Our goal is to investigate impact of Clonidine on level of sedative agents usage in mechanically ventilated children in PICU
Design
This randomized, double-blind, placebo-controlled, parallel-group and single center study will be conducted in PICU of Mofid Children`s Hospital, Tehran, Iran. Hundred children randomly divided in two groups , Treatment ( No.1 ) and Control ( No.2 ) by main administrator .
Settings and conduct
Randomized, double-blind, placebo-controlled, parallel-group and single center in Mofid Children`s Hospital, Tehran. Medical team (doctor and nurse) are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria : Children aged from 31 days to 15 years requiring ventilation for at least 3 days in PICU .
Exclusion criteria : Renal and hepatic failure ; Gastrointestinal intolerance ; Severe neurological disorders ; Inotrope use ; Bradycardia and Hypotension .
Intervention groups
Participants will be randomized 1:1 to ( group 1) fixed dose 5 μg/kg Clonidine every 6 hours via NGT(Abidi Pharmaceutical, Iran) plus variable dose 0.5 -2 µg/kg/hr Fentanyl and 0.05- 0.1 mg/kg Midazolam ( titrated by Ramsay scale 2-3 ) or placebo (group 2) variable dose 0.5 - 2 µg/kg/hr Fentanyl and 0.05- 0.1 mg/kg Midazolam.( titrated by Ramsay scale 2-3 )
Main outcome variables
Sedation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170920036296N1
Registration date:2017-12-29, 1396/10/08
Registration timing:registered_while_recruiting
Last update:2017-12-29, 1396/10/08
Update count:0
Registration date
2017-12-29, 1396/10/08
Registrant information
Name
Raha Khosravi
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 22278206
Email address
drrahakhosravi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Pediatric pathology research center
Expected recruitment start date
2017-07-01, 1396/04/10
Expected recruitment end date
2017-12-31, 1396/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of oral Clonidine on consumption of sedative agents in mechanically ventilated patients in pediatric intensive care unit
Public title
Impact of Clonidine on children sedation in PICU
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with age of 31 days to 15 years requiring mechanical ventilation for 3 days.
Exclusion criteria:
Age
From 31 days old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Double blind
Patient and medical team are blinded. Only one of research team is not blinded and is in charge of data collection.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Behesti University of Meidcal Sciences
Street address
Evin
City
Tehran
Province
Tehran
Postal code
1546815514
Approval date
2017-07-13, 1396/04/22
Ethics committee reference number
IR-SBMU.RETECH.REC.1396.347
Health conditions studied
1
Description of health condition studied
Sedation in PICU
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Level of Fentanyl dosage
Timepoint
Total Fentanyl dosage based on 0.5 - 2 mcg/kg/hr in 24 hours up to end of ventilator support .
Method of measurement
Ramsay Scale has 6 levels : level 1 anxious/agitated and level 6 deep sedation/ no response .Our goal is titrating Fentanyl to maintain patients on levels 2 - 3 (cooperative /respond to command ) .
2
Description
Level of Midazolam dosage
Timepoint
Total Midazolam dosage based on 0.05 - 1 mg/kg in 24 hours up to end of ventilator support .
Method of measurement
Ramsay Scale has 6 levels : level 1 anxious/agitated and level 6 deep sedation/ no response .Our goal is titrating Midazolam to maintain patients on levels 2 - 3 (cooperative /respond to command ) .
Secondary outcomes
1
Description
adverse effects
Timepoint
daily
Method of measurement
observation on signes and symotoms
Intervention groups
1
Description
Treatment group or group 1 : Clonidine with fixed dose 5 μg/kg every 6 hours via NGT(Abidi Pharmaceutical, Iran) plus with variable dose Fentanyl 0.5 - 2 µg/kg/hr and Midazolam 0.05 - 0.1 mg/kg .
Category
Treatment - Drugs
2
Description
Control group: In this group , placebo is administered with variable dose Fentanyl 0.5 - 2 µg/kg/hr and Midazolam 0.05 - 0.1 mg/kg .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofid Children`s Hospital
Full name of responsible person
Sara Salarian
Street address
Shariati Ave , next to Mirdamad St.
City
Tehran
Province
Tehran
Postal code
15468- 155514
Phone
+98 21 2222 7021
Email
sarasalarian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Khodami
Street address
Mofid Chiidren`s Hospital
City
Tehran
Province
Tehran
Postal code
15468- 155514
Phone
+98 21 2222 7021
Email
res.pprc@gmail.com
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 Shahid Beheshti 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
Pediatric Critical Care Unit
Full name of responsible person
Dr. Raha Khosravi
Position
Fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Mofid Children`s Hospital
City
Tehran
Province
Tehran
Postal code
15468- 155514
Phone
+98 21222590004
Fax
Email
drrahakhosravi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pediatric Critical Care Unit
Full name of responsible person
Dr. Sara Salarian
Position
Fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Mofid Children`s Hospital
City
Teharn
Province
Tehran
Postal code
15468- 155514
Phone
+98 21 2225 9004
Fax
Email
sarasalarian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr.Raha Khosravi
Position
Fellow
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Mofid Children`s Hospital, Dr. Shariati Ave.
City
Tehran
Province
Tehran
Postal code
1961743333
Phone
+98 912 892 1152
Email
drrahakhosravi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Demographic and IPD collected for the primary outcome measure
When the data will become available and for how long
After publication
To whom data/document is available
All
Under which criteria data/document could be used
No condition
From where data/document is obtainable
Corresponding author
What processes are involved for a request to access data/document
Sending email to Dr.Raha Khosravi
drrahakhosravi@yahoo.com