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IRCT20250722066589N1 IRCT 2025-07-31 Shahid Beheshti University of Medical Sciences The effect of dexmedetomidine and ketamine on core body temperature changes in children under sedation during MRI The effect of dexmedetomidine and ketamine on core body temperature changes in children under sedation during MRI 2025-08-23 anticipated 60 Complete https://irct.ir/trial/84978 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients will be assigned to two groups using a sealed envelope method: Group I (Dexmedetomidine group) and Group II (Ketamine group), Blinding description: Patients will be assigned to two groups using a sealed envelope method: Group I (Dexmedetomidine group) and Group II (Ketamine group). Upon enrollment, the envelope will be opened to determine the allocated drug, without the care provider being aware of the drug identity. Based on this allocation, the care provider will administer the medication, and patient data will be collected accordingly. In addition to the patient and the care provider, the data analyst will also be blinded to the type of intervention to ensure unbiased analysis of the results. 1-2 The effect of dexmedetomidine and ketamine on core body temperature changes in children under sedation during MRI. Intervention 1: Intervention group: Dexmedetomidine. Intervention 2: Control group: ketamine. Yes - There is a plan to make this available What will be shared: Data collection and analysis are fully shareable. When: Since data collection began in September 1404 To whom: Academic institutions Conditions: Changes to data are not allowed Where to obtain: Dr Malihe Abniki How to obtain: 3 -6 mon Comments:
public Malihe Abniki
Department of Anesthesiology , 4th Floor , shohada-y- tajrish Hospital Valiasr street
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2271 8000 dr.abniki@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Malihe Abniki
Department of Anesthesiology , 4th Floor , shohada-y- tajrish Hospital Valiasr street
Tehran Iran (Islamic Republic of) 1989934148 +98 21 25719 dr.abniki@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Children aged 6 months to 10 years with ASA class I–II undergoing MRI under anesthesia at Mofid Hospital in the year 1404 (2025) 6 months 10 years Both Allergy to intravenous anesthetics severe cardiac disease severe pulmonary disease increased intracranial pressure epilepsy initial body temperature of 37.5°C or higher signs of dehydration in the patient Prevention Prevention Intervention group: Dexmedetomidine Control group: ketamine The effect of dexmedetomidine and ketamine on body temperature changes in children under anesthesia during MRI imaging based on demographic variables. Timepoint: Before and after MRI. Method of measurement: Thermometer. Shahid Beheshti University of Medical Sciences Approved 2025-07-21 Ethics committee of Shahid Beheshti University of Medical Sciences Building No. 2 , Fifth Floor, Shahid Arabi Street , Yemen Street, Shahid Chamran Highway, Tehran - Tehran Tehran Iran (Islamic Republic of)