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IRCT20211010052721N1 IRCT 2021-10-25 Mashhad University of Medical Sciences The effect of dexamethasone on sudden sensorineural hearing loss Evaluation of dexamethasone injection in the middle ear cavity for the treatment of sudden sensorineural hearing loss and comparison with standard methods 2021-10-23 anticipated 120 Complete https://irct.ir/trial/59306 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization with table of random numbers available at ''www.randomization.com'' website will be used. Numbers will be placed in sealed envelopes and each envelope is assigned to one participant placing them in one of the two groups, Blinding description: The subjects and those evaluating the outcome will be unaware of the intervention and control groups. 3 Sudden sensorineural hearing loss. Intervention 1: First Intervention group: In this group, 40 patients with sudden sensorineural hearing loss (SSNHL) in addition to routine treatment, would take middle ear cavity injection of dexamethasone in the amount of 0.5 cc twice a day for 10 days. Intervention 2: Second Intervention group: In this group, 40 patients with sudden sensorineural hearing loss (SSNHL) in addition to routine treatment, injection of dexamethasone in the middle ear cavity amount of 0.5 cc once a day for 10 days. Intervention 3: Control group: In this group, 40 patients with sudden sensorineural hearing loss (SSNHL) in addition to routine treatment, injection of dexamethasone in the middle ear cavity amount of 0.5 cc and three times every 4 days in a 12-day period is performed, which is the guideline standard method of the American Society of Otolaryngology. 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 After finishing work, consult with colleagues and it will be published if all members
public Navid Nourizadeh
Imam Reza (AS) Hospital, Imam Reza (AS) Square,Ibn Sina St.
Mashhad Iran (Islamic Republic of) 91379 13316 +98 51 3854 3031 nourizadehn@mums.ac.ir Mashhad University of Medical Sciences scientific Navid Nourizadeh
Imam Reza (AS) Hospital, Imam Reza (AS) Square,Ibn Sina St.
Mashhad Iran (Islamic Republic of) 91379 13316 +98 51 3854 3031 nourizadehn@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients with sudden sensorineural hearing loss lasting from 72 hours to less than 30 days after the onset of symptoms Conscious consent to participate in the study 18 years 60 years Both Consumption other medications in addition to prescribed medicationsPregnancy Allergy to prescription drugs Known genetic neurosensory deafness or known anomaly of the inner ear Pregnancy Breastfeeding H90.4 Sensorineural hearing loss, unilateral with unrestricted hearing on the contralateral side Treatment - Drugs Treatment - Drugs Treatment - Drugs First Intervention group: In this group, 40 patients with sudden sensorineural hearing loss (SSNHL) in addition to routine treatment, would take middle ear cavity injection of dexamethasone in the amount of 0.5 cc twice a day for 10 days Second Intervention group: In this group, 40 patients with sudden sensorineural hearing loss (SSNHL) in addition to routine treatment, injection of dexamethasone in the middle ear cavity amount of 0.5 cc once a day for 10 days Control group: In this group, 40 patients with sudden sensorineural hearing loss (SSNHL) in addition to routine treatment, injection of dexamethasone in the middle ear cavity amount of 0.5 cc and three times every 4 days in a 12-day period is performed, which is the guideline standard method of the American Society of Otolaryngology Average hearing threshold. Timepoint: Mean hearing threshold before study and 10 and 12 days after using dexamethasone. Method of measurement: Audiometry. Mashhad University of Medical Sciences Approved 2020-02-18 Ethics committee of Mashhad University of Medical Science Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)