Comparing the Effect of Different Doses of Fentanyl on Sedation of Infants with respiratory distress syndrome under Mechanical Ventilation; A Randomized Clinical Trial
This randomized clinical trial was conducted to compare the effect of two different doses of Fentanyl on sedation of 60 infants with respiratory distress syndrome 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 Fentanyl (0.5 mcg/kg) and the second group received 1 mcg/kg of Fentanyl during ventilation. Sedative effects of drugs were evaluated by respiratory rate, arterial oxygen saturation and concentration of required oxygen. Duration of hospitalization, required time of ventilation were recorded and compared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017082517413N27
Registration date:2017-11-17, 1396/08/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-11-17, 1396/08/26
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
2016-06-01, 1395/03/12
Expected recruitment end date
2017-03-05, 1395/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effect of Different Doses of Fentanyl on Sedation of Infants with respiratory distress syndrome under Mechanical Ventilation; A Randomized Clinical Trial
Public title
The effect of two different doses of Fentanyl on sedation of infants with respiratory distress syndrome under mechanical ventilation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Infants between 2.5 and 4 kg of weight with respiratory distress syndrome 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
Randomization was done using random number table.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Pharmaceutical Sciences Branch, Islamic Azad University
Street address
Yasaman alley, Yakhchal st. ,Tehran
City
Tehran
Postal code
Approval date
2015-09-09, 1394/06/18
Ethics committee reference number
IR.IAU.PS.REC.1395.28
Health conditions studied
1
Description of health condition studied
Respiratory distress syndrome of newborn
ICD-10 code
P22.0
ICD-10 code description
Respiratory distress syndrome of newborn
Primary outcomes
1
Description
Respiratory rate
Timepoint
before and one hour after intervention
Method of measurement
Respiration count in one minute by nurse
2
Description
Arterial Oxygen saturation
Timepoint
before and one hour after intervention
Method of measurement
Pulse Oxymetry
3
Description
Duration of hospitalization
Timepoint
Beginning of study to discharge
Method of measurement
Counting hospital stay days
4
Description
Duration of Ventilation
Timepoint
After Intervention
Method of measurement
Counting ventilator-dependent days
5
Description
Oxygen concentration
Timepoint
before and one hour after intervention
Method of measurement
Mechanical ventilation device
Secondary outcomes
1
Description
Pneumothorax
Timepoint
After Intervention
Method of measurement
Plain chest X-ray
Intervention groups
1
Description
First group: Fentanyl 0.5 mcg/kg as single dose
Category
Treatment - Drugs
2
Description
Second group: Fentanyl 1 mcg/kg as single dose
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Najmiyeh Hospital
Full name of responsible person
Bita Najafian
Street address
Hafez, Jomhouri st., Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Baqiyatallah University of Medical Sciences
Full name of responsible person
Morteza Izadi
Street address
Baqiyatallah University of Medical Sciences, Nosrati Alley, Sheykh Bahaei st., Mollasadra st., Vanaq sq.,
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Baqiyatallah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Student Research Committee, Baqiyatallah University of Medical Sciences, Tehran, Iran