1- Comparison of mask acceptance in children undergoing tonsillectomy in two groups of gabapentin and midazolam compared to control group
2- Comparison of changes in mean arterial blood pressure in children undergoing tonsillectomy in two groups of gabapentin and midazolam compared to control group.
3- Comparison of parental separation status in pediatric surgical candidates
4- Comparison of the incidence of amnesia in children undergoing tonsillectomy in two groups of gabapentin and midazolam compared to the control group.
5- Comparison of the incidence of respiratory weakness in children undergoing tonsillectomy in two groups of gabapentin and midazolam compared to the control group.
Design
The sample size was 108 people with design effect
equal 0.3, 5 percent error and 80 percent power using G-power software. Therefore, 36 patients will be included in the study in each group.
Settings and conduct
Matini Hospital.
This study is a double blind clinical trial. In this study, one hundred and eighty three to twelve year old children who are candidates for tonsillectomy who will be referred to Matini Hospital of Kashan in 2019 will be enrolled in this study by simple sampling method.
Participants/Inclusion and exclusion criteria
All 3-12 year-old children undergoing tonsillectomy are referred to Matini Hospital of Kashan.
Intervention groups
1- Gabapentin group received 12.5 mg/kg oral syrup 60 minutes before entering the operating room for the baby.
2- Midazolam 0.5 mg / kg oral dose administered to the infant 60 minutes prior to admission to the operating room
3- The third group received distilled water as the placebo group
Main outcome variables
Proper use of anti-anxiety drugs with limited side effects can minimize anxiety and restlessness in children and minimize side effects after surgery and anesthesia in children.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191103045320N1
Registration date:2019-12-12, 1398/09/21
Registration timing:registered_while_recruiting
Last update:2019-12-12, 1398/09/21
Update count:0
Registration date
2019-12-12, 1398/09/21
Registrant information
Name
Mohammad Shabani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 4422 0704
Email address
mohammadshabaniii77@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-26, 1398/09/05
Expected recruitment end date
2020-02-19, 1398/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Sedative effect of Midazolan and Gabapantin in Pre-Tonsillectomy in Pediatric
Public title
Effect of Gabapantin versus Midazolam in Tonsillectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 3 to 12 years
Candidate for tonsillectomy surgery
Referred to Matini Hospital
Exclusion criteria:
Children with a history of allergy to any of the medications taken
Children who themselves or their parents refuse to take the drug
They had a history of using drugs affecting the central nervous system
They had diseases affecting the central nervous system
They needed emergency surgery
It was estimated that their surgery would last more than one hour
Age
From 3 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Sample size was 108 people with design effect = 0.3, 5% error and 80% power using G-power software. Therefore, 36 patients will be included in the study in each group
Blinding (investigator's opinion)
Triple blinded
Blinding description
1- Parents were required to participate in the study and the patient was not aware of the intervention.
2- The container containing the drugs and placebo was marked with the letters A, B, C, and was also listed on the checklist for information.
3- The data analyzer also analyzed the data according to the letters A, B and C
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kashan University of Medical Sciences
Before prescribing medication, during induction of anesthesia, recovery, discharge from operating room
Method of measurement
Age (year), gender (male and female), weight (kg), temperature (degree C), heart rate (number of minutes), respiratory rate (number of minutes), systolic blood pressure (mmHg) , Diastolic blood pressure (mmHg), headache (yes or no), mask acceptance (no problem or no problem), parental separation (easy or difficult), respiratory weakness (oxygen saturation), chills (yes or no), Double vision (yes or no), forgetfulness (yes or no), bleeding (yes or no), nausea (yes or no), vomiting (yes or no)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: One Gabapentin dose of 12.5 mg / kg oral 60 min before surgery - Midazolam 0.5 mg / kg oral 60 min before surgery
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Matini Hospital
Full name of responsible person
Mohammad Ali Sadati
Street address
Kashan Amir Kabir Ave.
City
Kashan
Province
Isfehan
Postal code
8719674591
Phone
+98 31 5534 2020
Fax
Email
mohammadshabaniii77@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Ali Sadati
Street address
Kashan five kilometers from Ravandi hospital next to Shahid Beheshti Hospital
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5544 3022
Fax
+98 31 5546 4950
Email
info@kaums.ac.ir
Web page address
http://kaums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Shabani
Position
Undergraduate Student of Anesthesiology
Latest degree
A Level or less
Other areas of specialty/work
Anesthesiology
Street address
Razi Street of Shahid Mahmoud Ebrahimi Alley
City
Kashan
Province
Isfehan
Postal code
37911-94955
Phone
+98 86 4422 0704
Email
mohammadshabaniii77@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Ali Sadati
Position
Anesthesiologist Faculty member
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Kashan, Shahid Rajaie Street, Madani Street
City
Kashan
Province
Isfehan
Postal code
87137-5954
Phone
+98 31 5544 6251
Email
dr.m.a.saadati@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Ali Sadati
Position
Anesthesiologist Faculty member
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Kashan, Shahid Rajaie Street, Madani Street
City
Kashan
Province
Isfehan
Postal code
87137-5954
Phone
0355446251
Email
dr.m.a.saadati@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
No - There is not 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
After this example, the selected samples and options are possible in the method
When the data will become available and for how long
Ten months
To whom data/document is available
Executor and supervisor of the project
Under which criteria data/document could be used
If necessary, review information or use it in national surveys
From where data/document is obtainable
To the presenters of the plan
What processes are involved for a request to access data/document
Once approved by the Ethics Committee of the Vice President of Technology Research at the University, access to the documentation will be available