Effectiveness of tranexamic acid for reducing intraoperative bleeding in palatoplasties: A randomized clinical trial.

BACKGROUND: Few data are available regarding blood loss during cleft palate surgery. This study assessed the effect of using tranexamic acid in the reduction of intraoperative bleeding.

METHODS: A double-blind, randomized clinical trial compared intraoperative bleeding and the incidence of oronasal fistulas after palatoplasties in a control group that was given placebo and an intervention group that was given 10 mg/kg tranexamic acid followed by a continuous infusion of 1 mg/kg/h of the same until the end of surgery. Patients who underwent primary palatoplasty with no known or suspected coagulation disorders at our institution during the study period were included in the study.

RESULTS: 70 patients were allocated, 66 received the intervention. Blood loss was reduced by 11.9%, without statistical significance. The incidence of fistulas in the intervention and control groups was 12.9% and 18.75%, respectively. The reduction of 5.8% (CI 95%: 12%-23.8%) was not significant.

CONCLUSIONS: The reduction of intraoperative blood loss was lower than expected and not statistically significant; a larger sample is needed to confirm the observed reduction. The drug did not seem to have negative effects on flap viability.