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Safety of antifibrinolytics in 6583 pediatric patients having craniosynostosis surgery: A decade of data reported from the multicenter Pediatric Craniofacial Collaborative Group.

Publication ,  Journal Article
King, MR; Staffa, SJ; Stricker, PA; Pérez-Pradilla, C; Nelson, O; Benzon, HA; Goobie, SM; Pediatric Craniofacial Collaborative Group,
Published in: Paediatr Anaesth
December 2022

BACKGROUND: Antifibrinolytics such as tranexamic acid and epsilon-aminocaproic acid are effective at reducing blood loss and transfusion in pediatric patients having craniofacial surgery. The Pediatric Craniofacial Collaborative Group has previously reported low rates of seizures and thromboembolic events (equal to no antifibrinolytic given) in open craniofacial surgery. AIMS: To query the Pediatric Craniofacial Collaborative Group database to provide an updated antifibrinolytic safety profile in children given that antifibrinolytics have become recommended standard of care in this surgical population. Additionally, we include the population of younger infants having minimally invasive procedures. METHODS: Patients in the Pediatric Craniofacial Collaborative Group registry between June 2012 and March 2021 having open craniofacial surgery (fronto-orbital advancement, mid and posterior vault, total cranial vault remodeling, intracranial LeFort III monobloc), endoscopic cranial suture release, and spring mediated cranioplasty were included. The primary outcome is the rate of postoperative complications possibly attributable to antifibrinolytic use (seizures, seizure-like activity, and thromboembolic events) in infants and children undergoing craniosynostosis surgery who did or did not receive antifibrinolytics. RESULTS: Forty-five institutions reporting 6583 patients were included. The overall seizure rate was 0.24% (95% CI: 0.14, 0.39%), with 0.20% in the no Antifibrinolytic group and 0.26% in the combined Antifibrinolytic group, with no statistically reported difference. Comparing seizure rates between tranexamic acid (0.22%) and epsilon-aminocaproic acid (0.44%), there was no statistically significant difference (odds ratio = 2.0; 95% CI: 0.6, 6.7; p = .257). Seizure rate was higher in patients greater than 6 months (0.30% vs. 0.18%; p = .327), patients undergoing open procedures (0.30% vs. 0.06%; p = .141), and syndromic patients (0.70% vs. 0.19%; p = .009). CONCLUSIONS: This multicenter international experience of pediatric craniofacial surgery reports no increase in seizures or thromboembolic events in those that received antifibrinolytics (tranexamic acid and epsilon-aminocaproic acid) versus those that did not. This report provides further evidence of antifibrinolytic safety. We recommend following pharmacokinetic-based dosing guidelines for administration.

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Published In

Paediatr Anaesth

DOI

EISSN

1460-9592

Publication Date

December 2022

Volume

32

Issue

12

Start / End Page

1339 / 1346

Location

France

Related Subject Headings

  • Tranexamic Acid
  • Seizures
  • Infant
  • Humans
  • Craniosynostoses
  • Child
  • Blood Loss, Surgical
  • Antifibrinolytic Agents
  • Anesthesiology
  • Aminocaproic Acid
 

Citation

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King, M. R., Staffa, S. J., Stricker, P. A., Pérez-Pradilla, C., Nelson, O., Benzon, H. A., … Pediatric Craniofacial Collaborative Group, . (2022). Safety of antifibrinolytics in 6583 pediatric patients having craniosynostosis surgery: A decade of data reported from the multicenter Pediatric Craniofacial Collaborative Group. Paediatr Anaesth, 32(12), 1339–1346. https://doi.org/10.1111/pan.14540
King, Michael R., Steven J. Staffa, Paul A. Stricker, Carolina Pérez-Pradilla, Olivia Nelson, Hubert A. Benzon, Susan M. Goobie, and Susan M. Pediatric Craniofacial Collaborative Group. “Safety of antifibrinolytics in 6583 pediatric patients having craniosynostosis surgery: A decade of data reported from the multicenter Pediatric Craniofacial Collaborative Group.Paediatr Anaesth 32, no. 12 (December 2022): 1339–46. https://doi.org/10.1111/pan.14540.
King MR, Staffa SJ, Stricker PA, Pérez-Pradilla C, Nelson O, Benzon HA, et al. Safety of antifibrinolytics in 6583 pediatric patients having craniosynostosis surgery: A decade of data reported from the multicenter Pediatric Craniofacial Collaborative Group. Paediatr Anaesth. 2022 Dec;32(12):1339–46.
King, Michael R., et al. “Safety of antifibrinolytics in 6583 pediatric patients having craniosynostosis surgery: A decade of data reported from the multicenter Pediatric Craniofacial Collaborative Group.Paediatr Anaesth, vol. 32, no. 12, Dec. 2022, pp. 1339–46. Pubmed, doi:10.1111/pan.14540.
King MR, Staffa SJ, Stricker PA, Pérez-Pradilla C, Nelson O, Benzon HA, Goobie SM, Pediatric Craniofacial Collaborative Group. Safety of antifibrinolytics in 6583 pediatric patients having craniosynostosis surgery: A decade of data reported from the multicenter Pediatric Craniofacial Collaborative Group. Paediatr Anaesth. 2022 Dec;32(12):1339–1346.
Journal cover image

Published In

Paediatr Anaesth

DOI

EISSN

1460-9592

Publication Date

December 2022

Volume

32

Issue

12

Start / End Page

1339 / 1346

Location

France

Related Subject Headings

  • Tranexamic Acid
  • Seizures
  • Infant
  • Humans
  • Craniosynostoses
  • Child
  • Blood Loss, Surgical
  • Antifibrinolytic Agents
  • Anesthesiology
  • Aminocaproic Acid