Journal
JOURNAL OF CRANIO-MAXILLOFACIAL SURGERY
Volume 45, Issue 5, Pages 642-648Publisher
CHURCHILL LIVINGSTONE
DOI: 10.1016/j.jcms.2016.12.021
Keywords
Cleft palate; Blood loss; Tranexamic acid
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Funding
- Facial Defects Awareness Center of the Professor Fernando Figueira Integral Medicine Institute (Centro de Atencao aos Defeitos da Face do Instituto de Medicina Integral Prof. Fernando Figueirae- CADEFI)
- Brazilian Unified Health System (Sistema Unico de Saude - SUS)
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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% (Cl 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. (C) 2016 Published by Elsevier Ltd on behalf of European Association for Cranio-Maxillo-Facial Surgery.
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