The aim of this study is comparison the effectiveness of remifentanil versus fentanyl in pain control during elective endothracheal intubation for surfactant administration in preterm infants.Preterm newborns with gestational age between 28 weeks to 34 weeks and 6 days from last menstrual period and have respiratory distress according to clinical evaluation,after receiving consent of parents will be divided in two groups by random sampling.Neonates in group 1, receive 2 microgram per kilogram intravenous fentanyl infusion and neonates in group 2, receive 1 microgram per kilogram of the drug.In both groups drug Infusion will be start 1 minute before intubation, and drug infusion time in both groups will be 2 minutes. In each group, we will take a film before, during and after procedures of the intubation with a camera.The vital signs consist of heart rate, oxygen saturation and change in facial grimace will be documented in not named PIPP-R(Premature Infant Pain Profile-Revised) scoring sheet for each infant prior, during and after drug administration. All films and data will be interpreted and scored by one NIDCAP (Newborn Individualized Developmental Care and Assessment Program)-trained attending professor, who is blind about the type of the drug used in infant.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201310164113N7
Registration date:2017-05-07, 1396/02/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-07, 1396/02/17
Registrant information
Name
Mohammad Bagher Hosseini
Name of organization / entity
Tabriz Universisty of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
hossainm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Tabriz University of of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2017-05-10, 1396/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Remifentanil versus Fentanyl for pain control during elective endotracheal intubation for surfactant administration in preterm neonates
Public title
Remifentanil versus Fentanyl for pain control during elective endotracheal intubation in preterm neonates
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Preterm newborns with gestational age between 28 to 34 weeks and 6 days from last menstrual period of mother who was born in Alzahra teaching hospital of Tabriz; clinical criteria of respiratory distress (consists of: tachypnea, grunting, inter coastal retraction and increased oxygen requirement) and radio graphic findings of Respiratory Distress Syndrome; need for surfactant treatment by INSURE (Intubate, Surfactant, Extubate) procedure.
Exclusion criteria: other causes of respiratory distress in newborns; second or third degree AV heart block; use of fentanyl during 4 hours from delivery; severe asphyxia (APGAR score under 5 at 5th minutes after delivery ); impaired consciousness level; major congenital anomalies; difficult intubation due to facial anomalies; more than three attempts for intubation.
Age
From 1 day old to 3 days old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ٍٍEthics in Research Commitee of Tabriz medical university
Street address
Tabriz University of Medical Sciences , Golgasht avenue
Chang in heart rate, pulesxymetery amd blood pressure
Timepoint
Before, during and after endotracheal intubation
Method of measurement
Manitoring by automatic monitor and record of blood pressure by appropriate cuff
3
Description
Number attempts for a successful intubation
Timepoint
During endotracheal intubaion
Method of measurement
Observation
4
Description
Apnea ( stoping of respiration more than 20 seconds )
Timepoint
During intubation prosedures
Method of measurement
Observation and recording
5
Description
Sever hypoxia ( O2 saturaion<70%)
Timepoint
During and after endotracheal intubation
Method of measurement
Manitoring by automatic monitor
6
Description
Chest rigidity
Timepoint
During and after endotracheal Intubation
Method of measurement
Observation and recording
7
Description
Need for use of Naloxan
Timepoint
After endotracheal intubation
Method of measurement
Observation and recording
8
Description
Intraventricular hemorrage grade 2 and more
Timepoint
Day 3
Method of measurement
Ultrasonography with portable Sonoraphy device
Intervention groups
1
Description
Neonates in group1, one minute before intubation recieve 2 microgram per kilogram slow intravenous Fentanyl (manufactured by Abureyhan company)infusion in 2 minutes.
Category
Treatment - Drugs
2
Description
Neonates in group 2, one minute before intubation recieve 1 microgram per kilogram slow intravenous Remifentanil (manufactured by Mylan company) infusion in 2 minutes.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Teaching Hospital of Tabriz
Full name of responsible person
Mohammadbagher Hosseini
Street address
Artesh Avenue
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Tabriz University of of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Tabriz University of Medical Sciences , Golgasht avenue,No 2 Central Building,third floor
City
Tabriz
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 of Tabriz University of 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
Tabriz University of Medical Sciences
Full name of responsible person
Mohammadbagher Hosseini MD
Position
Associate Professor of Neonatology
Other areas of specialty/work
Street address
Neonatal Unit, Building 2, Alzahra Teaching Hospital, Artesh Ave
City
Tabriz
Postal code
5165933833
Phone
+98 41 3553 9161
Fax
Email
Hosseini.neo@gmail.com; hossainm@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Bagher Hosseini MD
Position
Associate Professor of neonatology
Other areas of specialty/work
Street address
Neonatal Unit, Building 2, Alzahra Teaching Hospital
City
Tabriz
Postal code
5138663134
Phone
+98 41 3553 9161
Fax
+98 41355566449
Email
hosseini.neo@gmail.com; hossainm@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Bagher Hosseini MD
Position
Associate Professor of Neonatology
Other areas of specialty/work
Street address
Neonatal Unit, Building 2, Artesh Ave, Alzahra Teaching Hospital
City
Tabriz
Postal code
5138663134
Phone
+98 41 3553 9161
Fax
+98 41 3556 6449
Email
hosseini.neo@gmail.com; hossainm@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)