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

Cleft Palate Craniofac J. 2015 Sep;52(5):e183-7. doi: 10.1597/14-263. Epub 2014 Dec 22.

Abstract

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.

Keywords: cleft palate; palatoplasty; pediatric; satisfaction; surgical field; tranexamic acid.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Antifibrinolytic Agents / therapeutic use*
  • Blood Loss, Surgical / prevention & control*
  • Child, Preschool
  • Cleft Palate / surgery*
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Postoperative Hemorrhage / prevention & control*
  • Prospective Studies
  • Tranexamic Acid / therapeutic use*
  • Treatment Outcome

Substances

  • Antifibrinolytic Agents
  • Tranexamic Acid