Efficacy of aprotinin in children undergoing craniofacial surgery

A prospective, randomized, placebo-controlled, double-blind trial was undertaken to assess the efficacy of aprotinin in 39 children (mean age 1.2 +/- 1.3 years) undergoing reconstructive craniofacial surgery. Two demographically similar groups were studied. Aprotinin (240mg/M-2/hr) was compared to an equal infusion of 0.9% saline(placebo). Patients in the aprotinin group received less blood per kilogram weight than the placebo patients (aprotinin 31+/- 25 mL/kg vs. placebo 51 +/- 34 mL/kg, P=0.04). Aprotinin patients had less change in their hematocrits during surgery (aprotinin -33 +/- 16% mL/kg vs placebo -43 +/- 9% mL/kg, P=0.01). The surgery faculty judged the blood loss in the aprotinin group as being significantly less than usual (P=0.03). Use of aprotinin was also associated with reduced blood transfusion requirements over the first 3 post-operative days (P=0.03). There were no adverse events reported in either the aprotinin or the placebo groups.