Our aim in this study is to evaluate the effect of 2% citric acid on control of spontaneous epistaxis. In a unicentral clinical trial, 200 patients from both genders with spontaneous epistaxis referring to emergency ward of Emam Reza hospital, Tabriz, Iran will be administered 5 drops of Acid Citric 2% nasal drop in the involved nose. Vital signs will be checked 2 minutes before and 5, 10 and 20 minutes after the instillation and patients will be followed for the next 24 hours for control of bleeding. In case of non-recovery within 5 minutes of Acid citric instillation, standard therapy by anterior tampon will be applied. Gathered data would be then compared using statistical methods.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012091510843N1
Registration date:2012-10-03, 1391/07/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-10-03, 1391/07/12
Registrant information
Name
Peyman Moharramzadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1337 2621
Email address
moharramzadep@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2012-04-04, 1391/01/16
Expected recruitment end date
2012-10-06, 1391/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of 2% citric acid on control of spontaneous epistaxis in patients with spontaneous epistaxis referring to emergency ward
Public title
effect of 2% citric acid on control of spontaneous epistaxis in
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (to have spontaneous epistaxis)
Exclusion criteria: (to have a prior history of coagulopathy; trauma; vascular abnormalities)
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Tabriz University of Medical Sciences
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Daneshgah Square
City
Tabriz
Postal code
Approval date
2012-04-02, 1391/01/14
Ethics committee reference number
9185
Health conditions studied
1
Description of health condition studied
Epistaxis
ICD-10 code
R04.0
ICD-10 code description
Epistaxis
Primary outcomes
1
Description
Nasal bleeding
Timepoint
5, 10 and 20 minutes after the instillation of the drops
Method of measurement
Physical examination by the physician
2
Description
Blood pressure
Timepoint
2 minutes before and 5, 10 and 20 minutes after the instillation of the drops
Method of measurement
By the physician using a Mercury sphygmomanometer
3
Description
Pulse rate per minute
Timepoint
2 minutes before and 5, 10 and 20 minutes after the instillation of the drops
Method of measurement
By the physician
Secondary outcomes
empty
Intervention groups
1
Description
All the individuals will be administered 5 drops of Acid Citric 2% nasal drop in the involved nose.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emergency ward of Emam Reza hospital
Full name of responsible person
Peyman Moharramzaeh
Street address
Emergency ward, Emam Reza hospital, Golgasht ave.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostad Rahimi
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Daneshgah Square
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Peyman Moharramzadeh
Position
Emergency medcine specialist/assistant professor
Other areas of specialty/work
Street address
Emergency ward, Emam Reza hospital, Golgasht ave
City
Tabriz
Postal code
Phone
+98 41 1335 7310
Fax
Email
moharramzadep@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Peyman Moharramzadeh
Position
Emergency medcine specialist/assistant professor
Other areas of specialty/work
Street address
Emergency ward, Emam Reza hospital, Golgasht ave.
City
Tabriz
Postal code
Phone
+98 41 1335 7310
Fax
Email
moharramzadep@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Hemmati
Position
General Physician
Other areas of specialty/work
Street address
Emergency ward, Emam Reza hospital, Golgasht ave
City
Tabriz
Postal code
Phone
Fax
Email
Mehdi.hemmati@rocketmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)