Corticosteroids as an Additional Treatment for Mastoiditis In Children

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: March 31, 2024

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

  • Drug: Dexamethasone
    • adjuvant dexamethasone treatment
  • Drug: normal saline
    • placebo

Arms, Groups and Cohorts

  • Experimental: Experimental
    • participants will be given corticosteroids in addition to conventional treatment
  • Placebo Comparator: Placebo
    • participants will be given normal saline in addition to conventional treatment

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

  • acute mastoiditis Exclusion Criteria:

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

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • ori snapiri
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: ori snapiri, Pediatrician, Principal Investigator, Clinical doctor – Rabin Medical Center
  • Overall Contact(s)
    • Ori Snapiri, Dr, +972547242654, orisnapiri@gmail.com

References

Lin HW, Shargorodsky J, Gopen Q. Clinical strategies for the management of acute mastoiditis in the pediatric population. Clin Pediatr (Phila). 2010 Feb;49(2):110-5. doi: 10.1177/0009922809344349. Epub 2009 Sep 4.

Groth A, Enoksson F, Hultcrantz M, Stalfors J, Stenfeldt K, Hermansson A. Acute mastoiditis in children aged 0-16 years–a national study of 678 cases in Sweden comparing different age groups. Int J Pediatr Otorhinolaryngol. 2012 Oct;76(10):1494-500. doi: 10.1016/j.ijporl.2012.07.002. Epub 2012 Jul 23.

Delgado-Noguera MF, Forero Delgadillo JM, Franco AA, Vazquez JC, Calvache JA. Corticosteroids for septic arthritis in children. Cochrane Database Syst Rev. 2018 Nov 21;11(11):CD012125. doi: 10.1002/14651858.CD012125.pub2.

Aljebab F, Choonara I, Conroy S. Systematic review of the toxicity of short-course oral corticosteroids in children. Arch Dis Child. 2016 Apr;101(4):365-70. doi: 10.1136/archdischild-2015-309522. Epub 2016 Jan 14.

Brouwer MC, McIntyre P, Prasad K, van de Beek D. Corticosteroids for acute bacterial meningitis. Cochrane Database Syst Rev. 2015 Sep 12;2015(9):CD004405. doi: 10.1002/14651858.CD004405.pub5.

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