Comparrison of the effect of midazolam, fentanyl and their combination on the frequency of self-extubation among children admitted to the intensive care unit
In this study, we want to find out which combination of medical treatments has a better analgesic and hypnotic effect on children admitted to the pediatric intensive care unit. This is a randomized, open-label, single center study on two hundred children admitted to pediatric ICU. Randomization in this study will be done using random numbers table. Patients will be allocated to three groups. Patients who have difficult airway or who are hemodynamically unstable would be excluded from the study.
Interventions in this study include: Intervention group 1: Intravenous fentanyl alone at the dose of 1-3 mcg/kg/hour in order to keep the Ramsay score between 2 and 3 during the mechanical ventilation. Intervention group 2: this group receives Midazolam at the dose of 0.15 mg/kg/hour and intravenous fentanyl at the dose of 1-3 mcg/kg/hour in order to keep the Ramsay score between 2 and 3 during the mechanical ventilation. Control group: Intravenous Midazolam alone at the dose of 0.15 mg/kg/hour in order to keep the Ramsay score between 2 and 3 during the mechanical ventilation.
The number of times that a child removes the ventilation tube and the number of days that the child is under ventilation are recorded and compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201611159475N2
Registration date:2017-02-12, 1395/11/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-02-12, 1395/11/24
Registrant information
Name
Bahador Mirrahimi
Name of organization / entity
Shahid Beheshti University of Medical Sciences, Faculty of Pharmacy
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 0118
Email address
mirrahimi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Pediatric Pathology Research Center, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-10-01, 1394/07/09
Expected recruitment end date
2016-10-01, 1395/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparrison of the effect of midazolam, fentanyl and their combination on the frequency of self-extubation among children admitted to the intensive care unit
Public title
Comparison of the effect of midazolam, fentanyl, and combination of them on the frequency of self-extubation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
pediatric ICU patients who are under mechanical ventilation who have normal consciousness level.
Exclusion criteria:
difficult airway management defined as the airway with a structural abnormality including cleft palate and Pierre Robin syndrome; systemic disorders that affect intubation (Mucopolysaccharidosis); Mallampati score over 2; Patients with unstable hemodynamics.
Age
From 1 month old to 15 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
the randomization has been performed using random numbers table.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of medical sciences, Arabi Ave, Daneshjoo Blvd, Velenjak.
City
Tehran
Postal code
1985717434
Approval date
2015-10-16, 1394/07/24
Ethics committee reference number
IR.SBMU.RAM.REC.1394.253
Health conditions studied
1
Description of health condition studied
weaning from mechanical ventilation
ICD-10 code
Z51.8
ICD-10 code description
Other specified medical care
Primary outcomes
1
Description
Number of self extubation
Timepoint
during mechanical ventilation
Method of measurement
report
Secondary outcomes
1
Description
The number of days under mechanical ventilation
Timepoint
during hospitalization in intensive care unit
Method of measurement
report
Intervention groups
1
Description
Control group: Intravenous Midazolam alone at the dose of 0.15 mg/kg/hour in order to keep the Ramsay score between 2 and 3 during the mechanical ventilation.
Category
Treatment - Drugs
2
Description
Intervention group 1: Intravenous fentanyl alone at the dose of 1-3 mcg/kg/hour in order to keep the Ramsay score between 2 and 3 during the mechanical ventilation.
Category
Treatment - Drugs
3
Description
Intervention group 2: this group receives Midazolam at the dose of 0.15 mg/kg/hour and intravenous fentanyl at the dose of 1-3 mcg/kg/hour in order to keep the Ramsay score between 2 and 3 during the mechanical ventilation