Page 27 - Journal of Special Operations Medicine - Summer 2015

Replacement of Promethazine With Ondansetron for
WHEN TIME COUNTS Treatment of Opioid- and Trauma-Related Nausea and Vomiting

RELY ON TELEFLEX. T.A.L.O.N. 7-SITE TACTICAL ADVANTAGE in Tactical Combat Casualty Care
™
NEEDLE SET
When faced with difficult vascular access, our TCCC Guidelines: Proposed Change 14-03
Military-use solutions provide pre-hospital NSN: 6515-01-626-6395
providers the opportunity to impact lives.
Dana J. Onifer, MD; Frank K. Butler, MD; Kirby R. Gross, MD; Edward J. Otten, MD;
The EZ-IO T.A.L.O.N. Needle Set and the T.A.L.O.N. ™ Robert Patton, MD; Robert J. Russell, MD; Zsolt Stockinger, MD; Elizabeth Burrell
®
™
Needle Set
Arrow EZ-IO Intraosseous Vascular Access
®
®
System offer users an intraosseous (IO) vascular EZ-Connect ®
Extension Set
access solution for rapid medication and fluid Sternal
Locator
delivery during casualty resuscitation.
ABSTRACT
The current Tactical Combat Casualty Care (TCCC) Proximate Cause for the Proposed Change
Guidelines recommend parenteral promethazine as the The current Tactical Combat Casualty Care (TCCC)
single agent for the treatment of opioid-induced nau-
• LIFE-SAVING: Delivers fluids and medications Guidelines recommend parenteral promethazine as the
rapidly for casualty resuscitation sea and/or vomiting and give a secondary indication of single agent for the treatment of opioid-induced nausea
“synergistic analgesic effect.” Promethazine, however,
• SIMPLE: Designed for any level responder has a well-documented history of undesired side effects and vomiting, and note a secondary “synergistic analge-
relating to impairment and dysregulation of the central sic effect.” These are current and historically frequent
uses of promethazine; however, there is now a signifi-
and autonomic nervous systems, such as sedation, ex- cant amount of evidence and experience to indicate that
trapyramidal symptoms, dystonia, impairment of psy- it should not be the preferred agent for either indication,
chomotor function, neuroleptic malignant syndrome,
EZ-IO INTRAOSSEOUS VASCULAR ACCESS and hypotension. These may be particularly worrisome particularly in the combat trauma patient. 1
®
SYSTEM FOR MILITARY USE in the combat casualty. Additionally, since 16 Septem- The original selection of promethazine over ondanse-
EZ-IO ® ber 2009, there has been a US Food and Drug Admin- tron for the TCCC Guidelines was made at a time when
Power Driver istration (FDA) black box warning for the injectable ondansetron was still being sold under patent. Generic
form of promethazine, due to “the risk of serious tis- forms of the drug were not available and Zofran (ondan-
sue injury when this drug is administered incorrectly.” setron; GlaxoSmithKline plc; www.gsk.com) was pro-
EZ-Stabilizer ® Conversely, ondansetron, which is now available in hibitively expensive for use as a battlefield antiemetic.
Dressing generic form, has a well-established favorable safety
profile and demonstrated efficacy in undifferentiated Ondansetron is an antiemetic that is increasingly being
PROXIMAL HUMERUS nausea and vomiting in the emergency department and used as the agent of choice in the treatment of nausea
prehospital settings. It has none of the central and au- and vomiting in the emergency department (ED) and
2
STERNUM 45 mm tonomic nervous system side effects noted with pro- the prehospital environment, as well as the inpatient,
3
25 mm EZ-Connect ® methazine and carries no FDA black box warning. obstetrical, and surgical settings. Although FDA ap-
PROXIMAL TIBIA EZ-IO ® Extension Set
Needle Sets Ondansetron is available in parenteral form and an proved for use in nausea associated with chemotherapy
DISTAL TIBIA orally disintegrating tablet, providing multiple safe and and ionizing radiation for cancer treatment and for post-
effective routes of administration. Despite the fact that operative nausea, there is an extensive body of literature
it is an off-label use, ondansetron is being increasingly describing the safe and effective use of ondansetron in
given for acute, undifferentiated nausea and vomiting many other scenarios, including undifferentiated nausea
and is presently being used in the field on combat ca- in the ED. It has a well-established record of both ef-
4
TELEFLEX.COM/MILITARY sualties by some US and Allied Forces. Considering the ficacy and safety and a mild side effect profile that make
risks involved with promethazine use, and the efficacy it a much better choice than promethazine for use on the
and safety of ondansetron and ondansetron’s availabil- battlefield and in the tactical care environment.
Product of the U.S.A. Potential complications may include local or systemic infection, hematoma, extravasations or other complications associated with percutaneous insertion of sterile devices. ity in a generic form, we recommend removing pro-
Teleflex, Arrow, EZ-Connect, EZ-IO, EZ-Stabilier and T.A.L.O.N. are trademarks or registered trademarks of Teleflex Incorporated or its affiliates. Considering the safety and effectiveness of ondansetron
© 2015 Teleflex Incorporated. All rights reserved. MC-000955 Rev 1 methazine from the TCCC Guidelines and replacing it
with ondansetron. and the risks of promethazine, we propose to remove

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