Evaluation of the Efficacy of Tranexamic Acid on the Surgical Field in Primary Cleft Palate Surgery on Children-A Prospective, Randomized Clinical Study

Objective: To assess the effect of tranexamic acid on the quality of the surgical field. Design: Prospective, randomized, double-blind study. Setting: Institutional, tertiary referral hospital. Participants: American Society of Anesthesiologists physical status class I patients, aged 8 to 60 months with Group II or III (Balakrishnan's classification) clefts scheduled for cleft palate repair. Interventions: Children were randomized into two groups. The control group received saline, and the tranexamic acid group received tranexamic acid 10 mg/kg as a bolus, 15 minutes before incision. Main Outcome Measures: Grade of surgical field on a 10-point scale, surgeon satisfaction, and primary hemorrhage. Results: Significant improvements were noted in surgeon satisfaction and median grade of assessment of the surgical field (4 [interquartile range, 4 to 6] in the control group vs. 3 [interquartile range, 2 to 4] in the test group; P = .003) in the tranexamic acid group compared to the control group. Conclusion: Preincision administration of 10 mg/kg of tranexamic acid significantly improved the surgical field during cleft palate repair.