization table (Appendix 2 below), and the next patient will be assigned so.And no one Knows anything about allocation. 3 Pediatrics Sedation. The first participant in the study is randomly assigned to one of the groups based on randomization table (Appendix 2 below), and the next patient will be assigned so.And no one Knows anything about allocation.. 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 Dr. Massoud mayel
Emergency Medicine Department - Shahid Bahonar Hospital - Kerman - IRAN
Kerman Iran (Islamic Republic of) 7613747181 +98 34 3223 5011 masoud.mayel@gmail.co Kerman University of Medical Sciences scientific Dr. Massoud mayel
National Garden Square. Qarani Street
کرمان Iran (Islamic Republic of) 7613747181 00+98 34 3223 5011 masoud.mayel@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) age 2 to 12 years old mild to moderate traumatic brain injury no concomitant nasal trauma or nasal anatomic abnormality 2 years 12 years Both 1. Parental dissatisfaction GCS≤8 Unstable hemodynamic Treatment - Drugs The first participant in the study is randomly assigned to one of the groups based on randomization table (Appendix 2 below), and the next patient will be assigned so.And no one Knows anything about allocation. Sedation Level. Timepoint: 15 minutes after intranasal method and 30 minutes after oral method. Method of measurement: Nialc Wilton Method. Parent's level of satisfaction from procedure. Timepoint: After completing procedure. Method of measurement: Questionnare. Kerman University of Medical Sciences Approved 2017-07-23 Kerman University of Medical Sciences Somayeh Cross road - Research Center - Kerman University of Medical Sciences Kerman Kerman Iran (Islamic Republic of)