Comparison of demographic characteristics in the control group with the intervention group; determining the intensity of pain after tonsil surgery in the intervention group at 4, 8, 12, and 24 hours; comparison of pain intensity after tonsil surgery in the intervention and control groups at 4, 8, 12, and 24 hours; comparison of heart rate during tonsillectomy in intervention and control groups; Comparison of systolic and diastolic blood pressure during tonsillectomy in intervention and control groups; comparison of arterial blood oxygen saturation percentage during tonsillectomy in the intervention and control groups; comparison of the duration of anesthesia during tonsillectomy in intervention and control groups; comparison of the recovery period in intervention and control group
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 on 35 patients. The rand function of Excel software was used for randomization.
Settings and conduct
A double-blind randomized prospective clinical trial in the center Heshmatieh Sabzevar educational therapy.
The drug dexmedetomidine and normal saline with the same volume and in the same shape syringes are prepared by an anesthetist who knows the content of the research and is fully justified and is marked with code A or B. In this way, the researcher evaluates the patients only based on the code without knowing whether the patient is in the dexmedetomidine group or normal saline.
Participants/Inclusion and exclusion criteria
Candidate for tonsillectomy surgery; 4 to 15 years
Intervention groups
Intervention group with dexmedetomidine and normal saline
Main outcome variables
"Intensity of pain after tonsil surgery"; "Arterial blood oxygen saturation percentage during tonsillectomy"; "Heartbeat during tonsillectomy"; "Systolic and diastolic blood pressure during tonsillectomy"; "Recovery time"
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220508054785N1
Registration date:2022-08-31, 1401/06/09
Registration timing:prospective
Last update:2022-08-31, 1401/06/09
Update count:0
Registration date
2022-08-31, 1401/06/09
Registrant information
Name
Mahdieh Kalateh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4422 5758
Email address
kalatehm95@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2023-02-19, 1401/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Submucosal injection of dexmedetomidine in reduction of postoperative pain in pediatric tonsillectomy
Public title
Injection of dexmedetomidine in reduction of pain in pediatrics tonsillectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for tonsillectomy surgery
4 to 15 years
ASA class I&II
No peritonsillar abscess
No chronic pain
Not taking painkillers 24 hours before surgery
Exclusion criteria:
Parents' lack of consent to continue attending the study
History of allergy to any medicine
Coagulation disorder
Liver disorders
Uncontrolled diabetes (ASA 3 and above)
Active upper respiratory tract infection
Occurrence of complications during surgery
Increasing the recovery period to more than 60 minutes
Increasing the duration of surgery
Age
From 4 years old to 15 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
35
Randomization (investigator's opinion)
Randomized
Randomization description
this project which is actually a clinical trial aims to investigate the injection of dexmedetomidine in reduction of pain in pediatrics tonsillectomy patients who are divided into intervention and control group based on permutation block.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drug dexmedetomidine and normal saline with the same volume and in the same shape syringes are prepared by an anesthetist who knows the content of the research and is fully justified and is marked with code A or B. In this way, the researcher evaluates the patients only based on the code without knowing whether the patient is in the dexmedetomidine or normal saline group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Sabzevar University of Medical Sciences
Street address
Medical School, Education Vice-Chancellor, University Campus Building, Tawheed Shahr Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Approval date
2022-02-13, 1400/11/24
Ethics committee reference number
IR.MEDSAB.REC.1400.153
Health conditions studied
1
Description of health condition studied
Tonsillectomy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Severity of pain after tonsil surgery
Timepoint
4, 8, 12 and 24 after the intervention
Method of measurement
Faces Pain Scale-Revised (FPS-R)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: anaesthesia is induced by fentanyl 4 μg/kg &and propefol 2 μg/kg & atracurium 0.4 μg/kg after 3 minutes tracheal intubation and ventilation are performed and anaesthesia is maintained with nitrousoxide50% and oxygen 50% and isoflorane1.2 . the children were locally infiltrated with 1 μg/kg dexmedetomidine into the pretonsillar space by sergeon { between upper and lower parts of tonsils}
Category
Treatment - Drugs
2
Description
Control group: anaesthesia is induced by fentanyl 4 μg/kg &and propefol 2 μg/kg & atracurium 0.4 μg/kg after 3 minutes tracheal intubation and ventilation are performed and anaesthesia is maintained with nitrousoxide50% and oxygen 50% and isoflorane1.2 .after anaesthesia normal saline with the same volume and in the same shape syringes with dexmetedomine are prepared and were locally infiltrated into the peritonsillar space by surgeon.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Heshmatieh Sabzevar Medical Education Center
Full name of responsible person
Mahdieh kalateh
Street address
Medical School, Education Vice-Chancellor, University Campus Building, Tawheed Shahr Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 8300
Email
mahdieh.kalateh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mohammad Hossein Saghi
Street address
Medical School, Education Vice-Chancellor, University Campus Building, Tawheed Shahr Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 8300
Email
saghi9@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Shakiba mozari
Position
Assistant professor, specialist physician, academic staf
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Medical School, Education Vice-Chancellor, University Campus Building, Tawheed Shahr Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 8300
Email
sh.mozari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Shakiba mozari
Position
Assistant professor, specialist doctor, academic staff
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Medical School, Education Vice-Chancellor, University Campus Building, Tawheed Shahr Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 8300
Email
sh.mozari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mahdieh Kalateh
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Medical School, Education Vice-Chancellor, University Campus Building, Tawheed Shahr Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 8300
Email
mahdieh.kalateh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
--
When the data will become available and for how long
--
To whom data/document is available
--
Under which criteria data/document could be used
--
From where data/document is obtainable
--
What processes are involved for a request to access data/document