This randomized clinical trial was conducted to compare the effect of Midazolam and Fentanyl on sedation of 60 infants between 2.5 and 4 kg of weight who needed mechanical ventilation . Patients lower than 2.5 kg and more than 4 kg, as well as those with congenital heart disease, brain anomalies and metabolic or chromosomal syndromes were excluded from the trial. patients were randomly allocated to two groups; the first group underwent sedation with Midazolam (0.1 mg/kg) and the second group received 0.5mcg/kg of Fentanyl during ventilation. Duration of hospitalization, required time of ventilation, drug complications and feeding intolerance were recorded and compared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017082417413N26
Registration date:2017-09-02, 1396/06/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-02, 1396/06/11
Registrant information
Name
Hamidreza Karimi-Sari
Name of organization / entity
Student Research Committee, Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8126 4354
Email address
hrkarimisari@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Baqiyatallah University of Medical Sciences
Expected recruitment start date
2016-07-01, 1395/04/11
Expected recruitment end date
2017-03-03, 1395/12/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Fentanyl and Midazolam on the Sedation of infants under mechanical ventilation; A Randomized Clinical Trial
Public title
Comparison of Midazolam and Fentanyl for sedation of infants under mechanical ventilation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infants between 2.5 and 4 kg of weight who needed intubation and mechanical ventilation
Exclusion criteria: Patients lower than 2.5 kg and more than 4 kg; congenital heart disease; brain anomalies; metabolic or chromosomal syndromes
Age
From 1 day old to 28 days old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Pharmaceutical Sciences Branch, Islamic Azad University