The aim of this study is to evaluate the efficacy of addition of corticosteroid therapy to antibiotic treatment during the first 48 hours of admission to the hospital in patients with cellulitis and its impact in the duration of the stay.
Cellulitis is a common skin and soft tissue infection in the pediatric population. Although most of the time treatment could be administered on an ambulatory setting , sometimes it may require hospitalization and parenteral antibiotic administration. Using corticosteroids during antibiotic treatment may reduce inflammation and length of stay. Objective: to evaluate the efficacy of using corticosteroids as adjuvant treatment during the first 48 hours of treatment after hospitalization in patients with cellulitis. Patients and methods: this is a double blind, randomized, controlled trial that will take place at pediatric hospital, during one year. It will include children aged 1 month to 18 years, admitted due to cellulitis. Once included in the clinical trial, the patients will be randomized to receive dexamethasone 0,6 mg/kg/day or placebo (saline solution) during the first 48 hours. Considering an average stay of 4 ± 2 days, we calculated a sample size of 124 children (62 children per group) to detect a 25% difference (1 day reduction) in the length of stay, with a power of 80% and a confidence of 95%.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
19
IV Dexamethasone 0.15 mg/kg every 6 hours for 48 hours
IV normal saline every 6 hours for 48 hours
Hospital General de NIños Pedro de Elizalde
Buenos Aires, Buenos Aires F.D., Argentina
Length of stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 days
Fever duration
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 days
Change in erythema size
Time frame: Measured at admission and after 48 hours (at the end of corticosteroids treatment)
Need to change antibiotic treatment
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 days
Abscessation or spontaneous drainage
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 days
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