Edema and ecchymosis are two commonly expected consequences of rhinoplasty. Usually Dexamethasone has been suggested for reducing the postoperative edema and ecchymosis associated with rhinoplasty. This study will determine Dexamethasone and Tranexamicacid efficacy on edema and ecchymosis after rhinoplasty. In a double blind clinical trial 70 rhinoplasty patients will be randomized in two groups. Group A will receive Dexamethasone and group B will receive Tranexamicacid. Injection for both groups is a dose of drug before and 3 doses per 8 hours after rhinoplasty. Patients will be evaluated postoperatively at 72 hours for edema and ecchymosis by standard scales.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012291138N5
Registration date:2011-01-31, 1389/11/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-01-31, 1389/11/11
Registrant information
Name
Fataneh Bakhshi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1223 8307
Email address
entrc@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Guilan University of Medical Sciences
Expected recruitment start date
2010-06-22, 1389/04/01
Expected recruitment end date
2011-01-21, 1389/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between Dexamethasone and Tranexamic acid on postoperative edema and ecchymosis in the patients undergoing rhinoplasty
Public title
Comparison between Dexamethasone and Tranexamic acid on postoperative edema and ecchymosis in patients undergoing rhinoplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: - All referents for rhinoplasty. Exclusion criteria: 1- History of peptic ulcer, diabetes, tuberculosis, sensitivity to corticostroids 2- History of using corticostroids 3- History of active infection 4- History of glocoma
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
shahid siadati st.
City
Rasht
Postal code
Approval date
2010-12-11, 1389/09/20
Ethics committee reference number
11623
Health conditions studied
1
Description of health condition studied
rhinoplasty edema and ecchymosis
ICD-10 code
Y84
ICD-10 code description
Other medical procedures as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure
Primary outcomes
1
Description
Edema and ecchymosis
Timepoint
72 hours after rhinoplasty
Method of measurement
Scale for priorbital ecchymosis and eyelid edema
Secondary outcomes
empty
Intervention groups
1
Description
Group A ( Dexamethasone intervention): injection a dose of 8 mg before surgery and then 3 doses per 8 hours after surgery
Category
Treatment - Drugs
2
Description
Group B ( Tranexamic acid intervention): injection a dose of 500 mg before surgery and then 3 doses per 8 hours after surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir-almomenin Hospital
Full name of responsible person
Dr Mir Mohammad Jalali
Street address
17 shahrivar st.
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Guilan University of Medical Sciences
Full name of responsible person
Susan Komaii
Street address
Namjou st.
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Guilan University of Medical Sciences
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
Guilan University of Medical Sciences
Full name of responsible person
Dr Mir Mohammad Jalali
Position
Assistant professor
Other areas of specialty/work
Street address
Amiralmomenin hospital, 17 shahriva st.
City
Rasht
Postal code
Phone
+98 13 1222 5242
Fax
Email
mmjalali@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Mir Mohammad Jalali
Position
Assistant professor
Other areas of specialty/work
Street address
Amir-almomenin hospital, 17 shahrivar st.
City
Rasht
Postal code
Phone
+98 13 1222 5242
Fax
Email
mmjalali@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)