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

Abstract 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 or...

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Bibliographic Details
Published in:Journal of cranio-maxillo-facial surgery 2017-05, Vol.45 (5), p.642-648
Main Authors: Arantes, Guilherme C, Pereira, Rui Manoel R, de Melo, Daniela B, Alonso, Nivaldo, Duarte, Maria do Carmo M.B
Format: Article
Language:English
Subjects:
Adolescent
Antifibrinolytic Agents - therapeutic use
Blood loss
Blood Loss, Surgical - prevention & control
Child
Child, Preschool
Cleft palate
Cleft Palate - surgery
Dentistry
Double-Blind Method
Female
Humans
Infant
Male
Palate - surgery
Surgery
Tranexamic acid
Tranexamic Acid - therapeutic use
Young Adult
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Summary:Abstract 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.
ISSN:1010-5182
1878-4119
DOI:10.1016/j.jcms.2016.12.021