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IRCT20210403050815N1 IRCT 2021-04-10 Shiraz University of Medical Sciences Topical Intranasal Tranexamic Acid in Epistaxis Evaluation of the ٍeffect of Topical Intranasal Tranexamic Acid for Stopping Nose Bleeding in Patients with Epistaxis in the ENT Emergency Department 2021-04-21 anticipated 240 Complete https://irct.ir/trial/55316 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random numbers were generated through computerized block randomization using SPSS software version 23, Blinding description: Participants, care providers, investigators, outcome assessors, and data collectors will be blinded to the topically applied medications used for stopping bleeding. Data Safety and Monitoring Board and manuscript writers will be not blinded. 3 Epistaxis. Intervention 1: Intervention group: In the intervention group, medicated cotton pledgets soaked into IV formulation of tranexamic acid (tranexip, 500mg/5ml, Caspian Tamin) plus phenylephrine nasal drop (Nasopherin, 0.5%, Sina Darou) plus lidocaine solution (10%, Iran Darou) will be inserted in each nostril for 15 minutes for initial epistaxis management in the ED. Intervention 2: Control group: In the control group, medicated cotton pledgets soaked into phenylephrine nasal drop (Nasopherin, 0.5%, Sina Darou) plus lidocaine solution (10%, Iran Darou) will be inserted in each nostril for 15 minutes for initial epistaxis management in the ED. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Milad Hosseinialhashemi
Chamran blvd.
Shiraz Iran (Islamic Republic of) 7194646861 +98 71 3626 7225 miladhashemi88@gmail.com Shiraz University of Medical Sciences scientific Milad Hosseinialhashemi
Chamran blvd.
Shiraz Iran (Islamic Republic of) 7194646861 +98 71 3626 7225 miladhashemi88@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Aged 18 or over Presenting to the Ear, Nose, and Throat emergency department (ED) with spontaneous, atraumatic anterior epistaxis, unresolved with simple first aid 18 years no limit Both Hemodynamically unstable Known allergy to tranexamic acid Lacking capacity or unwilling to give consent Known nasopharyngeal, nasal cavity or paranasal malignancy Pregnancy Already undergone prehospital nasal packing Prisoners Epistaxis caused by trauma (excluding simple nose picking) Any Known bleeding disorders Any recent use of anticoagulation drugs R04.0 Epistaxis Treatment - Drugs Treatment - Drugs Intervention group: In the intervention group, medicated cotton pledgets soaked into IV formulation of tranexamic acid (tranexip, 500mg/5ml, Caspian Tamin) plus phenylephrine nasal drop (Nasopherin, 0.5%, Sina Darou) plus lidocaine solution (10%, Iran Darou) will be inserted in each nostril for 15 minutes for initial epistaxis management in the ED. Control group: In the control group, medicated cotton pledgets soaked into phenylephrine nasal drop (Nasopherin, 0.5%, Sina Darou) plus lidocaine solution (10%, Iran Darou) will be inserted in each nostril for 15 minutes for initial epistaxis management in the ED. Need for use of anterior nasal packing. Timepoint: at any time during that ED attendance after initial management. Method of measurement: determined by clinical judgment. Need for use of electrical cauterization. Timepoint: at any time during ED attendance after initial intervention. Method of measurement: determined by clinical judgment of physician. Rebleeding within 24 hours after presenting to ED. Timepoint: within 24 hours after treatment. Method of measurement: self-statement of the patient with telephone call. Rebleeding within 1-7 days after presenting to ED. Timepoint: 1-7 days after presenting to ED. Method of measurement: self-statement of the patient with telephone call. ED stay more than 2 hours. Timepoint: from presenting to ED to leaving the hospital. Method of measurement: This outcome variable will be evaluated and reported as a qualitative variable. The patients who have been discharged from ED after 2 hours from the presentation will be considered as positive cases for this variable. Shiraz University of Medical Sciences Approved 2020-11-16 Research Ethics Committee of School of Medicine - Shiraz University of Medical Sciences Zand St. Shiraz Fars Iran (Islamic Republic of)