1.Comparison of the effect of normal serum glucose stabilization of cold saline after surgery on the pain of the site of operation Tonsillectomy / Adenotonsillectomy by routine method
2.Comparison of the effect of normalizing serum saline with honey after surgery on pain in the site of operation Tonsillectomy / Adenotonsillectomy by routine method
3.Comparison of the effect of normal serum saline normalization with honey with normal cold saline after surgery on pain in the site of operation Tonsillectomy / Adenotonsillectomy
Design
Clinical trials with control group, community based and pragmatic, with parallel groups, double blind, randomized
Settings and conduct
Hospital of Bojnourd University of Medical Sciences. The research population of patients aged between 5-14 years of age who are candidates for Tonsillectomy / Admontonsillectomy who are ASA (class of Association of American Anesthesiology Association) in grade one and two after receiving written consent from the parents of the patient, samples The target group will consist of 35 people in each group. All patients will be operated by a surgeon and undergo general anesthesia.
Participants/Inclusion and exclusion criteria
Criteria for entering the study:
Tonsillectomy / Elective adenotonsillectomy
ASA class one and two
Aged 5-14 years old
Obtaining written consent from the patient
Exit for criteria the study:
Need to re-intubate
Bleeding and needing re-operation
Failure to intubate the chip
Bleeding disorders
Systemic diseases like diabetes
Intervention groups
Normal saline (NC) groups, normal saline group with honey (NH) and normal saline (temperature) (control group) (N)
Main outcome variables
The amount of pain, weight, hemorrhage, child's relaxation before and after surgery, sleep before and after the child, nausea and vomiting, breathing situation, throat itching
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190113042346N1
Registration date:2019-02-10, 1397/11/21
Registration timing:registered_while_recruiting
Last update:2019-02-10, 1397/11/21
Update count:0
Registration date
2019-02-10, 1397/11/21
Registrant information
Name
hosnieh raufiyan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3657 6830
Email address
h.raufyian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of normal saline cold grass with honey and normal saline cold on the pain of children`s tonsillectomy/adenotonsillectomy
Public title
Comparison of the effect of normal saline cold grass with honey and normal saline cold on the pain of children`s tonsillectomy/adenotonsillectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Tonsillectomy / Elective adenotonsillectomy
ASA class one and two
Aged 5-14 years old
Obtaining written consent from the patient
Exclusion criteria:
Need to re-intubate
Bleeding and needing re-operation
Failure to intubate the chip
Bleeding disorders
Systemic diseases like diabetes
Age
From 5 years old to 14 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be referred to on a regular basis. Patient allocation will be done in groups of this study using Block Randomization. In this way, by determining the blocks and randomly choosing blocks, the patient number received by the group of three The frequency is determined and then the number of patients in the group according to the requirements of the code is specified and according to the codes, gradually, by referring the patients to the intervention is done. To determine the normal saline (NC) intervention groups, the normal saline group with honey (NH) and normal saline is also characterized by temperature (control group) (N). And patients are given four-digit code
Blinding (investigator's opinion)
Double blinded
Blinding description
To blind people, patients who do not wake up will not notice that they are in the group's custody, and the pain assessor will not be informed about which group the patient is in.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Deputy of Research and Technology of Mazandaran University of Medical Sciences
Street address
Sari, Three streams Joybar, Beginning of Valiasr highway, central headquarters of Mazandaran University of Medical Sciences and Health Services
When clearance is recovered, and at intervals every 6 hours on the first day, the end of the first day, the end of the second day
Method of measurement
For the assessment of pain, Wang Baker's scale for children will be used for children.
Secondary outcomes
empty
Intervention groups
1
Description
Intervetion groupe: First intervention: In the normal group of saline with honey (NH) at the end of the operation, the pharyngeal cavity and around the tonsils at the end of the operation with normal saline 0.9%, the temperature with the room washed and cleaned and then suctioned, and after the operation, the patient's pain It is recorded in the recovery at the time of discharge and every 6 hours for two days gargle the normal solution of saline 0.9% to 100 cc at a concentration of 10/10 with mixed honey (100 ml of honey mixed per liter of normal saline) The patient is given and after each time gargle the pain is recorded and the pain will be recorded on the first and second day after the sharp operation. Second intervention: In the normal saline group, 4 ° C (NC) was washed and cleaned at the end of the oral cavity and around the tonsil with normal saline 0.9% and then suctioned and recorded in the recovery procedure at the time of discharge. A normal saline solution was placed in the refrigerator and using the thermometer in the refrigerator, the solution temperature would be used when it reached 4 ° C, and every 6 hours the normal solution of saline was 0.9% cold at 4 ° C at 100 cc by the gargoyle patient And the amount of pain after gargoying each time and on the first and second day after the operation will be recorded.
Category
Treatment - Surgery
2
Description
Control group: In the control group (N), the routine routine washing of the pharyngeal cavity and around the tonsils at the end of the surgery will be done, and the pain will be recorded in recovery and every 6 hours on the first and second day after the operation. And there will be no intervention
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hassan Hospital
Full name of responsible person
Reza Ghaffari
Street address
Bojnourd - Orcan road, above wheat silo,Imam Hasan educational, research and therapeutic center
City
Bojnord
Province
North Khorasan
Postal code
945315174
Phone
+98 58 3151 0000
Email
h.raufyian@Gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Said Majidi
Street address
Sari, Imam Square, Three Way Joybar, Beginning of Vali-e-Asr Highway, Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3448 4800
Email
msaeidi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Hosnieh Raufiyan
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Toos Boulevard, Toos 65, Najaf 34, Milan 1st to the right, Third door to the right
City
mashhad
Province
Razavi Khorasan
Postal code
9198185477
Phone
+98 51 3657 6830
Email
h.raufyian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim Nasiri Formi
Position
Assistant Professor, collegian
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Sari, Three streams Joyber, Beginning of Valiasr highway, central headquarters of Mazandaran University of Medical Sciences and Health Services
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3304 4000
Email
rezanf2002@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hosnieh Raufiyan
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Toos Boulevard, Toos 65, Najaf 34, Milan 1st to the right, Third door to the right
City
mashhad
Province
Razavi Khorasan
Postal code
9198185477
Phone
+98 51 3657 6830
Email
h.raufyian@gmail.com
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
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
Undecided - It is not yet known if there will be 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
We will record the data obtained after the illness.
When the data will become available and for how long
Get started 6 months after printing resultsمحققین
To whom data/document is available
Researchers and researchers at academic and academic institutions
Under which criteria data/document could be used
Using the source and the researchers' satisfaction, this study is applicable
From where data/document is obtainable
Can contact Hosnieh Raufiyan at h.raufyian@gmail.com
What processes are involved for a request to access data/document
Upon receipt of a request for access to the document, it will be delivered to the maximum of up to two months