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IRCT20200610047724N1 IRCT 2020-08-11 Islamic Azad University Evaluation of watchful waiting strategy in children with acute otittis media child otitis media study(COMS) Evaluation of watchful waiting strategy in the treatment of acute otitis media in children 6 month to 18 years of age 2019-03-21 anticipated 100 Complete https://irct.ir/trial/48885 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: The watchful waiting intervention in our study is non-pharmacological. Patients do not have a control group. All patients put on watchful waiting strategy at first except in critical cases. Within 72 hours, those patients who do not respond properly will receive antibiotics. N/A Acute otitis media. All patients enrolled to the study with a diagnosis of middle ear infection, if they do not meet the conditions for immediate and emergency antibiotic administration, the treatment decision will be based on watchful waiting ,that means the child will be monitored up to 72 hours without antibiotics prescription (only simple analgesics such as acetaminophen if necessary). Antibiotics are prescribed if warning signs such as worsening of the patient's general symptoms, uncontrollable fever, vomiting, lethargy and intolerance to food are detected within 72 hours. During this period, we monitor the child's symptoms through face-to-face or telephone examination and observation of symptoms and signs .The group has been treated without treatment only under supervision will be the watchful waiting group and those who have not responded in this way and we have to prescribe antibiotics will be in the antibiotic group.Then both groups will be compare in terms of different variables such as sex ,age, post nasal discharge ,adenoid hypertrophy unilateral or bilateral ears involvement and history of atopic conditions.. Yes - There is a plan to make this available What will be shared: Demographic Information of Patients, Clinical Symptoms and signs, therapeutic approach including Watchful and waiting versus antibiotic therapy will be available When: Start the access period 3 months after printing the results To whom: All academic and non-academic researchers Conditions: In order to design and perform similar interventions at a larger size, access to data and applied analysis is possible. Where to obtain: Personal email, mobile number and work phone number of researcher. How to obtain: Documents will be sent within 4 to 8 weeks after the application Comments:
public Mahnaz Haghighi
No.4 , Mollasadra street , Mollasadra medical center , 3Floor
Shiraz Iran (Islamic Republic of) کدپستی۱۵۴۱۱-۷۱۹۳۶ +98 71 3647 2787 haghighi0005@gmail.com Islamic Azad University scientific Mahnaz Haghighi
No.4 , Mollasadra street , Mollasadra medical center , 3Floor
Shiraz Iran (Islamic Republic of) کدپستی۱۵۴۱۱-۷۱۹۳۶ +98 71 3647 2787 haghighi0005@gmail.com Islamic Azad University Iran (Islamic Republic of) children aged between 6 months and 18 years, the presence of mild to moderate AOM, fever less than 39 ° C,no toxicity or pussy discharge from the ears physical exam suggestive for AOM ( acute otitis media) 6 months 15 years Both recent antibiotic use facial or cranial deformities immunodeficiency, malnutrition,HIV history of hearing problems, tympanic membrane perforation frequent history of AOM Down syndrome poor compliance Treatment - Other All patients enrolled to the study with a diagnosis of middle ear infection, if they do not meet the conditions for immediate and emergency antibiotic administration, the treatment decision will be based on watchful waiting ,that means the child will be monitored up to 72 hours without antibiotics prescription (only simple analgesics such as acetaminophen if necessary). Antibiotics are prescribed if warning signs such as worsening of the patient's general symptoms, uncontrollable fever, vomiting, lethargy and intolerance to food are detected within 72 hours. During this period, we monitor the child's symptoms through face-to-face or telephone examination and observation of symptoms and signs .The group has been treated without treatment only under supervision will be the watchful waiting group and those who have not responded in this way and we have to prescribe antibiotics will be in the antibiotic group.Then both groups will be compare in terms of different variables such as sex ,age, post nasal discharge ,adenoid hypertrophy unilateral or bilateral ears involvement and history of atopic conditions. Percentage of children recovering without antibiotics. Timepoint: 72 hours , a week and two weeks after treatment. Method of measurement: Improving the patient's symptoms, including fever and autoscopic ear examinations. Clinical improvement, elimination of ear pain, restlessness, anorexia, general well-being and elimination of inflammation of the eardrum in the examination. Timepoint: First visit ,48 to 72 hours later, One to two weeks after the first visit. Method of measurement: Ear examination and current present illness. Islamic Azad University Approved 2020-06-11 Ethic commitee of Islamic Azad University Kazeroon Branch Shiraz,No.4,Mollasadra Street,Mollasadra medical center,3Floor Shiraz Fars Iran (Islamic Republic of)