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IRCT20100621004224N39 IRCT 2026-05-12 Esfahan University of Medical Sciences Comparison of the Effect of Intranasal Dexmedetomidine and Midazolam on Child’s Sedation and Cooperation Evaluation and Comparison of the Effect of Intranasal Dexmedetomidine and Midazolam on Child’s Sedation and Cooperation During IV Cannulation Prior to Dental Anesthesia and Heart Rate Changes During Laryngoscopy: A Randomized Controlled Clinical Trial 2026-05-20 anticipated 60 Recruiting https://irct.ir/trial/89888 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization using the blocking method with blocks in sizes 6 and 9. For randomization, the site https://www.sealedenvelope.com is used. All codes are recorded on paper and stored in specific envelopes. Each of the generated codes is kept separately inside the envelope and the secretary gives one of these envelopes to the patient before the patient enters the doctor's room. Accordingly, the next patient code is not predictable. The doctor determines which treatments to perform based on the patient's code. Only the physician performing the intervention will be aware of the code assigned to the patient. After evaluating the outcome, based on the patient's name, the collected information will be linked to the assigned code. N/A Anxiety. Intervention 1: The first intervention group will receive intranasal dexmedetomidine (Exir Company, Iran) at a dose of 1.5 µg/kg body weight, administered 20 minutes before the induction of anesthesia. Intervention 2: The second intervention group will receive intranasal midazolam (Exir Company, Iran) at a dose of 0.2 mg/kg body weight, administered 20 minutes before the induction of anesthesia. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Nastaran Kaviani
Isfahan University of Medical Sciences, Faculty of Medicine, Hezar Jarib St..
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3071 n.kaviani@yahoo.com Esfahan University of Medical Sciences scientific Dr. Naser Kavizni
Isfahan University of Medical Sciences, Faculty of Medicine, Hezar Jarib St..
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3071 n.kaviani@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Informed Consent Healthy children 3–5 years of age Need for general anesthesia for dental treatments 3 years 5 years Both Having contraindications for general anesthesia and nasotracheal intubation on the day of procedure/surgery History of hypersensitivity to midazolam or dexmedetomidine Use of sedative or anxiolytic medications within 24 hours prior to the study Severe obesity or severe underweight F06.4 Anxiety disorder due to known physiological condition Treatment - Drugs Treatment - Drugs The first intervention group will receive intranasal dexmedetomidine (Exir Company, Iran) at a dose of 1.5 µg/kg body weight, administered 20 minutes before the induction of anesthesia. The second intervention group will receive intranasal midazolam (Exir Company, Iran) at a dose of 0.2 mg/kg body weight, administered 20 minutes before the induction of anesthesia Anxiety. Timepoint: The beginning of the study and the end of the study. Method of measurement: Base on Modified Yale Preoperative Anxiety Scale. Sedation during venipuncture. Timepoint: 20 minutes after drug administration, at the same time as venipuncture. Method of measurement: Base on University of Michigan Sedation Scale. Heartbeat. Timepoint: Before and after laryngoscopy. Method of measurement: Using monitoring. Esfahan University of Medical Sciences Approved 2026-04-27 Isfahan University of Medical Sciences, Ethics Committee of the Faculty of Medicine Isfahan University of Medical Sciences, Hezar Jarib St.. Isfahan Isfehan Iran (Islamic Republic of)