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IRCT201510018640N2 IRCT 2016-03-23 Shahid Sadoughi University of Medical Sciences Efficacy of Midazolam on sedation Comparing sedative effect of Midazolam injection by jet injector with intravenous Midazolam for diagnostic procedures in 1 to 6 years old children 2016-05-04 anticipated 30 Complete https://irct.ir/trial/9132 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Pediatric trauma. Intervention 1: In the intervention group Midazolam is administered 0.2 mg/kg subcutaneously with the jet injector. If the patient doesn't inter to the sedation phase, injection is repeated 20 min after the first injection. Intervention 2: In the control group Midazolam is administered 0.1 mg/kg intravenously through a peripheral catheter. If the patient doesn't inter to the sedation phase, the administered dose is repeated every 3 min to reach the sedative effect or the maximum (0.6 mg/kg) dose.
public Majid Hajimaghsoudi
Shahid Doctor Rahnemoon Hospital, Farrokhi Street, Yazd
Yazd Iran (Islamic Republic of) 8913893111 +98 35 3626 0000 hajimaghsoudi@gmail.com Shahid Sadoughi University of Medical Scienses scientific Majid Hajimaghsoudi
Shahid Rahnemoon Hospital, Farrokhi Street, Yazd
Yazd Iran (Islamic Republic of) 8913893111 +98 35 3626 0000 hajimaghsoudi@gmail.com Shahid Sadoughi University of Medical Scienses Iran (Islamic Republic of) Iran (Islamic Republic of) Children 1-6 years old coming to Emergency Department due to trauma, requiring sedation for diagnostic procedures are included in the study. Those patients with one or more of the fallowing conditions are excluded: Unstable vital signs; Decreased level of consciousness; Anticonvulsants drug use; Hypersensitivity to Midazolam; Reluctance to participate in the study; Patients with moderate to severe (distracting) pain. 1 year 6 years Both T14.9 Injury nonspecified Treatment - Drugs Treatment - Drugs In the intervention group Midazolam is administered 0.2 mg/kg subcutaneously with the jet injector. If the patient doesn't inter to the sedation phase, injection is repeated 20 min after the first injection. In the control group Midazolam is administered 0.1 mg/kg intravenously through a peripheral catheter. If the patient doesn't inter to the sedation phase, the administered dose is repeated every 3 min to reach the sedative effect or the maximum (0.6 mg/kg) dose. Success rate of sedation for prosedure. Timepoint: Emediately after the procedure. Method of measurement: Sedation scale (level 0: conscious- level 1: silence- level 2: drowsiness- level 3: snoozing- level 4: deep sleep). Emergency department stay time. Timepoint: Before and after the intervention. Method of measurement: Time interval between admission and discharge from the emergency department. Time to appropriate sedation. Timepoint: After the intervention. Method of measurement: Time interval between drug administration to level one of sedation. Time to complete arrosal. Timepoint: After the intervention. Method of measurement: Time interval between drug administration to complete arrosal. Failure of sedation. Timepoint: After the intervention. Method of measurement: Not reaching to the level one of sedation after administrating the maximum determined dose. Physician satisfaction from sedation. Timepoint: After the intervention. Method of measurement: Five choice likert scale. Parents satisfaction from sedation. Timepoint: After the intervention. Method of measurement: Five point likert scale. Rate of complications. Timepoint: After the intervention. Method of measurement: Assessment of sign and symptoms of sedation complication. Shahid Sadoughi University of Medical Sciences Approved 2010-09-23 Shahid Sadoughi University of Medical Scienses Shahid Sadoughi University of Medical Scienses Central Organizatio, Shahid Doctor Bahonar Square, Yazd Yazd Iran (Islamic Republic of)