Corticosteroids as an Additional Treatment for Mastoiditis In Children
NCT ID: NCT04828525
Last Updated: 2021-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
50 participants
INTERVENTIONAL
2021-04-01
2024-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Experimental
participants will be given corticosteroids in addition to conventional treatment
Dexamethasone
adjuvant dexamethasone treatment
Placebo
participants will be given normal saline in addition to conventional treatment
normal saline
placebo
Interventions
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Dexamethasone
adjuvant dexamethasone treatment
normal saline
placebo
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* significant chronic disease
* hypertension
* recurrent mastoiditis
6 Months
12 Years
ALL
Yes
Sponsors
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ori snapiri
OTHER
Responsible Party
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ori snapiri
Pediatrician, Principal Investigator, Clinical doctor
Central Contacts
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References
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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.
Other Identifiers
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0702-20-RMC
Identifier Type: -
Identifier Source: org_study_id
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