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Safety and efficacy of oral transmucosal fentanyl citrate for prehospital pain control on the battlefield

Wedmore, Ian S. MD; Kotwal, Russ S. MD, MPH; McManus, John G. MD; Pennardt, Andre MD; Talbot, Timothy S. MD; Fowler, Marcie PhD; McGhee, Laura PhD

Journal of Trauma and Acute Care Surgery: December 2012 - Volume 73 - Issue 6 - p S490–S495
doi: 10.1097/TA.0b013e3182754674
Original Articles

BACKGROUND Acute pain, resulting from trauma and other causes, is a common condition that imposes a need for prehospital analgesia on and off the battlefield. The narcotic most frequently used for prehospital analgesia on the battlefield during the past century has been morphine. Intramuscular morphine has a delayed onset of pain relief that is suboptimal and difficult to titrate. Although intravenously administered morphine can readily provide rapid and effective prehospital analgesia, oral transmucosal fentanyl citrate (OTFC) is a safe alternative that does not require intravenous access. This study evaluates the safety and efficacy of OTFC in the prehospital battlefield environment.

METHODS Data collected during combat deployments (Afghanistan and Iraq) from March 15, 2003, to March 31, 2010, were analyzed. Patients were US Army Special Operations Command casualties. Patients receiving OTFC for acute pain were evaluated. Pretreatment and posttreatment pain intensities were quantified by the verbal numeric rating scale (NRS) from 0 to 10. OTFC adverse effects and injuries treated were also evaluated.

RESULTS A total of 286 patients were administered OTFC, of whom 197 had NRS pain evaluations conducted before and approximately 15 minutes to 30 minutes following treatment. The difference between NRS pain scores at 0 minutes (NRS, 8.0 [1.4]) and 15 minutes to 30 minutes (NRS, 3.2 [2.1]) was significant (p < 0.001). Only 18.3% (36 of 197) of patients were also administered other types of analgesics. Nausea was the most common adverse effect as reported by 12.7% (25 of 197) of patients. The only major adverse effect occurred in the patient who received the largest opioid dose, 3,200-µg OTFC and 20-mg morphine. This patient exhibited hypoventilation and saturation of less than 90% requiring low-dose naloxone.

CONCLUSION OTFC is a rapid and noninvasive pain management strategy that provides safe and effective analgesia in the prehospital battlefield setting. OTFC has considerable implications for use in civilian prehospital and austere environments.

LEVEL OF EVIDENCE Therapeutic study, level IV.

From the US Army Austere and Wilderness Medicine Fellowship, Madigan Army Medical Center (I.S.W.), Joint Base Lewis-McChord, Washington; US Army Special Operations Command (R.S.K., A.P., T.S.T.), Fort Bragg, North Carolina; Emergency Medical Services (J.G.M.), Army Medical Department Center and School; and US Army Institute of Surgical Research (M.F., L.M.), Fort Sam Houston, Texas.

The authors have no relationships, financial or otherwise, that might be perceived as a conflict of interest. This article has been read and approved by all authors and all authors meet criteria for authorship. This article was prepared as part of official government duties. The views, opinions, and findings contained in this report are those of the authors and should not be construed as reflecting the views of the Department of the Army or the Department of Defense unless otherwise stated. This report was approved for public release by the US Army Special Operations Command Operational Security Office and the Public Affairs Office on May 4, 2011.

Address for reprints: Russ S. Kotwal, MD, MPH, US Army Special Operations Command, 2929 Desert Storm Dr, Fort Bragg, NC 28310; email:

© 2012 Lippincott Williams & Wilkins, Inc.