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IRCT20110603006699N4 IRCT 2019-05-28 Esfahan University of Medical Sciences Effect of antibiotic on surgery's complication after tonsillectomy The evaluation of administering oral antibiotics after tonsillectomy on surgery’s complications in patients 2019-05-31 anticipated 52 Complete https://irct.ir/trial/28981 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be selected according to their referral to the ENT Clinic in this study. Using the random function command of Excell software, random numbers will be assigned to each patient by a person independent of the research team and then he/she prints the numbers on small pieces of paper. Then, the papers will be folded so the page with the numbers could not be seen. After putting the papers into a box, another independent person takes 50 paper pieces from the box and puts them into a section which is known as the Antibiotic group, and the other 50 pieces are put in the section known as the No Antibiotic group, Blinding description: Participants will not be informed about the group they are in (control or intervention). Assessors will also be unaware of the patient group. But health care providers, will not be blind due to give Antibiotic to patient. 2-3 tonsillectomy-antibiotics. Intervention 1: Intervention group: oral amoxicillin is given TDS for one week( 40 mg/kg) (Farabi pharmaceutical company). Intervention 2: Control group: The control group does not receive any antibiotics. 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 No further information is available
public Mehrdad Rogha
Kashani Hospital, Kashani Street,Isfehan, Iran
Isfehan Iran (Islamic Republic of) 8183983434 +98 312330098 rogha@med.mui.ac.ir Esfahan University of Medical Sciences scientific Mehrdad Rogha
Kashani Hospital, Kashani Street,Isfehan, Iran
Isfehan Iran (Islamic Republic of) 8183983434 +98 312330098 rogha@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients with tonsillectomy indications such as: adenotonsillar hypertrophia, OSA, oral breathing, deformity in head and face development, problem in talking, chronic recurrent tonsillitis, chronic middle ear infection or recurrent acute middle ear infection. no limit no limit Both Sensitivity to antibiotics like penicillin Pharyngitis symptoms Taking antibiotics within 2 weeks before surgery J35.3 Hypertrophy of tonsils with hypertrophy of adenoids Treatment - Drugs Other Intervention group: oral amoxicillin is given TDS for one week( 40 mg/kg) (Farabi pharmaceutical company) Control group: The control group does not receive any antibiotics The amount of pain after tonsillectomy based on the questionnaire. Timepoint: Measurement of pain 1 and 7 days after tonsillectomy. Method of measurement: visual analogue scale. The incidence of post-tonsillectomy hemorrhage based on the questionnaire. Timepoint: Measuring the incidence of bleeding 1 and 7 days after the operation of tonsillectomy. Method of measurement: Designed questionnaire. The incidence of post-tonsillectomy fever based on the questionnaire. Timepoint: Measuring the incidence of fever 1 and 7 days after the operation of tonsillectomy. Method of measurement: Designed questionnaire. Time to return to regular diet. Timepoint: Measure the time to return to normal diet 14 days after tonsillectomy. Method of measurement: Designed questionnaire. Esfahan University of Medical Sciences Approved 2017-05-17 Ethics committee of Isfahan university of medical science hezar jirib Ave, Isfahan university of medical science Isfahan Isfehan Iran (Islamic Republic of)