Comparison of Six versus Three Doses of Intrapleural Fibrinolytic Therapy in Children with Empyema: A Randomized Controlled Trial.

Objectives: To compare six doses of intrapleural streptokinase (SK) vs. the conventional three doses in children with empyema.

Methods: In this randomized controlled trial, children with empyema received intrapleural streptokinase, either twice daily for 3 d (total 6 doses); or once daily for 3 d (total 3 doses). The outcomes assessed were treatment failure, volume of fluid drained, duration of fever, duration of respiratory distress, length of hospitalization, need for surgical decortication, adverse events and cost.

Results: Thirty-six children were enrolled. Cumulative pleural pus drainage was significantly higher with six doses [median (IQR) 367 (266, 850) vs. 195 (142, 422) ml, p 0.02]. The mean (SD) durations of fever and respiratory distress, after completing intrapleural therapy were also shorter; 2.3 (0.8) vs. 5.7 (1.6) d, p 0.04; and 2.2 (0.9) vs. 6.3 (1.9) d, p 0.03 respectively. However, there were no statistically significant differences in the length of hospitalization after completing therapy [median (IQR) 9 (6, 17) vs. 12 (4, 16) d], total duration of intercostal drainage [median (IQR) 13 (11, 21) vs. 12 (7, 19) d], treatment failure rate [4/16 (25%) vs. 7/16 (43.7%)], or need for surgical decortication [2/16 (16.2%) vs. 1/16 (6.2%)]. There were no significant adverse effects necessitating cessation or modification of therapy in either group. The cost of therapy was identical in both groups.

Conclusions: Six doses of intrapleural streptokinase appear superior to the conventional three doses in children with empyema, with comparable safety and cost.