Effectiveness of tranexamic acid on intraoperative blood loss in isolated Le Fort I osteotomies--a prospective, triple blinded randomized clinical trial.

The aim of this triple blinded randomized clinical trial was to evaluate the efficacy of tranexamic acid when used in conjunction with hypotensive anaesthesia exclusively for Le Fort I osteotomies. 49 patients undergoing Le Fort I osteotomy for correction of dentofacial deformity were divided into two groups; Group 1 received a placebo of saline 5 ml and Group 2 received 10 mg/kg body weight of tranexamic acid. The operating surgeon, anaesthetist and investigator were blinded. The variables of interest recorded in this study included the change in Hb%, PCV, total blood loss, total operating time and quality of the surgical field using Fromme's Ordinal Scale. Statistically significant differences between the two groups were found between the following variables: post-operative Hb%, drop in Hb%, post-operative PCV, drop in PCV, total surgical blood loss, total operating time and quality of surgical field (P < 0.05). Group 2 patients exhibited a smaller drop in Hb% and PCV, with a lower Fromme's Ordinal Scale value and decreased total blood loss and operating time. In conclusion single preoperative administration of tranexamic acid in the dose of 10 mg/kg, when combined with hypotensive anaesthesia is effective in controlling blood loss with regards to single piece Le Fort I surgery.