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IRCT20111224008507N2 IRCT 2018-07-09 Mazandaran University of Medical Sciences Comparing the treatment of acute otitis media with Amoxicillin and watchful waiting in 6 months to 6 years old children Clinical trial of the effectiveness of comparing the treatment of acute otitis media with Amoxicillin and watchful waiting in 6 months to 6 years old children 2017-05-22 anticipated 200 Complete https://irct.ir/trial/30848 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After obtaining informed consent for randomization form parents of children, patients were placed in intervention (amoxicillin) and control group (watchful waiting) by entering in blocks of four and randomized division, Blinding description: Data analyser was blinded. 3 Otitis media. Intervention 1: Intervention group: For the intervention group, 80 mg/kg/day Amoxicillin suspension manufactured by Farabi co. with brand name of Faramox BD will be given for at least 7 days. Intervention 2: Control group: The control group is followed up without antibiotic therapy and with monitoring and evaluation of symptoms. In this group, only patients who are allowed not to use antibiotic treatment and can be expected with care are enrolled under AOM's guideline. Yes - There is a plan to make this available What will be shared: Part of the data is available When: En starting in January 2020 To whom: All people Conditions: Nothing Where to obtain: Contact Dr. Ensieh Talaei. E-mail: nctalaei@gmail.com How to obtain: After a call, information is sent within a few days Comments:
public Ensieh Talaei
Bouali Hospital, Pasdaran boulevard, Sari
Sari Iran (Islamic Republic of) 47128-55689 +98 11 3334 2334 nasimmeh62@yahoo.com Mazandaran University of Medical Sciences scientific Mohammadsadegh Rezai
Bouali Hospital, Pasdaran Boulevard, Sari
Sari Iran (Islamic Republic of) 47128-55689 +98 11 3334 2334 drmsrezaii@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Age 6 months to 6 years Acute otitis media with signs started within 48 hours Not having severe symptoms and ear otorrhea Unilateral or bilateral involvement 6 months 6 years Both Severe otalgia Fever higher than 39 degrees Underlying diseases such as immunodeficiency (except asthma and allergy) Amoxicillin intake in the last 30 days Concurrent conjunctivitis Ear otorrhea H65.1 Other acute nonsuppurative otitis media Treatment - Drugs Treatment - Other Intervention group: For the intervention group, 80 mg/kg/day Amoxicillin suspension manufactured by Farabi co. with brand name of Faramox BD will be given for at least 7 days. Control group: The control group is followed up without antibiotic therapy and with monitoring and evaluation of symptoms. In this group, only patients who are allowed not to use antibiotic treatment and can be expected with care are enrolled under AOM's guideline. Fever. Timepoint: At the beginning of the study (before the intervention), three days after treatment. Method of measurement: Thermometer. Otalgia. Timepoint: At the beginning of the study (before the intervention), three days after treatment. Method of measurement: Observation. Mastoiditis. Timepoint: At the beginning of the study (before the intervention), three days after treatment. Method of measurement: Examination. Middle ear effusion. Timepoint: At the beginning of the study (before the intervention), three days after treatment. Method of measurement: Examination. Frequency of acute otitis media. Timepoint: One and three months after treatment. Method of measurement: Observation. Middle ear effusion. Timepoint: One and three months after treatment. Method of measurement: Examination. Mazandaran University of Medical Sciences Approved 2017-08-01 Ethics committee of Mazandaran University of Medical Sciences Vice chancellor for Research, Moallem square, Sari Sari Mazandaran Iran (Islamic Republic of)