Corticosteroids as an Additional Treatment for Mastoiditis In Children (COSMIC)

ori snapiri

Status and phase: Not yet enrolling; Phase 3

Conditions: Mastoiditis; Acute

Treatments: Drug: Dexamethasone; Drug: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04828525

0702-20-RMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 6 months to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• acute mastoiditis

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

Experimental

Experimental group

Description:

participants will be given corticosteroids in addition to conventional treatment

Treatment:

Drug: Dexamethasone

Placebo

Placebo Comparator group

Description:

participants will be given normal saline in addition to conventional treatment

Treatment:

Drug: normal saline