Six Versus Three Doses of Intrapleural Streptokinase in Childhood Empyema: A Randomized Controlled Trial
Chirag Thakur1, Joseph L Mathew1, Akshay K Saxena2
1Department of Pediatrics, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.
Insights
Administering six doses of intrapleural streptokinase (SK) for pediatric empyema is not more effective than three doses. This six-dose regimen is safe but does not improve treatment outcomes in children with empyema.
Area of Science:
- Pediatric Pulmonology
- Thoracic Surgery
- Infectious Diseases
Background:
- Empyema is a common pediatric thoracic infection.
- Intrapleural streptokinase (SK) is used to treat pediatric empyema.
- Optimal dosing regimens for intrapleural SK require further investigation.
Purpose of the Study:
- To compare the efficacy and safety of six doses versus three doses of intrapleural streptokinase (SK) in children with empyema.
- To evaluate if an extended SK regimen improves clinical outcomes and reduces treatment failure.
Main Methods:
- An open-label, placebo-controlled, randomized trial involving 53 children with empyema.
- Patients received an initial three doses of intrapleural SK.
- Non-responders or those with persistent fluid received three additional doses of SK or placebo.
Main Results:
- No statistically significant difference in cumulative pleural fluid drained between six-dose and three-dose SK groups.
- Similar outcomes in terms of intercostal drainage duration, time to clinical improvement, and hospitalization duration.
- No significant difference in treatment failure rates or adverse events between the groups.
Conclusions:
- Six doses of intrapleural streptokinase (SK) are not superior to three doses for treating pediatric empyema.
- The six-dose regimen is safe but does not offer additional therapeutic benefits.
- Current evidence suggests three doses of intrapleural SK are sufficient for pediatric empyema management.
Objective:
To compare the efficacy and safety of administering six doses of intrapleural streptokinase (SK) versus the conventional three doses, in children with empyema.
Study Design:
In this open label, placebo-controlled, randomized trial, we enrolled 53 children with empyema, who received three doses of intrapleural SK. Thereafter, those without clinical improvement (n = 34) and those showing clinical improvement but having persistent pleural fluid width > 10 mm on chest ultrasonography (n = 13), were randomized to receive three additional doses of SK, or three doses of placebo (normal saline). The remaining 6 children improved clinically and radiologically, hence were not randomized. The outcomes recorded were cumulative volume of pleural fluid drained, total duration of intercostal drainage, time taken for clinical improvement, duration of hospitalization, proportion of children with treatment failure requiring surgery, and adverse events. Spirometry, 6-min walk test, chest X-ray and ultrasonography were done 3 months following discharge. We analyzed by intention-to-treat.
Results:
The baseline characteristics of children who received six versus three doses SK were comparable. There was no statistically significant difference in the cumulative volume of fluid drained; median (IQR): 810.0 (330.0, 1630.0) [95% CI: 505, 1463] mL versus 530.0 (255.2, 1325.0) [95% CI: 325, 1131] mL, p 0.46. There were no significant inter-group differences in the total duration of intercostal drainage, time taken for clinical improvement, duration of hospitalization, treatment failure, surgical decortication and adverse events.
Conclusion:
In children with empyema, intrapleural therapy with six doses of SK is not superior to three doses, although it is safe.
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