Mastoiditis; Acute
Conditions
Keywords
mastoiditis, children, corticosteroids
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.
Interventions
DRUGDexamethasone
adjuvant dexamethasone treatment
DRUGnormal saline
placebo
Sponsors
ori snapiri
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
participants will be randomized divided into two groups. each group will be given dexamethasone or 0.9% normal saline. only the pharmacist will not be masked to the procedure.
Intervention model description
The research is a multi-centered, prospective, placebo-control, randomized controlled trial.
Eligibility
Sex/Gender
ALL
Age
6 Months to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* acute mastoiditis
Exclusion criteria
* immunodeficiency (congenital or acquired) * significant chronic disease * hypertension * recurrent mastoiditis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Complication rates | during hospitalization, anticipated 1-2 weeks | sinus vein thrombosis, intracranial collection or abscess, need for surgery |
Other
| Measure | Time frame | Description |
|---|---|---|
| Duration of hospitalization | anticipated 1-2 weeks | time from admission until discharge |
Contacts
Primary ContactOri Snapiri, Dr
Backup ContactChen Rosenberg Danziger, Dr
Outcome results
None listed