Details
Ketamine is a rapid-acting general anesthetic indicated for: (a) anesthesia for diagnostic and surgical procedures not requiring skeletal muscle relaxation, (b) induction of anesthesia prior to other general anesthetic agents, and (c) supplementation of other anesthetic agents. In August 2020, the Substance Abuse and Mental Health Administration (SAMHSA) inquired about the off-label use of ketamine for agitation by Emergency Medical Services (EMS) and in the emergency department (ED). In response, the U.S. Food and Drug Administration (FDA) initiated this study in the Sentinel System to understand the use of ketamine in EDs, by EMS, and in other pre-hospital settings, particularly for the treatment of agitation.
This study utilized the TriNetX USA Network Database, a Sentinel collaborator, which contained electronic medical records (EMR) from 67 healthcare organizations for approximately 90 million patients as of June 2020. The study population included unique patients with mental health diagnoses on the same day as, or the day following, an ED visit between January 1, 2016, and June 30, 2020. The study identified some use of ketamine in the defined population. In 2019, among 363,530 patients with a mental health diagnosis related to acute agitation on the day of an ED visit, less than 1% received ketamine (n=2,689 received any ketamine; n=865 received ketamine without a benzodiazepine or antipsychotic drug). While the available data suggested that ketamine may have been administered to help manage agitation, specific clinical reasons were difficult to determine due to data limitations.
This study supported the FDA’s broader efforts to monitor real-world drug utilization. Based on these Sentinel study findings, and information from other sources, no regulatory actions were recommended.