Low-dose tranexamic acid in orthognathic surgery: two-dose protocol-a double-blind randomized controlled trial on oedema, bleeding, and visibility of the surgical field.

Abstract

The aim of this double-blind randomized controlled trial was to evaluate the effects of a two-dose tranexamic acid (TXA) protocol on oedema, bleeding, and surgical field visibility during orthognathic surgery. 72 patients participated and were assigned to three groups: the TXA250 group received a single intravenous dose of 250 mg TXA prior to incision; the TXA500 group received 250 mg TXA before incision and 250 mg after the first jaw surgery was completed; the control group received no TXA. Oedema was measured preoperatively and on postoperative days 1, 3, and 7. Sixty-four patients completed the study. Bleeding was significantly higher and Fromme scale scores for surgical field visibility were significantly lower in the control group compared to the TXA groups (all P < 0.001). The TXA500 group demonstrated significantly reduced oedema compared to the control group (day 3: P = 0.037, day 7: P = 0.002), while the comparison of the TXA250 and control groups showed no significant difference. However, there was no significant difference in oedema between the two TXA groups. Hence, no firm conclusions can be drawn about the superiority of two-dose TXA over the single dose; this needs further investigation in a future study.