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IRCT20190509043538N1 IRCT 2019-08-26 Esfahan University of Medical Sciences Comparison of the sedative effect of intranasal midazolam and dexmedetomidine for pediatric Comparison the sedative effect of intranasal midazolam and dexmedetomidine with for sedation of children1 to 6 year-old undergoing Computerized tomography(CT) scan that referred to emergency department of Kashani and Al-zahra hospitals in Isfahan in 2017 2017-10-23 anticipated 162 Complete https://irct.ir/trial/40754 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Other, Randomization description: The studied samples will be randomly divided into two groups of 81 individuals by selecting envelopes. Each envelope was contained with one of the two labels A or B representing Midazolam or Dexmedetomidine. Children will be in one of two groups , Blinding description: To meet the double blindness of the study, Midazolam ( dose of 0.3 mg /kg) and Dexmedetomidine (dose of 3 mcg /kg) will be prepared daily by the emergency nurse (uninformed) and labeled A or B and also will be available for the researcher daily. The researcher will be prescribed the mentioned medicine by syringe intranasally. 3 Head trauma. Intervention 1: Intervention group: The intervention group will have received Dexmedetomidine (manufactured by Hospira Co. USA) interanasally. The agent will be prepared daily by a nurse and will prescribed by Intranasal Mucosal Atomization Device (IMAD), that called MAD Nasal 300 (manufactured by Teleflex Medical Co, USA) by dose 3 μg/kg. Up to 1 ml of the medication will be injected in each nostril of nose by a 2 cc syringe (G 22, manufactured by Avapezeshk Co, Iran). The injection of medication is carried out when the patient is being supine position and in resting. Two minutes after injection of medication into the nostrils, the patient can place in sitting position. Intervention 2: Control group: The control group will have received Midazolam (manufactured by Exir Co, Iran) interanasally. The agent will be prepared daily by a nurse and will prescribed by Intranasal Mucosal Atomization Device (IMAD), that called MAD Nasal 300 (manufactured by Teleflex Medical Co, USA) by dose 0.3 μg/kg. Up to 1 ml of the medication will be injected in each nostril of nose by a 2 cc syringe (G 22, manufactured by Avapezeshk Co, Iran). The injection of medication is carried out when the patient is being supine position and in resting. Two minutes after injection of medication into the nostrils, the patient can place in sitting position. 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 If there are no legal and ethical issues, it will be released
public Azizkhani ,Reza
Sufeh Blvd, Al Zahra Hospital, Department of Emergency Medicine
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 r_azizkhani@med.mui.ac.ir Esfahan University of Medical Sciences scientific Azizkhani ,Reza
Sufeh Blvd, Al Zahra Hospital, Department of Emergency Medicine
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 r_azizkhani@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Children's age range from 1 year to 6 years old requires a CT scan. Parental satisfaction to participate in this study. 1 year 6 years Both Having excessive sensitivity to benzodiazepines and family members as well as alpha agonists Alertness level based on the Glasgow Coma Score less than 15 Having very low blood pressure or shock Having weak and unstable vital signs Having lung disease Treatment - Drugs Treatment - Drugs Intervention group: The intervention group will have received Dexmedetomidine (manufactured by Hospira Co. USA) interanasally. The agent will be prepared daily by a nurse and will prescribed by Intranasal Mucosal Atomization Device (IMAD), that called MAD Nasal 300 (manufactured by Teleflex Medical Co, USA) by dose 3 μg/kg. Up to 1 ml of the medication will be injected in each nostril of nose by a 2 cc syringe (G 22, manufactured by Avapezeshk Co, Iran). The injection of medication is carried out when the patient is being supine position and in resting. Two minutes after injection of medication into the nostrils, the patient can place in sitting position. Control group: The control group will have received Midazolam (manufactured by Exir Co, Iran) interanasally. The agent will be prepared daily by a nurse and will prescribed by Intranasal Mucosal Atomization Device (IMAD), that called MAD Nasal 300 (manufactured by Teleflex Medical Co, USA) by dose 0.3 μg/kg. Up to 1 ml of the medication will be injected in each nostril of nose by a 2 cc syringe (G 22, manufactured by Avapezeshk Co, Iran). The injection of medication is carried out when the patient is being supine position and in resting. Two minutes after injection of medication into the nostrils, the patient can place in sitting position. Success in sedation intranasally. Timepoint: 0,10,20,30 min. Method of measurement: By Ramsay scoring. Measurement of blood pressure ; pulse rate; blood oxygen saturation;. Timepoint: 0;10;20;30 minutes. Method of measurement: PulseOxymetery;Sphygmomanometer. Esfahan University of Medical Sciences Approved 2017-04-21 Ethics committee of Isfahan University of Medical Science No.15,Yas building, Sadoughi Ave,Yasaman St, Qom Isfehan Iran (Islamic Republic of)