1Department of Pediatrics, University Hospital Infanta Sofía, San Sebastián de los Reyes, Spain2Biomedical School, Universidad Europea, Madrid, Spain3Department of Pediatrics, University Hospital Ramón y Cajal, Madrid, Spain4Medical School, Universidad de Alcalá, Madrid, Spain5Pediatrics, Tropical and Infectious Diseases Department, University Hospital La Paz, Madrid, Spain6Pediatric Infectious Diseases Unit, University Hospital Gregorio Marañón, Madrid, Spain7Department of Pediatrics, Toledo University Hospital, Toledo, Castilla-La Mancha, Spain8Department of Pediatrics, Getafe University Hospital, Getafe, Spain9Department of Pediatrics, University Hospital Príncipe de Asturias, Alcalá de Henares, Madrid, Spain10Department of Pediatrics, University Hospital Carlos Haya, Málaga, Andalucía, Spain11Pediatric Infectious Diseases Unit, University Hospital 12 de Octubre, Madrid, Spain12Biostatistics Unit, University Hospital La Paz, Madrid, Spain
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ObjectiveTo assess whether dexamethasone (DXM) decreases the time to recovery in patients with parapneumonic pleural effusion.Study designThis was a multicenter, randomized, double blind, parallel-group, placebo-controlled clinical trial of 60 children, ranging in age from 1 month to 14 years, with community-acquired pneumonia (CAP) and pleural effusion. Patients received either intravenous DXM (0.25 mg/kg/dose) or placebo every 6 hours over a period of 48 hours, along with antibiotics. The primary endpoint was the time to recovery in hours, defined objectively. We also evaluated complications and adverse events.ResultsAmong the 60 randomized patients (mean age, 4.7 years; 58% female), 57 (95%) completed the study. Compared with placebo recipients, the patients receiving DXM had a shorter time to recovery, after adjustment by severity group and stratification by center (hazard ratio, 1.95; 95% CI, 1.10-3.45; P = .021). The median time to recovery for patients receiving DXM was 68 hours (2.8 days) shorter than patients receiving placebo (109 hours vs 177 hours; P = .037). In exploratory subgroup analysis, the median time to recovery for patients with simple effusion receiving DXM was 76 hours (3.1 days) shorter than for patients with simple effusion receiving placebo (P = .017). The median time to recovery for patients with complicated effusion receiving DXM was 14 hours (0.5 days) shorter than for patients with complicated effusion receiving placebo (P = .66). The difference in the effect of DXM in the 2 severity groups was not statistically significant (P = .138 for interaction). There were no significant differences in complications or adverse events attributable to the study drugs, except for hyperglycemia.ConclusionIn this trial, DXM seemed to be a safe and effective adjunctive therapy for parapneumonic pleural effusion.Trial registrationClinicalTrials.gov: NCT01261546.