Comparison of the Effect of Atropine Alone and in Combination with Midazolam on the Prevention of Pain of Endotracheal Intubation in Premature Neonates with Respiratory Distress
Comparison of the effect of Atropine alone and in combination with Midazolam on mean of pain score of endotracheal intubation in premature neonates with respiratory distress.
Design
This study is a two arm parallel group double blinded phase 2 clinical trail.
During the study period 105 newborn infants were included and eventually 80 newborns were evaluated which divided in to case and control group equally
Settings and conduct
This study was doneon premature patients who admitted to the NICU ward at Alzahra and ShahidBeheshti University hospitals, Isfahan, Iran.If patient meet the eligible critria divided to Two group according to the odd or even numbers of document and recieved the drug package A or B and record the degree of pain and changes of vital sign before and after intubation
Participants/Inclusion and exclusion criteria
Patients were newborns with gestational age of less than 37 weeks who had respiratory distress syndrome and needed nasal continuous positive airway pressure with a fraction of inspiration oxygen of at least 40% to maintain oxygen saturation between 90 to95% and were candidates for intubation,surfactant and rapid extubation. Enrolled patients with maxillofacial anomalies, congenital heart diseases or previous intubation were not included in the study. Patients who underwent 2 or more failed attempts for intubation were excluded from the study
Intervention groups
In intervention group neonates receive Midazolam with Atropine five minute before intubation and in control group neonates receive Atropine five minute before intubation
Main outcome variables
Pain Score; Heart Rate; Arterial Blood Pressure; Arterial Oxygen Saturation Percent; Number of Attempts for Intubation and Duration of Intubation.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130329012869N2
Registration date:2020-06-09, 1399/03/20
Registration timing:registered_while_recruiting
Last update:2020-06-09, 1399/03/20
Update count:0
Registration date
2020-06-09, 1399/03/20
Registrant information
Name
zohreh badiee
Name of organization / entity
Isfahan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1668 5555
Email address
badiei@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-02, 1398/04/11
Expected recruitment end date
2020-07-01, 1399/04/11
Actual recruitment start date
2019-07-02, 1398/04/11
Actual recruitment end date
2020-07-01, 1399/04/11
Trial completion date
2020-07-01, 1399/04/11
Scientific title
Comparison of the Effect of Atropine Alone and in Combination with Midazolam on the Prevention of Pain of Endotracheal Intubation in Premature Neonates with Respiratory Distress
Public title
Premedication with Intravenous Midazolam for Neonatal Endotracheal Intubation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age of less than 37 weeks
Presence of respiratory distress syndrome and the need for nasal continuous positive airway pressure (Nasal CPAP)with a fraction of inspired oxygen (Fio2)of at least 40% to maintain arterial oxygen saturation between 90 to95%
To be a candidate for surfactant treatment with Intubation Surfactant Rapid Extubation ( INSURE) method
Exclusion criteria:
Maxillofacial anomalies, congenital heart diseases
Previous endotracheal intubation
Twice or more failed attempts for intubation
Age
From 1 day old to 30 days old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
105
Actual sample size reached:
80
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Midazolam with atropine and atropine alone are put in different packages called A and B by some one who dose not involve in this study
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
research ethics committee of Isfahan University of Medical
Street address
No 26- Laleh Ave- Boozarjomehr Blvd- 2nd Moshtagh - Esfahan city
City
Esfahan
Province
Isfehan
Postal code
8158857171
Approval date
2016-06-06, 1395/03/17
Ethics committee reference number
Ir.mui.rec.1395.3.018
Health conditions studied
1
Description of health condition studied
pain during endotracheal intubation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain Score
Timepoint
Before intervention and immediatly after intubation
Method of measurement
Premature Infant Pain Profile (PIPP)
Secondary outcomes
1
Description
Heart Rate
Timepoint
At the beginning of the study; before drug injection; immediately after intubation and 10 minutes after intubation.
Method of measurement
Observation and pulse oxymeter
2
Description
Arterial Blood Pressure
Timepoint
At the beginning of the study; before drug injection; immediately after intubation and 10 minutes after intubation.
Method of measurement
Observation and pulse oxymeter
3
Description
Arterial Oxygen Saturation Percent
Timepoint
At the beginning of the study; before drug injection; immediately after intubation and 10 minutes after intubation.
Method of measurement
Observation and pulse oxymeter
4
Description
Number of Attempts for Intubation
Timepoint
During the intubation
Method of measurement
Observation
5
Description
Duration of Intubation
Timepoint
During the intubation
Method of measurement
Timer
Intervention groups
1
Description
Intervention group:Injection of 150 microgram per kilogram midazolam intravenously in 5 minute and injection of 10 microgram per kilogram atropine intravenously 5 minute perior to intubation
Category
Prevention
2
Description
Control group: injection of 10 microgram per kilogram atropine intravenously 5 minute perior to intubation
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra University Hospital
Full name of responsible person
Zohreh Badiee
Street address
Hezar jarib Ave - Esfahan city
City
Esfahan
Province
Isfehan
Postal code
8158857171
Phone
+98 31 3267 4572
Email
badiei@med.mui.ac.ir
2
Recruitment center
Name of recruitment center
Beheshti Univercity Hospital
Full name of responsible person
Zohreh Badiee
Street address
Hezar jarib Ave - Esfahan city
City
Esfahan
Province
Isfehan
Postal code
8158857171
Phone
+98 31 3267 4572
Email
badiei@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Vice chancellor of research of medicine univercity of esfahan
Street address
Hezar jarib Ave - Esfahan
City
Esfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3793 2288
Email
Research@mui.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zohreh Badiee
Position
professor of pediatrics
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
No 18-Bahar Ave - 2nd Moshtagh- Esfahan city
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 4572
Email
badiee@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zohreh Badiee
Position
professor of pediatrics
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
No 18,Bahar Ave, 2 nd Moshtagh, Esfahan city
City
Esfahan
Province
Isfehan
Postal code
815887171
Phone
+98 31 3267 4572
Email
badiei@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zohreh Badiee
Position
professor of pediatrics
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
No 18,Bahar Ave,2 nd Moshtagh, isfahan
City
Esfahan
Province
Isfehan
Postal code
8158857171
Phone
+98 31 3267 4572
Email
badiei@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Those information that related to main consequence is shareable
When the data will become available and for how long
after publication
To whom data/document is available
Employed researchers in univercity institutes
Under which criteria data/document could be used
Increasing knowledge of pediatricians and neonatologists
Increasing the quality of health service
Spreading the consumption of premedication
From where data/document is obtainable
Send a massage to Badiei@med.mui.ac.ir
WWW.journalonweb.com/jrms
Send amassage to Dr.hamed zandi :Zandi 878@gmail.com
What processes are involved for a request to access data/document
Massaging with notice the Email address and title of research to the magazine office or one of the researchers then identify confirmation of applicant baseed on their documents and finally reply those data file considered that it will be take less than a week.