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IRCT20250420065398N1 IRCT 2026-05-07 Shahid Beheshti University of Medical Sciences Comparison of Dexmedetomidine and Midazolam in Children Undergoing Abdominal Mass Surgery Comparison of the Effects of Dexmedetomidine and Midazolam on Postoperative Pain and Agitation in Pediatric Patients Undergoing Abdominal Mass Surgery 2024-12-21 anticipated 60 Recruiting https://irct.ir/trial/88220 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible patients will be randomly assigned to one of the two groups receiving dexmedetomidine or midazolam. Randomization will be performed using a simple randomization method and by means of a computer‑based random number table. The random allocation sequence will be performed using SPSS software. Group allocation will be concealed by sealed, opaque, and sequentially serial‑numbered envelopes that have been prepared by an individual independent of the study implementation team, Blinding description: This study is designed as a double‑blind clinical trial.The study drugs will be prepared in equal volumes and administered intranasally by a nurse who is not involved in the evaluation of patients and data collection.The patients, their parents, clinical caregivers, and outcome assessors will be unaware of the group assignments throughout the study period. 3 Pediatric patients undergoing abdominal mass surgery. Intervention 1: Intervention group: Patients in this group, after induction of standard general anesthesia including the use of sevoflurane (MAC=8%) and nitrous oxide (60%), and after achieving adequate depth of anesthesia and placement of a venous line and intravenous injection of fentanyl 2 micrograms per kilogram and atracurium 0.5 milligrams per kilogram, and appropriate airway placement. Maintenance of anesthesia is performed using propofol. Before extubation, 4 µg/kg dexmedetomidine from the Exir pharmaceutical company is brought to a volume of 5 milliliters using 5% dextrose solution and, without specifying the composition of the solution, is handed over to the relevant nurse and administered intranasally to the patient. Intervention 2: Control group: Patients in this group, after induction of general anesthesia similar to the intervention group, midazolam 0.5 milligrams per kilogram from the Exir pharmaceutical company is brought to the same volume using dextrose solution and, without specifying the composition of the solution, is handed over to the relevant nurse and administered intranasally to the patient. 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 As this study is conducted as part of a postgraduate thesis, no final decision has been made regarding the sharing of individual participant data (IPD) at this stage. Any future decision will be made in accordance with ethical regulations and institutional policies.
public Seyed Mehdi Saadatmand
Shahid Beheshti University of Medical Sciences, Shahid Chamran Highway, Velenjak, Tehran, Iran
Tehran Iran (Islamic Republic of) 1985717443 +98 939 529 4299 Mahdi.saadatmand@gmail.com Shahid Beheshti University of Medical Sciences scientific Seyed Mehdi Saadatmand
Shahid Beheshti University of Medical Sciences, Shahid Chamran Highway, Velenjak, Tehran, Iran
Tehran Iran (Islamic Republic of) 1985717443 +98 939 529 4299 Mahdi.saadatmand@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Children aged more than 9 months Candidates for elective abdominal mass surgery American Society of Anesthesiologists physical status I or II Both male and female patients Written informed consent obtained from parents or legal guardians 9 months no limit Both Known allergy or hypersensitivity to dexmedetomidine or midazolam Presence of significant cardiac, respiratory, hepatic, or renal disease Use of sedative or analgesic drugs within 24 hours before surgery R45.1 Restlessness and agitation Treatment - Drugs Treatment - Drugs Intervention group: Patients in this group, after induction of standard general anesthesia including the use of sevoflurane (MAC=8%) and nitrous oxide (60%), and after achieving adequate depth of anesthesia and placement of a venous line and intravenous injection of fentanyl 2 micrograms per kilogram and atracurium 0.5 milligrams per kilogram, and appropriate airway placement. Maintenance of anesthesia is performed using propofol. Before extubation, 4 µg/kg dexmedetomidine from the Exir pharmaceutical company is brought to a volume of 5 milliliters using 5% dextrose solution and, without specifying the composition of the solution, is handed over to the relevant nurse and administered intranasally to the patient. Control group: Patients in this group, after induction of general anesthesia similar to the intervention group, midazolam 0.5 milligrams per kilogram from the Exir pharmaceutical company is brought to the same volume using dextrose solution and, without specifying the composition of the solution, is handed over to the relevant nurse and administered intranasally to the patient. Emergence agitation severity. Timepoint: At recovery room arrival and during the first 30 minutes after extubation. Method of measurement: Assessed using the Emergence Agitation Scale. Postoperative pain intensity. Timepoint: During the first 30 minutes after extubation. Method of measurement: Assessed using the Visual Analog Scale. Shahid Beheshti University of Medical Sciences Approved 2025-12-16 Research Ethics Committee of the School of Medicine, Shahid Beheshti University of Medical Sciences Sixth Floor, Number Two University Headquarters Building, Shahid Beheshti University of Medical Sciences and Health Services, Arabi Street, Yemen Street, Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)