The Pediatric Craniofacial Collaborative Group (PCCG) Consensus Conference Methodology.

OBJECTIVE: This article describes the methodology used for the Pediatric Craniofacial Collaborative Group (PCCG) Consensus Conference. DESIGN: This is a novel Consensus Conference of national experts in Pediatric Craniofacial Surgery and Anesthesia, who will follow standards set by the Institute of Medicine and using the Research and Development/University of California, Los Angeles appropriateness method, modeled after the Pediatric Critical Care Transfusion and Anemia Expertise Initiative. Topics related to pediatric craniofacial anesthesia for open cranial vault surgery were divided into twelve subgroups with a systematic review of the literature. SETTING: A group of 20 content experts met virtually between 2019 and 2020 and will collaborate in their selected topics related to perioperative management for pediatric open cranial vault surgery for craniosynostosis. These groups will also identify where future research is needed. CONCLUSIONS: Experts in pediatric craniofacial surgery and anesthesiology are developing recommendations on behalf of the Pediatric Craniofacial Collaborative Group for perioperative management of patients undergoing open cranial vault surgery for craniosynostosis and identifying future research priorities.

Behind the Black Box: The Evidence for the U.S. Food and Drug Administration Warning about the Risk of General Anesthesia in Children Younger than 3 Years.

On December 14, 2016, the U.S. Food and Drug Administration issued a Drug Safety Communication warning "that repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than 3 years or in pregnant women during their third trimester may affect the development of children's brains." Health care professionals were urged to "balance the benefits of appropriate anesthesia in young children and pregnant women against the potential risks, especially for procedures that may last more than 3 hours or if multiple procedures are required in children under 3 years." Surgeons must have an understanding of the evidence that led to the U.S. Food and Drug Administration warning and recommendations to appropriately weigh these risks and counsel their patients. In this article, the authors summarize the preclinical and clinical data that led to the U.S. Food and Drug Administration warning, discuss ongoing clinical studies, and provide strategies to reduce the risk of general anesthesia in patients younger than 3 years.