Corticosteroids as an Additional Treatment for Mastoiditis In Children

Study Overview
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Brief Summary
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The aim of the study is to assess the influence of adjuvant corticosteroid treatment in acute mastoiditis in children. we expect a better outcome in children treated with both corticosteroids and antibiotics including lower rates in complications and earlier decline in fever and inflammatory markers.

Detailed Description
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The research is a multi-centered, prospective, placebo-control, randomized controlled trial. The study group will be comprised of children diagnosed with acute mastoiditis and hospitalized in a pediatric medical center. The participating patients will be randomized divided into two groups. Research group will be given dexamethasone treatment (course of 16 doses, 0.15 mg/kg/dose every 6 hours) in addition to antibiotic treatment. Control group will be given 16 doses of 0.9% normal saline in addition to antibiotic treatment. Management and treatment will be conducted according to clinical condition and laboratory findings as for routine institution protocols. It should be noted that the regular institutional management of children enrolled for the study will not be changed due to our research.

Official Title
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Corticosteroids as an Additional Treatment for Mastoiditis In Children

Conditions
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Mastoiditis; Acute

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: acute mastoiditis Exclusion Criteria: immunodeficiency (congenital or acquired) significant chronic disease hypertension recurrent mastoiditis

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The research is a multi-centered, prospective, placebo-control, randomized controlled trial.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>participants will be given corticosteroids in addition to conventional treatment | Drug: Dexamethasone<br>* adjuvant dexamethasone treatment<br>|
| Placebo Comparator: Placebo<br>participants will be given normal saline in addition to conventional treatment | Drug: normal saline<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from the beginning of the treatment until clinical and laboratory findings are within normal limits | fever, crp levels | during hospitalization, anticipated 1-2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rates | sinus vein thrombosis, intracranial collection or abscess, need for surgery | during hospitalization, anticipated 1-2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mastoiditis, children, corticosteroids