Comparing the time of extubation, postoperative apnea incidence, and the quality of perioperative analgesia in infants scheduled for pyloromyotomy-intravenous bolus fentanyl vs rectal acetaminophen
Comparing the time of extubation, postoperative apnea incidence, and the quality of perioperative analgesia in infants scheduled for pyloromyotomy- intravenous bolus fentanyl vs rectal acetaminophen
Design
There are two groups in this research; in the first group we used Fentanyl as a pain relief medicine and in the second group we used rectal Acetaminophen. This study is a double blind study .
Settings and conduct
This study was a randomized double-blind controlled trial and was conducted in Tabriz Children hospital.
Participants/Inclusion and exclusion criteria
Infants witch are candidate for pyloromyotomy (open surgery ) and do not have any other disease .
Intervention groups
24 infants with dx Hypertrophic Pyloric Stenosis which are candidate for pyloromyotomy are divided into two groups;
in fentanyl group fentanyl ( 1μg/kg) and Midazolam will be used as a pain relief and in acetaminophen group for this purpose rectal acetaminophen ( 40mg/kg) will be used 20-30 min before Midazolam .
Main outcome variables
Knowing that patients with Hypertrophic Pyloric Stenosis are at risk of having a long recovery and apnea after surgery; deleting the drug that helps this effect like Fentanyl and replacing it with drugs like Acetaminophen witch dose not have this effect will be useful .
General information
Reason for update
Acronym
HPS
IRCT registration information
IRCT registration number:IRCT20180726040601N1
Registration date:2018-09-24, 1397/07/02
Registration timing:retrospective
Last update:2018-09-24, 1397/07/02
Update count:0
Registration date
2018-09-24, 1397/07/02
Registrant information
Name
Behzad Aliakbari Sharabiani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3330 2648
Email address
sharabiani48@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
2017-02-19, 1395/12/01
Actual recruitment end date
2018-08-23, 1397/06/01
Trial completion date
2018-08-23, 1397/06/01
Scientific title
Comparing the time of extubation, postoperative apnea incidence, and the quality of perioperative analgesia in infants scheduled for pyloromyotomy-intravenous bolus fentanyl vs rectal acetaminophen
Public title
Comparing the time of extubation, postoperative apnea incidence, and the quality of perioperative analgesia in infants scheduled for pyloromyotomy- Intravenous bolus fentanyl vs rectal acetaminophen
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Infants with Hypertrophic Pyloric Stenosis
Having no other problem
Exclusion criteria:
Age more than 2 months
Weight less than 2.5 kg
Preterm labor
Serum Hg less than 10mg/dl
Serum bicarbonate more than 30mmol/l
Serum pH more than 55mmol/L
Using muscle relaxants
Age
From 10 days old to 2 months old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
20
Actual sample size reached:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Using online program: URL:http://WWW.stat.vbc.ca/nrolin/statssize/bz.htmf
Blinding (investigator's opinion)
Double blinded
Blinding description
In this research patients and health care providers and analyzers were not aware of choosing people .
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz university of medical sciences
Street address
Children hospital of Tabriz - Sheshgelan Ave
City
Tabriz
Province
East Azarbaijan
Postal code
1998134753
Approval date
2018-09-15, 1397/06/24
Ethics committee reference number
IR.TBZMED.REC.1397.511
Health conditions studied
1
Description of health condition studied
Hypertrophic Pyloric Stenosis
ICD-10 code
P00-P96
ICD-10 code description
Digestive system disorders of fetus and newborn
Primary outcomes
1
Description
Knowing that patients with Hypertrophic Pyloric Stenosis are at risk of long recovery and apnea after surgery، deleting drugs that cause this effect like Fentanyl and replacing it with Acetaminophen witch dose not have this effect will be useful .(in case of having same pain relief effect ) . in both groups the time of discharging from recovery and the number of apneas that happens in recovery after extubation will be recorded and the effects of this two drugs will be compared at the end .
Timepoint
In Fentanyl group we use Fentanyl as a pain relief with Midazolam and in Acetaminophen group we use rectal Acetaminophen 20-30 min before Midazolam .
Method of measurement
Recovery time with watch -Apnea with pulse oximetry
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Infants with Hypertrophic Pyloric Stenosis witch are candidate for surgery ; in this group we use Fentanyl as a pain relief . in Fentanyl group we will use Fentanyl (1μg/kg) with Midazolam .in both groups the time of discharge from recovery and the number of apneas that happened in recovery will be written .
Category
Prevention
2
Description
Intervention group: Infants with Hypertrophic Pyloric Stenosis witch are candidate for surgery ; in this group we use rectal Acetaminophen as a pain relief. in acetaminophen group we will use rectal Acetaminophen ( 40mg/kg) before Midazolam .
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Children hospital in Tabriz
Full name of responsible person
Behzad Aliakbar Sharabiani
Street address
Children hospital of Tabriz - Sheshgelan Ave
City
Tabriz
Province
East Azarbaijan
Postal code
1998134753
Phone
+98 21 2211 8956
Email
sahar.akbari292@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hasan Soleimanpour
Street address
Tabriz university of medical science-research department-Golgasht Ave .
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 5921
Fax
+98 41 3335 9680
Email
info@medfac.tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Behzad Aliakbar Sharabiani
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Children hospitalof Tabriz- Sheshgelan Ave
City
Tabriz
Province
East Azarbaijan
Postal code
1998134753
Phone
+98 21 2211 8956
Email
sahar.akbari292@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Behzad Aliakbar Sharabiani
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Childrenhospital of Tabriz - Sheshgelan Ave
City
Tabriz
Province
East Azarbaijan
Postal code
1998134753
Phone
+98 21 2211 8956
Email
sharabiani48@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sahar Akbari
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Tehran - Saadat abad - Sarv Ave
City
Tehran
Province
Tehran
Postal code
1998134753
Phone
+98 21 2211 8956
Email
sahar.akbari292@gmail.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
All the information will be shared after hidden the names
When the data will become available and for how long
It will be reachable after publish.
To whom data/document is available
All the information will be reachable for researchers .
Under which criteria data/document could be used
No condition .
From where data/document is obtainable
Children hospital of Tabriz.
What processes are involved for a request to access data/document