Comparison of three drug groups effectiveness, intravenous Lidocaine and Dexamethasone, intravenous Ketamine and Dexamethasone and Dexamethasone alone in the managment of respiratory complications after tonsillectomy.
Comparison of three drug groups effectiveness, intravenous Lidocaine and Dexamethasone, intravenous Ketamine and Dexamethasone and Dexamethasone alone in the managment of respiratory complications after tonsillectomy.
Design
Clinical trial with control group, parallel groups, double blinded, randomized on 100 patients. Random allocation law and SPSS software are used for randomization.
Settings and conduct
The study was performed on 100 tonsillectomy patients who recieved prepared drugs before extubation and respiratory complications were evaluated in recovery.
The patients and the parents, the statistical researcher and the person collecting the data do not know the study group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All ASA1 patients candidates for elective tonsillectomy surgery aged 2-18 years
Exclusion criteria : Active upper respiratory tract infection during the two weeks before surgery.
Active lower respiratory tract infection within 5 weeks before surgery, history of asthma, history of drug allergies.
Intervention groups
Prior to extubation, each patient receives medication previously prepared in the same syringe volume of 5 cc. After obtaining the necessary conditions for extubation, they are extrubated and transferred to recovery.
The first group of patients recieve Dexamethasone 0.1 mg / kg and Lidocaine 1 mg / kg, the second group recieve Ketamine 0.5 mg / kg and Dexamethasone 0.1 mg / kg, the third group recieve only Dexamethasone 0.1 mg / kg and the fourth group recieve normal saline with the same volume intravenously.
Main outcome variables
Prevention of respiratory complications after pediatric tonsillectomy.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210718051928N1
Registration date:2021-09-06, 1400/06/15
Registration timing:registered_while_recruiting
Last update:2021-09-06, 1400/06/15
Update count:0
Registration date
2021-09-06, 1400/06/15
Registrant information
Name
Somaye Hoghughi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3240 3303
Email address
s.hoghughi70@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-01, 1400/06/10
Expected recruitment end date
2022-03-11, 1400/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of three drug groups effectiveness, intravenous Lidocaine and Dexamethasone, intravenous Ketamine and Dexamethasone and Dexamethasone alone in the managment of respiratory complications after tonsillectomy.
Public title
Comparison of three drug groups effectiveness, intravenous Lidocaine and Dexamethasone, intravenous Ketamine and Dexamethasone and Dexamethasone alone in the managment of respiratory complications after tonsillectomy.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All ASA1 patients are candidates for elective tonsillectomy
Age between 2-18 years
Parental consent
Exclusion criteria:
Active upper respiratory tract infection during the two weeks prior to surgery
Active lower respiratory tract infection during the 5 weeks prior to surgery
History of asthma
History of allergy to Lidocaine , Dexamethasone and Ketamine
ASA2 patients and higher
Age
From 2 years old to 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Within the setting time we enter all patients who have the indication non-randomly.
Patients are then divided into 4 groups according to the law of random allocation.
The SPSS system randomly codes 100 patients, so that each patient who enters the operating room has a specific code based on how many people enter the operating room.
For example, the fourth patient has code B and receives medication in this group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients in 4 groups receive the same volume of drugs and do not know the content of the drugs.
The parents, the statistical researcher and the person collecting the data do not know the study group.
The person preparing the medicine does not know the patients.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjorib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-08-30, 1400/06/08
Ethics committee reference number
IR.MUI.MED.REC.1400.418
Health conditions studied
1
Description of health condition studied
Respiratory complications after tonsillectomy
ICD-10 code
J04.2
ICD-10 code description
Acute laryngotracheitis
Primary outcomes
1
Description
The percentage of people whose airway irritability score is 8-10.
Timepoint
Every ten minutes after entering the recovery and the moment of leaving the recovery.
Method of measurement
Use of airway irritability questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: Dexamethasone 0.1 mg / kg and Lidocaine 1 mg / kg in a 5cc syring with the same volume witch is injected as a single dose before extubation.
Category
Prevention
2
Description
Intervention group2: Ketamine 0.5 mg / kg and Dexamethasone 0.1 mg / kg prepared in a 5cc syring witch is injected as a single dose before extubation.
Category
Prevention
3
Description
Intervention group3: Dexamethasone 0.1 mg / kg prepared in a 5cc syring with the same volume witch is injected as a single dose before extubation.
Category
Prevention
4
Description
Control group4: recieve normal saline with the same volume(5 cc) intravenous befor extubation.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan medical science educatinal Hospitals
Full name of responsible person
seyed Morteza Heidari
Street address
Isfahan univercity of medical science,Hezarjarib Ave
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3240 3303
Email
yameisam@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Beheshte Toghyani
Street address
Isfahan univercity of medical science, Hezarjarib Ave
City
اصفهان
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
yameisam@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan univercity of medical science
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
Esfahan University of Medical Sciences
Full name of responsible person
Somayye Hoghughi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Isfahan univercity of medical science, Hezarjarib Ave
City
اصفهان
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3240 3303
Email
yameisam@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Somayye Hoghughi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Isfahan univercity of medical science
City
اصفهان
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3240 3303
Email
yameisam@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Seyed Morteza Heidari
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Isfahan univercity of medical science, Hezarjarib Ave
City
اصفهان
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 8670 5503
Email
yameisam@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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The questionnaire and statistical data will be published without individual patient data .
When the data will become available and for how long
After completing the research.
To whom data/document is available
Researchers from academic institutions will have access.
Under which criteria data/document could be used
Any kind of scientific analysis is allowed.
From where data/document is obtainable
Dr. Seyed Morteza Heidari and Somayeh Hoghughi, whose full contact information was provided in the previous sections.
What processes are involved for a request to access data/document
For a week after making the call, the information will be provided.