When Time Counts Rely on Teleflex

The current Tactical Combat Casualty Care (TCCC) Guidelines recommend parenteral promethazine as the single agent for the treatment of opioid-induced nausea and/or vomiting and give a secondary indication of “synergistic analgesic effect.” Promethazine, however, has a well-documented history of undesired side effects relating to impairment and dysregulation of the central and autonomic nervous systems, such as sedation, extrapyramidal symptoms, dystonia, impairment of psychomotor function, neuroleptic malignant syndrome, and hypotension. These may be particularly worrisome in the combat casualty. Additionally, since 16 September 2009, there has been a US Food and Drug Administration (FDA) black box warning for the injectable form of promethazine, due to “the risk of serious tissue injury when this drug is administered incorrectly.” Conversely, ondansetron, which is now available in generic form, has a well-established favorable safety profile and demonstrated efficacy in undifferentiated nausea and vomiting in the emergency department and prehospital settings. It has none of the central and autonomic nervous system side effects noted with promethazine and carries no FDA black box warning. Ondansetron is available in parenteral form and an orally disintegrating tablet, providing multiple safe and effective routes of administration. Despite the fact that it is an off-label use, ondansetron is being increasingly given for acute, undifferentiated nausea and vomiting and is presently being used in the field on combat casualties by some US and Allied Forces. Considering the risks involved with promethazine use, and the efficacy and safety of ondansetron and ondansetron’s availability in a generic form, we recommend removing promethazine from the TCCC Guidelines and replacing it with ondansetron. Proximate Cause for the Proposed Change The current Tactical Combat Casualty Care (TCCC) Guidelines recommend parenteral promethazine as the single agent for the treatment of opioid-induced nausea and vomiting, and note a secondary “synergistic analgesic effect.” These are current and historically frequent uses of promethazine; however, there is now a significant amount of evidence and experience to indicate that it should not be the preferred agent for either indication, particularly in the combat trauma patient.1 The original selection of promethazine over ondansetron for the TCCC Guidelines was made at a time when ondansetron was still being sold under patent. Generic forms of the drug were not available and Zofran (ondansetron; GlaxoSmithKline plc; www.gsk.com) was prohibitively expensive for use as a battlefield antiemetic. Ondansetron is an antiemetic that is increasingly being used as the agent of choice in the treatment of nausea and vomiting in the emergency department (ED)2 and the prehospital environment,3 as well as the inpatient, obstetrical, and surgical settings. Although FDA approved for use in nausea associated with chemotherapy and ionizing radiation for cancer treatment and for postoperative nausea, there is an extensive body of literature describing the safe and effective use of ondansetron in many other scenarios, including undifferentiated nausea in the ED.4 It has a well-established record of both efficacy and safety and a mild side effect profile that make it a much better choice than promethazine for use on the battlefield and in the tactical care environment. Considering the safety and effectiveness of ondansetron and the risks of promethazine, we propose to remove