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IRCT20230520058235N1 IRCT 2023-07-23 Shahid Beheshti University of Medical Sciences Effect of Dexmedomidine in pediatric anesthesia The effect of low dose Dexmedetomidine in reducing the dose of analgesic and sedative medications in the pediatric intensive care unit 2023-08-23 anticipated 60 Complete https://irct.ir/trial/70252 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization has been performed using the block randomization table. The block randomization method is designed to randomize subjects into ten blocks consisting of six and four patients resulting in two equally divided groups. This method is used to ensure a balance in sample size across groups over time. Randomization was centralized and computerized with a concealed randomization sequence carried out at https://www.sealedenvelope.com/. In this method, a randomization list with unique codes for each patient is generated. Patients will enroll in the study based on the randomization list into medication or placebo groups with a unique code for follow-up. The allocation person will inform the investigators of the patient codes from the list by phone for randomization and blinding, Blinding description: The drug and placebo will be in coded same packages; a designated person will provide the codes from block randomization via phone. The same person will group the data at the end of the trial, and the expert will perform statistical analysis and after results, the pocket that is with the placebo provider would be opened, and the data will be decrypted. The data regarding harm and benefits of treatment will be provided to the patient and caregiver. 3 Opioid related disorders in pediatric intensive care unit. Intervention 1: Intervention group:In this group, patients will be anesthetized with 0.1 milligram per kilogram of intravenous Midazolam and 1 (or more) micrograms per kilogram of Fentanyl along with 0.2 micrograms per kilogram per hour of Dexmedomidine. Intervention 2: Control group: In this group, they will be anesthetized with 0.1 milligram of intravenous Midazolam per kilogram and 1 (or more) micrograms of Fentanyl per kilogram. Yes - There is a plan to make this available What will be shared: The main outcome will be available. When: Six months after publishing data. To whom: The data will be available per request for people working in academic institutions. Conditions: The data will available for using in systematic review and meta-analysis. Where to obtain: The data will be available by contacting email; mirrahimi@sbmu.ac.ir. How to obtain: The data will available for using in systematic review and meta-analysis. Comments:
public Najmeh Forouzan
School of Pharmacy, Shahid Beheshti University of Medical Sciences, Niayesh Highway, Valiasr Ave, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2222 7020 najmeh.star@ymail.com Shahid Beheshti University of Medical Sciences scientific Dr. Bahador Mirrahimi
Mofid children's Hospital, Miradmad Junction, Shariaty Ave.
Tehran Iran (Islamic Republic of) 1991953381 +98 21 2222 7020 mirrahimi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age 1 year to 12 years Admission to pediatric intensive care unit (PICU) Under mechanical ventilation and sedation 1 year 12 years Both Children receiving Barbiturates Persistent bradycardia (less than 5th percentile of normal for age) Hypotension (less than 5th percentile of normal age) Cardiac arrhythmia Involvement of the central nervous system (brain trauma, encephalitis, meningitis...) F11 Opioid related disorders Treatment - Drugs Treatment - Drugs Intervention group:In this group, patients will be anesthetized with 0.1 milligram per kilogram of intravenous Midazolam and 1 (or more) micrograms per kilogram of Fentanyl along with 0.2 micrograms per kilogram per hour of Dexmedomidine. Control group: In this group, they will be anesthetized with 0.1 milligram of intravenous Midazolam per kilogram and 1 (or more) micrograms of Fentanyl per kilogram. Determining and comparing the needed total Fentanyl dose in each group. Timepoint: From enrollment up to seven days. Method of measurement: Dose counting. Determining and comparing the needed total Midazolam dose in each group. Timepoint: From enrollment up to seven days. Method of measurement: Dose counting. Determining the need for a second sedative drug in each group. Timepoint: From enrollment up to seven days. Method of measurement: Patient file. Determining the need for the third sedative drug in each group. Timepoint: From enrollment up to seven days. Method of measurement: Patient file. Determining the need for the muscle relaxant in each group. Timepoint: From enrollment up to seven days. Method of measurement: Patient file. Shahid Beheshti University of Medical Sciences Approved 2023-06-20 Research Ethics Committees of School of Pharmacy and Nursing & Midwifery- Shahid Beheshti University 2nd floor, School of Nursing and Midwifery, Valiasr and Niayesh junction Tehran Tehran Iran (Islamic Republic of)