Reason of this study is comparing effect of triamciniline ointment in pain control and bleeding after tonsillectomy surgery in comparision with only suturing.For this object,150 patients suffering from tonsilitis after study from age,sex and other diseases they devided to two groups of case and control that is one side blind method and patients do not know their groups and comparing measure of pain ,bleeding,starting oral feeding and time of fibrin layer formation at 6,12,24 hours after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201608174374N3
Registration date:2017-09-06, 1396/06/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-06, 1396/06/15
Registrant information
Name
Seiedreza Seiedmohammaddoulabi
Name of organization / entity
shahid beheshti university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 21 3333 9755
Email address
s8371916@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University Of Medical Sciences
Expected recruitment start date
2016-10-01, 1395/07/10
Expected recruitment end date
2017-03-01, 1395/12/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of effect of triamsinolon ointment in control of hemorrhage and pain after tonsilectomy compare with using suture.
Public title
The study of effect of triamsinolon ointment in control of hemorrhagea after tonsillectomy surgery.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria the 7-29 years old patients in loqman hakim hospital that do tonsilectomy sergury and exclusion criteria blood abnormality and hemorrhage tendency.
Age
From 7 years old to 29 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University Of Medical Sciense"assistance of research center"
Street address
daneshgah street shahid chamran highway
City
Ttehran
Postal code
Approval date
2016-04-10, 1395/01/22
Ethics committee reference number
ir.sbmu.retech.rec.1395.4
Health conditions studied
1
Description of health condition studied
Hypertrophy of tonsils
ICD-10 code
J35.1
ICD-10 code description
J03.8
Primary outcomes
1
Description
Hemorrhage
Timepoint
6-12-24 hour after tonsillectomy
Method of measurement
Observation
2
Description
Pain after surgery
Timepoint
6,12,24 hours after surgery
Method of measurement
scale of pain
Secondary outcomes
1
Description
Time of formation fibrin membran
Timepoint
24 hours after surgery
Method of measurement
Observation
Intervention groups
1
Description
use topical ointment triamsinolon after tonsilectomy for case group
Category
Treatment - Drugs
2
Description
Control group use suture for site of surgery.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Loqman Hakim Hospital
Full name of responsible person
Navid Ahmadi roozbahani
Street address
Kamali street, Karegar street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University Of Medical Sciense
Full name of responsible person
Navid Ahmadi Rouzbahani
Street address
Loqman Hakim Hospital , Kamali street , Karegar street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University Of Medical Sciense
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University Of Medical Sciens
Full name of responsible person
SeiedReza SeiedMohammadDoulabi
Position
resident of Ent
Other areas of specialty/work
Street address
Loqman Hakim Hospital , Kamali street , Karegar street
City
Tehran
Postal code
Phone
+98 21 5102 5000
Fax
Email
javad_9423@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Loqman Hakim Hospital
Full name of responsible person
Navid Ahmadi Rouzbahani
Position
ent specialist
Other areas of specialty/work
Street address
Loqman Hakim Hospital, Kamali street, Karegar street
City
Tehran
Postal code
Phone
+98 21 5102 5000
Fax
Email
navidar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Loqman Hakim Hospital
Full name of responsible person
Fahime Shamsian
Position
Medical Student
Other areas of specialty/work
Street address
Loqman Hakim Hospital, Kamali street, Karegar street
City
Tehran
Postal code
Phone
+98 21 5102 5000
Fax
Email
fahime.shamsian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)