Dexamethasone for Parapneumonic Pleural Effusion: A Randomized, Double-Blind, Clinical Trial

J Pediatr. 2017 Jun:185:117-123.e6. doi: 10.1016/j.jpeds.2017.02.043. Epub 2017 Mar 28.

Abstract

Objective: To assess whether dexamethasone (DXM) decreases the time to recovery in patients with parapneumonic pleural effusion.

Study design: 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.

Results: 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.

Conclusion: In this trial, DXM seemed to be a safe and effective adjunctive therapy for parapneumonic pleural effusion.

Trial registration: ClinicalTrials.gov: NCT01261546.

Keywords: corticoids; corticosteroids; parapneumonic effusion; pneumonia.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Anti-Bacterial Agents / therapeutic use
  • C-Reactive Protein / analysis
  • Child, Preschool
  • Community-Acquired Infections / drug therapy
  • Dexamethasone / therapeutic use*
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Glucocorticoids / therapeutic use*
  • Humans
  • Male
  • Pleural Effusion / drug therapy*
  • Pneumonia / drug therapy
  • Proportional Hazards Models
  • Recovery of Function
  • Time Factors

Substances

  • Anti-Bacterial Agents
  • Glucocorticoids
  • Dexamethasone
  • C-Reactive Protein

Associated data

  • ClinicalTrials.gov/NCT01261546