Six Versus Three Doses of Intrapleural Streptokinase in Childhood Empyema: A Randomized Controlled Trial.

Abstract

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.