Compare the efficacy of aluminum chloride gel / 25% with phenylephrine drop for control of bleeding in patients with idiopathic epistaxis in the emergency department.
The study population include,patients with epistaxis referring (without age restriction) to emergency department of Al-Zahra and Kashani Hospitals in Isfahan, then they are divided into two groups.Sample size is calculated as 59 in each group, phenylephrine drop group and aluminum-chloride gel (0.25%) group.Medications are prepared by a nurse who is not involved in treatment and is provided to the treatment team.After the interventions, patients in both groups will remain in the emergency department for up to 30 minutes and will be monitored every 5 minutes to record bleeding control time. Also, the cut-off bleeding time will be recorded in the first 10 minutes, and after discharge, patients will be monitored for recurrence of bleeding within one day (24 hours). Finally, the patients' satisfaction rate will be measured based on a score of 0 (dissatisfaction) of up to 10 (complete satisfaction).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Entry Criteria: Patients with anterior nasal bleeding and idiopathic cause will be included in the study.
Exclusion criteria:The cause of nosebleedings due to posterior epistaxis or trauma , and with a history of bleeding disorders such as thrombocytopenia and platelet disorders
Intervention groups
In the intervention group, epistaxis was controlled with aluminum-chloride gel (0.25%).
In the control group, phenylephrine drop will be used for for the treatment of epistaxis.
Main outcome variables
Epistaxis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180129038549N6
Registration date:2018-05-04, 1397/02/14
Registration timing:registered_while_recruiting
Last update:2018-05-04, 1397/02/14
Update count:0
Registration date
2018-05-04, 1397/02/14
Registrant information
Name
Farhad Heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3786 8804
Email address
drfarhadheydari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Efficacy of Aluminum Chloride Gel with Topical Phenylephrine Drops in Control of Epistaxis
Public title
Efficacy of the topical Aluminum chloride 25/% gel in treatment of Epistaxis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Anterior Epistaxis
Exclusion criteria:
Trauma
Posterior epistaxis
History of bleeding disorders
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
118
Randomization (investigator's opinion)
Randomized
Randomization description
A computer-generated random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
Drugs in two groups A and B are prepared by a nurse who is not involved in the treatment of patients. In one group, phenylephrine drops and in the other group aluminum chloride gel (0.25%) will be used to control of epistaxis. Patients and nurses are unaware of the contents of the medications. Also, the investigator and the data collector are not aware of the contents of the drugs.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Alzahra hospital,Sofe Ave., Shahid Keshvari Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Approval date
2017-07-25, 1396/05/03
Ethics committee reference number
ir.mui.rec.1390.3.688
Health conditions studied
1
Description of health condition studied
Epistaxis
ICD-10 code
R04.0
ICD-10 code description
Epistaxis
Primary outcomes
1
Description
Epistaxis control
Timepoint
Every 5 minutes
Method of measurement
Physical exam
Secondary outcomes
1
Description
Time to stop nose bleeding
Timepoint
Up 30 minutes
Method of measurement
Physical exam
2
Description
Rebleeding
Timepoint
Up to 24 hours
Method of measurement
Physical exam
3
Description
Patient Satisfaction
Timepoint
Up to 30 minutes
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: Aluminum chloride gel (0.25%) will be used to control nosebleedings.
Category
Treatment - Drugs
2
Description
Control group: Phenylephrine drop will be used to control epistaxis.