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 fieldduring cleft palate repair.
RCT Entities:
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.