If preoperative oral carbohydrate has positive results in reducing pre and post-operative agitation in children, it will be recommended to use it as a routine guideline to reduce the agitation of children who are candidates for surgery.
Design
In this double-blind clinical trial study, 120 children were selected who aged between 6 months and 10 years, were candidates for elective herniorrhaphy and admitted to Motahhari Hospital during the first half of 2019 in Urmia . They were divided randomly into two intervention and control groups by random allocation software.
Settings and conduct
In this double-blind clinical trial study, 120 children were selected who aged between 6 months and 10 years, were candidates for elective herniorrhaphy and admitted to Motahhari Hospital during the first half of 2019 in Urmia . They were divided randomly into two intervention and control groups by random allocation software.
Participants/Inclusion and exclusion criteria
The children who were candidates for elective herniation, aged between 6 months and 10 years, ASA class I and II
Intervention groups
The children who were candidates for inguinal herniorrhaphy received oral carbohydrates.
Main outcome variables
Assessment of the level of children's agitation, probability of vomiting and aspiration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170516033992N1
Registration date:2020-08-26, 1399/06/05
Registration timing:retrospective
Last update:2020-08-26, 1399/06/05
Update count:0
Registration date
2020-08-26, 1399/06/05
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3222 2010
Email address
karami.t@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2019-11-21, 1398/08/30
Actual recruitment start date
2019-07-23, 1398/05/01
Actual recruitment end date
2019-11-21, 1398/08/30
Trial completion date
2020-02-19, 1398/11/30
Scientific title
Assessment of the effect of preoperative oral carbohydrate on the pre and post-operative agitation in children undergoing elective herniorrhaphy
Public title
Assessment of the effect of preoperative oral carbohydrate on agitation in children
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for inguinal hernia repair surgery
َChildren aged between 6 month to 10 years
Exclusion criteria:
American Society of Anesthesiologists (ASA) above class II
Age
From 6 months old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
120
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will conduct based on permuted block randomization method. Each block will have capacity for 4 subjects. Then, within each block, subjects will be randomly assigned to intervention (n=60) or placebo (n=60). Random assignment will be done using a random number table
Blinding (investigator's opinion)
Double blinded
Blinding description
Both of the patients participating in the study and the researcher were unaware of how individuals entered the study and control groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
Jahad Sq., Resalat St., Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5715833631
Approval date
2019-07-22, 1398/04/31
Ethics committee reference number
IR.UMSU.REC.1398.145
Health conditions studied
1
Description of health condition studied
Hernia
ICD-10 code
K41
ICD-10 code description
Femoral hernia
Primary outcomes
1
Description
Agitation in children
Timepoint
Assessment of the level of preoperative agitation and postoperative agitation at 5,15, 30 minutes
Method of measurement
Agitation assessment questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 60 children in the intervention group consumed 5 ml / kg carbohydrate drink exactly 2 hours before the operation
Category
Treatment - Other
2
Description
Control group: 60 children in the intervention group consumed 5 ml / kg distilled water exactly 2 hours before the operation
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Urmia Shahid Motahari University Hospital
Full name of responsible person
Tohid Karami
Street address
Jahad Sq., Resalat St., Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5715833631
Phone
+98 44 3348 9752
Fax
+98 44 3345 7287
Email
karami.tohid@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Tohid Karami
Street address
Jahad Sq., Resalat st., Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5715833631
Phone
+98 44 3193 7000
Fax
+98 44 3345 7287
Email
karami.tohid@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Urmia 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
Oroumia University of Medical Sciences
Full name of responsible person
Tohid Karami
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Jahad Sq., Resalat st., Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5715833631
Phone
+98 44 3193 7000
Fax
+98 44 3345 7287
Email
karami.tohid@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Tohid Karami
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Jahad Sq., Resalat St., Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5715833631
Phone
+98 44 3345 7287
Fax
+98 44 3345 7287
Email
karami.tohid@ gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Tohid Karami
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Jahad Sq., Resalat St., Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5715833631
Phone
+98 44 3193 7000
Fax
+98 44 3346 9931
Email
karami.tohid@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
Individual data will be confidential and the results of the study will be published as an article.
When the data will become available and for how long
2020
To whom data/document is available
The article will be published internationally.
Under which criteria data/document could be used
There is no special condition.
From where data/document is obtainable
Internet
What processes are involved for a request to access data/document