Pediatric trauma. Injury nonspecified
Conditions
Interventions
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 aft
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 inj
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
Sponsors
Shahid Sadoughi University of Medical Sciences
Eligibility
Sex/Gender
All
Age
1 Years to 6 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMajid Hajimaghsoudi
Shahid Sadoughi University of Medical Scienses
Outcome results
None listed