The aim of this study is evaluating Dexamethasone effects on post- tonsillectomy complications in patients , which if it is effective, it can be used routinely.
Design
Controlled clinical trial with parallel groups, double blinded, randomized with table of random numbers
Settings and conduct
In this study, 50 patients candidate for tonsillectomy presenting to Qods teaching hospital, receive 0/15mg/kg IV Dexamethasone at discharging and day 5 after surgery in intervention group and same dose of normal Salin only at discharging, and in 5th and 10th days after surgery, pain ,nausea, vomiting and hemorrhage of both groups assessed. Patients and data analyzer don't inform about their groups and we specialize code to each group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients living in Qazvin city
loss of coagulopathies or Diabetes mellitus
no consumption of corticosteroids or anti- emetic agents
Exclusion criteria:coagulopathies or Diabetes mellitus
consumption of corticosteroids or anti- emetic agents
Intervention groups
In intervention group, we inject 0.15 mg/kg Dexamethasone IV, in time of discharging and 5 days after surgery.
Main outcome variables
nausea, vomiting, hemorrhage, paing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190112042334N1
Registration date:2019-02-09, 1397/11/20
Registration timing:retrospective
Last update:2019-02-09, 1397/11/20
Update count:0
Registration date
2019-02-09, 1397/11/20
Registrant information
Name
Soheyla Faraji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 4807
Email address
omid_gholami@alum.sharif.edu
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-19, 1397/11/30
Expected recruitment end date
2019-04-19, 1398/01/30
Actual recruitment start date
2018-10-11, 1397/07/19
Actual recruitment end date
2018-12-30, 1397/10/09
Trial completion date
2019-01-09, 1397/10/19
Scientific title
Effects Of Dexamethasone On Post-Tonsillectomy complications
Public title
Effects Of Corticosteroids On Tonsil Surgery Complications
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients living in Qazvin city
Loss of Diabetes mellitus or coagulopathies
No consumption of Corticosteroids or Anti-emetic agents
Exclusion criteria:
Coagulopathies or Diabetes mellitus
Consumption of Corticosteroids or anti- emetic agents
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation was done to the study groups. Randomized random numbers were used to randomized.
Blinding (investigator's opinion)
Double blinded
Blinding description
Data analyzer and patients don't know how we intervene and they are in which group. Code was defined for study groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Mavadat alley, Shahid Beheshti Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
13911/34156
Approval date
2017-10-16, 1396/07/24
Ethics committee reference number
IR.QUMS.REC.1396.279
Health conditions studied
1
Description of health condition studied
Post- Tonsillectomy complications
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Determination of pain score by VAS scale and rate of nausea, vomiting and hemorrhage
Timepoint
5th day after tonsillectomy
Method of measurement
visual analogue scale to determine pain score and asking patient about having or not nausea, vomiting and hemorrhage
Secondary outcomes
1
Description
Determination of pain score by VAS scale and rate of nausea, vomiting and hemorrhage
Timepoint
10th day after tonsillectomy
Method of measurement
Using visual analogue scale to determine pain score and asking patient about having or not nausea, vomiting and hemorrhage
Intervention groups
1
Description
Intervention group: 0/15 mg/kg Dexamethason injected for patients intravenously when they discharged and at day 5 after surgery
Category
Treatment - Drugs
2
Description
Control group: 0/15mg/kg normal Saline injected for these patients when they discharged and they receive no medication at day 5 after surgery.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Qods teaching hospital
Full name of responsible person
Soheyla Faraji
Street address
In front of Felestin street, Shahid Beheshti Blvd,Qazvin
City
Qazvin
Province
Qazvin
Postal code
4595-1-34159
Phone
+98 28 3333 4807
Fax
Email
hosghods@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Amir Peymani
Street address
Mavadat alley, Shahid Beheshti Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
13911/34156
Phone
+98 28 3333 4065
Email
research.dpt@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Soheyla Faraji
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3333 6001
Email
sohayla_f7_2012@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Soheyla Faraji
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3333 6001
Email
sohayla_f7_2012@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Soheyla Faraji
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3333 6001
Email
sohayla_f7_2012@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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available