Corticosteroids as an Additional Treatment for Mastoiditis In Children

Phase 3

• Conditions: Mastoiditis; Acute
• Interventions: Drug: normal saline; Drug: Dexamethasone

• Registration Number: NCT04828525
• Lead Sponsor: ori snapiri

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2021-03-30
• Study First Submitted QC: 2021-03-30
• Status Verified: 2021-04
• Study Start: 2021-04-01
• Study First Posted: 2021-04-02
• Last Update Submitted: 2021-04-04
• Last Update Posted: 2021-04-06
• Primary Completion: 2024-03-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• acute mastoiditis

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Exclusion Criteria

• immunodeficiency (congenital or acquired)
• significant chronic disease
• hypertension
• recurrent mastoiditis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	normal saline	participants will be given normal saline in addition to conventional treatment
Experimental	Dexamethasone	participants will be given corticosteroids in addition to conventional treatment

Primary Outcome Measures

Name	Time	Method
Time from the beginning of the treatment until clinical and laboratory findings are within normal limits	during hospitalization, anticipated 1-2 weeks	fever, crp levels

Secondary Outcome Measures

Name	Time	Method
Complication rates	during hospitalization, anticipated 1-2 weeks	sinus vein thrombosis, intracranial collection or abscess, need for surgery