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IRCT20230701058628N2 IRCT 2023-07-27 Mazandaran University of Medical Sciences Comparison of effectiveness of dexmedetomidine plus Midazolam and fentanyl plus Midazolam in placement of central venous catheter in PICU Comparison of effectiveness of dexmedetomidine plus Midazolam and fentanyl plus Midazolam in placement of central venous catheter in Pediatric Intensive Care Unit (PICU) 2023-03-21 anticipated 50 Complete https://irct.ir/trial/71340 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: After meeting the inclusion criteria for the study, randomization is done by simple randomization method with age block. Dexmedetomidine and fentanyl drugs are similarly prepared and coded in a 10 mL syringe by a pharmacist and provided to the researcher. The patient and the treatment team will not know the nature of the contents of the syringes, and the desired syringe will be delivered to the treatment team daily based on the initial group determined. Only at the end of the study or in case of a complication that requires therapeutic intervention and knowing the name of the drug, the drug code is decoded by the researcher and the name of the drug is provided to the doctor. Before assigning the individuals in groupa, the assigned group is not clear, Blinding description: The study will be conducted in a double-blind manner. Dexmedetomidine and fentanyl drugs are similarly prepared and coded in a 10 mL syringe by a pharmacist and kept in the refrigerator until use. The patient, the prescribing nurse and the doctor are not aware of the type of therapeutic combination used. Only at the end of the study or in case of a complication that requires therapeutic intervention and knowing the name of the drug, the drug code is decoded by the researcher and the name of the drug is provided to the doctor. 3 Condition 1: Viral infection. Condition 2: Acute lower respiratory infection. Condition 3: Virus infections of central nervous system. Condition 4: Immunodeficiency. Condition 5: Renal failure requiring dialysis or plasmaphresis. Intervention 1: Intervention group: In the intervention group, 1 μg/kg intravenous dexmedetomidine is prescribed for ten minutes along with 0.1 mg/kg injectable midazolam as a loading dose. Dexmedetomidine infusion continues at a rate of 1 μg/kg/hour. Intervention 2: Control group: The control group recieves the general protocol of the Pediatric Intensive Care Unit (PICU) of BuAli Hospital and for sedation, receives fentanyl at a dose of 1 μg/kg for 10 minutes along with midazolam at a dose of 0.1 mg/kg during the procedure. Fentanyl infusion continues at a rate of 1 μg/kg/h. Yes - There is a plan to make this available What will be shared: Contact Dr.Mohammad Reza Navaeifar. Email: dr.navaifar@gmail.com When: Informations will send within few days after the email To whom: People working in academic institutions Conditions: Contact Dr.Mohammad Reza Navaeifar. Email: dr.navaifar@gmail.com Where to obtain: Email How to obtain: Informations will send within few days after the email. Comments:
public Dr. Fahimeh Dianati
Pediatric Infectious Diseases Research Center, Buali Hospital, Pasdaran Boulevard, Sari, Iran
Sari Iran (Islamic Republic of) 4815838477 +98 11 3334 2334 pidrc@mazums.ac.ir Mazandaran University of Medical Sciences scientific Mohammad Reza Navaeifar
Pediatric Infectious Diseases Research Center, Buali Hospital, Pasdaran Boulevard, Sari, Iran
Sari Iran (Islamic Republic of) 4815838477 +98 11 3334 2334 m.navaeifar@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Children needing central venous catheter placement in the pediatric intensive care unit 1 month 18 years Both Presence of bradycardia or hypotension High blood pressure above the 99th percentile Apnea before the study The presence of cardiac conduction disorder in the electrocardiogram before drug administration Patients with American Society of Anaesthesiologists' physical status classification III or higher Known kidney or heart failure History of heart surgery Shock Receiving other anesthetics, sedatives, injectable painkillers B34 J22 A81 D84.9 P96.0 Viral infection of unspecified site Unspecified acute lower respiratory infection Atypical virus infections of central nervous system Immunodeficiency, unspecified Congenital renal failure Treatment - Drugs Treatment - Drugs Intervention group: In the intervention group, 1 μg/kg intravenous dexmedetomidine is prescribed for ten minutes along with 0.1 mg/kg injectable midazolam as a loading dose. Dexmedetomidine infusion continues at a rate of 1 μg/kg/hour. Control group: The control group recieves the general protocol of the Pediatric Intensive Care Unit (PICU) of BuAli Hospital and for sedation, receives fentanyl at a dose of 1 μg/kg for 10 minutes along with midazolam at a dose of 0.1 mg/kg during the procedure. Fentanyl infusion continues at a rate of 1 μg/kg/h. Ramsay Sedation Score equal to or more than 3. Timepoint: Every 5 minutes until 5 minutes after sedation. Method of measurement: Ramsay scale. Mean arterial blood pressure. Timepoint: Every 5 minutes until 5 minutes after sedation. Method of measurement: Blood pressure monitor. Blood oxygen saturation. Timepoint: Every 5 minutes until 5 minutes after sedation. Method of measurement: Palsoxymeter. Heart rate and respiratory rate. Timepoint: Every 5 minutes until 5 minutes after sedation. Method of measurement: تعداد در دقیقه. Mazandaran University of Medical Sciences Approved 2023-01-24 Ethics committee of Mazandaran University of Medical Sciences Pediatric Infectious Diseases Research Center, Buali Hospital, Pasdaran Boulevard, Sari, Iran Sari Mazandaran Iran (Islamic Republic of)