Comparison of Cefuroxime and Co-Amoxiclav on the treatment of pediatric bacterial sinusitis

Comparison of the effects of Cefuroxime and Co-Amoxiclav in the treatment of acute bacterial sinusitis in children

Clinical trial, with parallel groups, double-blind, randomized, phase 3 on 280 patients. The rand function of Excel software was used for randomization.

The place of study will be Shahid Beheshti Hospital, Kashan, for children with sinusitis who are referred to the clinic. After prescribing the drugs and examining the patients, the requested variables will be evaluated. The interventions in the two groups are so similar in terms of shape, color, taste, method of consumption, etc. that blinding at the participant level is possible. This goal will be achieved with the cooperation of the outpatient pharmacy unit and the pharmacist. On the other hand, the coding is done by one of the colleagues of the project, and the doctor, the evaluator, and the patient are blind to the way the patients are coded.

Inclusion criteria: Children from 6 months to 14 years are referred to the Beheshti Hospital clinic in Kashan Clinical diagnosis of acute bacterial sinusitis, based on clinical criteria and diagnosis and confirmation by a pediatric infectious disease specialist Exclusion criteria: Sinusitis over 4 weeks History of chronic sinusitis or allergic rhinitis

To the first group, Cefuroxime suspension syrup 250 mg (20 to 30 mg per kg every 12 hours a day), and to the second group Co-Amoxiclav 125 mg, with a dose of 80 mg/kg/day/divided into three doses each 8 hours/maximum 3 grams per day, given for ten days.

Runny and stuffy nose, purulent discharge from the nose, headache and pain in the sinuses, cough, fever, earache, sore throat.

Randomization method: block method Randomization unit: individual Randomization tool: a table of random numbers will be prepared by a computer, and the patients will be divided into 2 groups by the doctor using the table of random numbers taken from the computer.

The interventions in the two groups are so similar in shape, color, taste, method of consumption, etc. that blinding at the participant level is possible. This goal will be carried out in cooperation with the outpatient pharmacy unit and by the pharmacist. On the other hand, the coding is done by one of the colleagues of the project, and the doctor, evaluator, and patient are blind to how the patients are coded.

Only a part of the data, such as the information related to the main result or the like, can be shared.

The access period starts 6 months after the results are published

It will be available only to researchers working in academic and scientific institutions

Confirming the activities of researchers in academic and scientific institutions

Email to dramirheidari27@gmail.com Dr. Amir Heidari

The official data access request will be sent to the email sent after 6 months from the publication of the study and one month after the data request.