SAFEKIDS Anesthesia

SAFEKIDS Anesthesia is a multi-year project to make anesthesia safer for children. There are suggestions from early research that some anesthetic drugs may be safer than others when administered to very young children, especially if they require repeated surgeries. Projects conducted under SAFEKIDS Anesthesia will study aspects of existing anesthetics and their administration (e.g. dosage, number of exposures) and inform research into new anesthetics and drugs currently in the development pipeline. Anesthesiology has long been the medical specialty that has led safety initiatives. SAFEKIDS Anesthesia is another example of that vision.

Background

Millions of children receive anesthesia each year. Non-clinical studies in juvenile animal models show that exposure to some anesthetics and sedatives is associated with memory and learning deficits and other neurodegenerative changes in the central nervous system. Insufficient human data exist to support or refute the possibility that similar effects could occur in children. To address the critical public health issues associated with the safe use of anesthesia and sedatives in young children, the Food and Drug Administration (FDA) and the International Anesthesia Research Society (IARS) are partnering together, and with multiple stakeholders (e.g. professional societies, academic research institutions, patient advocacy groups, industry and other government and nonprofit organizations) to launch the SAFEKIDS Public-Private Partnership, a multi-year, multi-phased collaborative effort to address major scientific and clinical gaps regarding the safe use of anesthetics and sedatives in children.

Current Research

In September 2008, the FDA awarded five contracts under the auspices of the SAFEKIDS initiative. These contract partners and objectives include:

  • Children's Hospital of Boston for a study on long-term neurodevelopmental outcomes in pediatric patients administered regional or general anesthesia as neonates or infants
  • Arkansas Children's Hospital Research Institute for a study on the pharmacokinetics, pharmacodynamics, and neurotoxic effects of an anesthetic in infants undergoing various surgical procedures
  • Columbia University for a study on the effects of anesthetic exposure on neurocognitive, emotional and behavioral outcomes
  • Mayo Clinic for a study on the long-term cognitive development following general anesthesia as an infant
  • The International Anesthesia Research Society (IARS) for leading the administrative oversight and managing the overarching framework for this Public-Private Partnership (hereafter referred to as the SAFEKIDS Initiative) under which expertise and resources will be leveraged from multiple stakeholders to support the scientific studies needed to bridge the aforementioned scientific gaps.

In addition, the FDA's National Center for Toxicology Research (NCTR) is conducting non-clinical studies in non-human primates to assess the mechanisms of neurotoxicity of clinically relevant sedatives such as ketamine, nitrous oxide and isoflurane and long-term developmental and learning effects related to exposure to these sedatives.

Under the framework of the SAFEKIDS Public-Private Partnership, the IARS and the FDA have developed the overarching infrastructure to implement and sustain additional pre-clinical and clinical research in this area, leveraging a combination of public and private resources and expertise to bridge the scientific and public health gaps in the pediatric population. Data, outcomes and best practices generated by SAFEKIDS Anesthesia will be placed in the public domain for the benefit of all stakeholders and patients.

For more information, contact safekids@iars.org