]>
IRCT20221108056446N15 IRCT 2025-02-09 Esfahan University of Medical Sciences Nasal dexmedetomidine and oral chloral hydrate on sedation in children A comparative study of the effect of nasal dexmedetomidine and oral chloral hydrate on sedation of children during MRI 2025-02-19 anticipated 70 Complete https://irct.ir/trial/81573 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: With the convenience sampling method, the referring individuals who are eligible for the study are randomly divided into two groups: case and control. In this study, the division of individuals is done using the four-way permutation block method. In this method, A represents the individual who receives the intervention and B represents the individual who is in the control group. Considering the four-way block, we give the AABB permutation code 0, the ABAB permutation code 1, ABBA code 2, BAAB code 3, BBAA code 4, and BABA codes 5 to 9. Then, using the random number table, we randomly select a starting point and then consider the numbers in rows or columns. Considering the order of the numbers in the table, we assign the corresponding permutation to each number we encounter. Finally, 70 people will be divided into two groups. 2 Sedation. Intervention 1: Intervention group: Chloral hydrate will be administered orally. Children in this group will receive 5% chloral hydrate syrup at a dose of 50-100 micrograms/kg orally 10 minutes before the procedure. In addition, for chloral hydrate, a dose of 50 micrograms/kg is initially given. If sedation is not sufficient, the dose will be 100 micrograms/kg. Intervention 2: Control group: Nasal dexmedetomidine will be administered. Children in this group will receive intranasal dexmedetomidine at a dose of 2-3 micrograms/kg 10 minutes before surgery. The prescribed dose is started at 2 micrograms/kg and if sedation is not sufficient, 1 microgram/kg is added. 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 "There is no further information."
public Mohamadreza Ghazavi
Imam Khomeini Street
Esfahan Iran (Islamic Republic of) 81951-63381 +98 31 3386 6266 ghazavi8147@gmail.com Esfahan University of Medical Sciences scientific Mohamadreza Ghazavi
Imam Khomeini Street
Esfahan Iran (Islamic Republic of) 81951-63381 +98 31 3386 6266 ghazavi8147@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Children who are candidates for MRI and require sedation for any reason. The child's parents must consent to participate in the study. 6 months 10 years Both Patients with a history of respiratory diseases Stomach ulcers or liver disease Treatment with drugs that interact with chloral hydrate or dexmedetomidine The presence of a specific underlying condition that affects the interpretation of goals such as duration of sedation Any previous allergic reaction to chloral hydrate or dexmedetomidine T88.52 Failed moderate sedation during procedure Behavior Behavior Intervention group: Chloral hydrate will be administered orally. Children in this group will receive 5% chloral hydrate syrup at a dose of 50-100 micrograms/kg orally 10 minutes before the procedure. In addition, for chloral hydrate, a dose of 50 micrograms/kg is initially given. If sedation is not sufficient, the dose will be 100 micrograms/kg. Control group: Nasal dexmedetomidine will be administered. Children in this group will receive intranasal dexmedetomidine at a dose of 2-3 micrograms/kg 10 minutes before surgery. The prescribed dose is started at 2 micrograms/kg and if sedation is not sufficient, 1 microgram/kg is added. Sedation. Timepoint: Patients were examined every 5 minutes and then every 10 minutes for up to an hour. Method of measurement: The AVPU scale is used to assess a child's level of alertness and sleepiness. Esfahan University of Medical Sciences Approved 2025-01-09 Esfahan University of Medical Sciences Hazar Jarib Street, Azadi Square Isfahan Isfehan Iran (Islamic Republic of)