JPS Health Network is participating in a national clinical trial aimed at improving how pain is managed for trauma patients in emergency situations, potentially reducing risks tied to opioid use in the field.
Led by researchers at the University of Pittsburgh, the Prehospital Analgesia INtervention (PAIN) Trial is a three-year, multi-center study comparing the effects of fentanyl and low-dose ketamine on patients experiencing mild shock from traumatic injuries. The medications will be administered by EMS personnel during ambulance transport, before patients reach the hospital.
This research is part of the LITES (Linking Investigations in Trauma and Emergency Services) Network, a US Department of Defense-supported initiative to inform clinical practice guidelines and improve standards of care for traumatic injuries in both civilian and military settings.
In Tarrant County, the study is being led by Angela Cornelius, MD, Associate Medical Director at JPS, a core faculty member in the JPS Emergency Medicine Department, and Associate EMS Medical Director for MedStar EMS.
“The PAIN study is crucial in advancing the understanding of optimal pain management strategies for trauma patients in the early time periods after a traumatic injury,” said Dr. Cornelius. “By evaluating the efficacy and safety of different pain control medications, this research helps to improve patient comfort, outcomes and overall trauma care.”
Fentanyl remains a critical tool for emergency pain relief but carries risks such as suppressed breathing and lowered blood pressure. Ketamine, already in use by EMS agencies, may provide comparable pain control while avoiding some of these complications.
“The PAIN study also extends beyond civilian trauma care into military medicine,” said Frank Guyette, MD, Professor of Emergency Medicine at the University of Pittsburgh and study co-lead. “The issue is even more critical in military settings, where care can be delayed if an injured service member requires multiple doses of fentanyl for pain management.”
“The goal is to help the military provide the best care for injured personnel, determine the most effective pain medication, and evaluate both the short- and long-term outcomes when comparing these medications,” added Jason Sperry, MD, study co-lead and Professor of Surgery at Pitt and trauma surgeon at UPMC.
About 1,200 trauma patients are expected to be enrolled nationwide at nine participating healthcare sites. Patients will be randomly assigned to receive either fentanyl or ketamine while in EMS care. The study builds on real-world protocols already used by first responders but aims to clarify when and for whom one medication may offer greater benefits.
Participation and opt out information
Because the trial takes place in emergency settings where patients may not be able to provide consent, it is being conducted under federal regulations that allow for exception from informed consent in specific circumstances.
Individuals who do not wish to participate may opt-out of the study in advance by requesting a free “NO PAIN Study” bracelet. To do so, contact the research team at 1-800-664-0557 or email PAINStudy@edc.pitt.edu. For more information visit www.clinicaltrials.gov and refer to NCT05437575. Opting out does not prevent trauma patients from receiving pain medication, it simply excludes them from being enrolled in the study.
Disclaimer: This research is supported by DoD contract W81XWH-16-D-0024 W81XWH-19-F-0539. Any opinions or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of the Department of Defense.
About JPS Health Network
The Tarrant County Hospital District, known as JPS Health Network, is a trusted healthcare leader in Tarrant County, delivering compassionate, high-quality care to all who need it, regardless of insurance status or ability to pay. With a 582-bed hospital, more than 25 community-based clinics, and a team of over 7,200 professionals, JPS provides comprehensive services that include trauma care, behavioral health, maternal and neonatal care, primary and specialty medicine, and more. As the region’s largest teaching institution and the most comprehensive provider of behavioral health services in the county, JPS stands at the intersection of access, innovation, and community trust. JPS is a three-time recipient of the Gallup Exceptional Workplace Award, a global recognition for organizations that foster extraordinary workplace engagement, innovation, and performance. Governed by an 11-member Board of Managers, JPS is committed to high-quality care, community well-being, and medical innovation.
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