This study is a parallel single-blind randomized clinical trial comparing sedative effect of Midazolam injected by jet injector, with intravenous Midazolam for procedural sedation in children, 1 to 6 years old, presenting to the Emergency Department due to trauma. Patients eligible for the study, according to inclusion and exclusion criteria, are randomly allocated to two (30 person) groups after informed consent. Before the diagnostic procedure Midazolam is administered subcutaneously with the jet injector in the first group and intravenously through a peripheral catheter in the second group. Children are monitored for vital signs and level of consciousness before and during the sedation. When the patient reach the level 1 of sedation, the procedure is started. If the patient doesn't inter to the sedation phase, in the first group injection is repeated 20 min after the first injection and in the second group the administered dose is repeated every 3 min to reach the sedative effect or the maximum dose. Patient is monitored until he become alert and the time is recorded. Emergency department stay time is measured from the admission and discharge time and recorded. Eventually the parents and caring physician satisfaction from the procedure is evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201510018640N2
Registration date:2016-03-23, 1395/01/04
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-03-23, 1395/01/04
Registrant information
Name
Majid Hajimaghsoudi
Name of organization / entity
Shahid Sadoughi University of Medical Scienses
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2719
Email address
hajimaghsoudi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
no funding source
Expected recruitment start date
2016-05-04, 1395/02/15
Expected recruitment end date
2016-07-04, 1395/04/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing sedative effect of Midazolam injection by jet injector with intravenous Midazolam for diagnostic procedures in 1 to 6 years old children
Public title
Efficacy of Midazolam on sedation
Purpose
Treatment
Inclusion/Exclusion 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.
Age
From 1 year old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Sadoughi University of Medical Scienses
Street address
Shahid Sadoughi University of Medical Scienses Central Organizatio, Shahid Doctor Bahonar Square, Yazd
Time interval between admission and discharge from the emergency department
2
Description
Time to appropriate sedation
Timepoint
After the intervention
Method of measurement
Time interval between drug administration to level one of sedation
3
Description
Time to complete arrosal
Timepoint
After the intervention
Method of measurement
Time interval between drug administration to complete arrosal
4
Description
Failure of sedation
Timepoint
After the intervention
Method of measurement
Not reaching to the level one of sedation after administrating the maximum determined dose
5
Description
Physician satisfaction from sedation
Timepoint
After the intervention
Method of measurement
Five choice likert scale
6
Description
Parents satisfaction from sedation
Timepoint
After the intervention
Method of measurement
Five point likert scale
7
Description
Rate of complications
Timepoint
After the intervention
Method of measurement
Assessment of sign and symptoms of sedation complication
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.