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Early Versus Late(r) Administration of Intrapleural Fibrinolytic Therapy in Children with Empyema: A Systematic
Davinder Kaur1,2, Ketan Kumar3, Pravakar Mishra4,5
1Advanced Centre for Evidence Based Child Health, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.
Insights
No randomized controlled trials (RCTs) exist comparing early versus late intrapleural fibrinolytic therapy (IPFT) for childhood empyema. Further high-quality RCTs are needed to guide treatment decisions for pediatric empyema management.
Area of Science:
- Pediatric Pulmonology
- Thoracic Surgery
- Evidence-Based Medicine
Background:
- Intrapleural fibrinolytic therapy (IPFT) is common for empyema thoracis.
- Optimal timing for IPFT administration in pediatric empyema remains unclear.
Purpose of the Study:
- To compare early (within 24 hours) versus late (after 24 hours) IPFT in children with empyema.
- To inform evidence-based guideline recommendations for pediatric empyema treatment.
Main Methods:
- Systematic review of randomized controlled trials (RCTs) comparing early vs. late IPFT in children (<18 years).
- Searched multiple databases (PubMed, EMBASE, Cochrane, WOS, Scopus) and trial registries.
- Evaluated outcomes including treatment failure, clinical status, pulmonary function, adverse events, and cost.
Main Results:
- A comprehensive search identified 3,110 citations.
- No RCTs were found that directly addressed the research question on IPFT timing in pediatric empyema.
Conclusions:
- There is a significant lack of RCT evidence comparing early versus late IPFT in childhood empyema.
- Well-designed RCTs are essential to establish optimal timing for IPFT.
- Current evidence-based guidance requires additional considerations until RCT data becomes available.
Context:
Although intrapleural fibrinolytic therapy (IPFT) is frequently used in empyema thoracis, there is lack of clarity regarding the ideal timing of its administration.
Objective:
To synthesize evidence comparing early IPFT (i.e. at presentation, or as early as feasible, but within 24 h of confirmation of empyema), versus late(r) instillation (i.e. after 24 h of confirmation of empyema) in children with empyema, for the purpose of framing an evidence-based guideline recommendation.
Evidence Acquisition:
We searched for randomized controlled trials (RCTs) comparing early versus late(r) IPFT in children (< 18y) with confirmed empyema, through five databases of published literature viz. PubMed, EMBASE, the Cochrane Library, Web of Science (WOS), and Scopus, two grey literature databases (ProQuest and OpenGrey), and four clinical trial registries. There were no restrictions or filters used. A three-step approach was implemented to screen and select studies eligible for inclusion. The patient-centric outcomes evaluated were indicators of treatment failure, clinical outcomes, pulmonary function tests, adverse events and cost of therapy. We planned to calculate pooled odds ratios (OR), and mean differences (MDs) with 95% confidence intervals (CIs) for dichotomous and continuous outcomes respectively. The certainty of evidence was to be assessed using the GRADE approach.
Results:
The comprehensive search identified 3,110 citations, however there was no RCT addressing the review question.
Conclusions:
There are no RCTs comparing early versus late(r) use of fibrinolytic therapy in childhood empyema. Well-designed randomized controlled trials are required to address the question. Evidence-based guidance on the question must use additional considerations, until RCT evidence is available.
Trial Registration:
The protocol of the systematic review was registered in the PROSPERO database (ID: CRD42024516041) on March 03, 2024.
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