title: Dexamethasone for Parapneumonic Pleural Effusion: A Randomized, Double-Blind, Clinical Trial.
abstract: To assess whether dexamethasone (DXM) decreases the time to recovery in patients with parapneumonic pleural effusion.
  
  
  
  This 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.
  
  
  
  Among 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.
  
  
  
  In this trial, DXM seemed to be a safe and effective adjunctive therapy for parapneumonic pleural effusion.
  
  
  
  ClinicalTrials.gov: NCT01261546.
authors.affiliation: Department of Pediatrics, University Hospital Infanta Sofía, San Sebastián de los Reyes, Spain; Biomedical School, Universidad Europea, Madrid, Spain. Electronic address: alfredotagarro@hotmail.com.
authors.forename: Alfredo
authors.initials: A
authors.lastname: Tagarro
authors.affiliation: Department of Pediatrics, University Hospital Ramón y Cajal, Madrid, Spain; Medical School, Universidad de Alcalá, Madrid, Spain.
authors.forename: Enrique
authors.initials: E
authors.lastname: Otheo
authors.affiliation: Pediatrics, Tropical and Infectious Diseases Department, University Hospital La Paz, Madrid, Spain.
authors.forename: Fernando
authors.initials: F
authors.lastname: Baquero-Artigao
authors.affiliation: Pediatric Infectious Diseases Unit, University Hospital Gregorio Marañón, Madrid, Spain.
authors.forename: María-Luisa
authors.initials: ML
authors.lastname: Navarro
authors.affiliation: Department of Pediatrics, Toledo University Hospital, Toledo, Castilla-La Mancha, Spain.
authors.forename: Rosa
authors.initials: R
authors.lastname: Velasco
authors.affiliation: Department of Pediatrics, Getafe University Hospital, Getafe, Spain.
authors.forename: Marta
authors.initials: M
authors.lastname: Ruiz
authors.affiliation: Department of Pediatrics, University Hospital Príncipe de Asturias, Alcalá de Henares, Madrid, Spain.
authors.forename: María
authors.initials: M
authors.lastname: Penín
authors.affiliation: Department of Pediatrics, University Hospital Carlos Haya, Málaga, Andalucía, Spain.
authors.forename: David
authors.initials: D
authors.lastname: Moreno
authors.affiliation: Pediatric Infectious Diseases Unit, University Hospital 12 de Octubre, Madrid, Spain.
authors.forename: Pablo
authors.initials: P
authors.lastname: Rojo
authors.affiliation: Biostatistics Unit, University Hospital La Paz, Madrid, Spain.
authors.forename: Rosario
authors.initials: R
authors.lastname: Madero
mesh_terms: D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D002097:C-Reactive Protein / Q000032:analysis; D002675:Child, Preschool; D017714:Community-Acquired Infections / Q000188:drug therapy; D003907:Dexamethasone / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005938:Glucocorticoids / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D010996:Pleural Effusion / Q000188:drug therapy*; D011014:Pneumonia / Q000188:drug therapy; D016016:Proportional Hazards Models; D020127:Recovery of Function; D013997:Time Factors
chemical_list: D000900:Anti-Bacterial Agents; D005938:Glucocorticoids; D003907:Dexamethasone; D002097:C-Reactive Protein
keywords: corticoids; corticosteroids; parapneumonic effusion; pneumonia