When a person in the U.S. suffers a traumatic injury, emergency responders commonly give them one of two pain medications: fentanyl, an opioid; or ketamine, an anesthetic. Both medications reduce severe pain, but physicians aren’t sure which one works better. Both also come with potentially harmful side effects that may continue after treatment has ended.
A research study involving pre-hospital ambulance services and led by the UVM Medical Center will compare the effectiveness and safety of fentanyl and ketamine. Daniel Wolfson, M.D., M.S., associate professor of emergency medicine at the University of Vermont Larner College of Medicine and the state’s EMS medical director, and Ajai Malhotra, M.D., professor of surgery at the Larner College of Medicine and trauma medical director of the Level- I Trauma Center at the UVM Medical Center, are leading the study.
UVM is one of 12 locations across the country participating in this study, which will enroll about 1,000 injured patients from large academic medical centers in the U.S. and train emergency medical services (EMS) responders to enroll patients. It is one of a series of studies funded by the U.S. Department of Defense (DoD) to inform clinical practice guidelines and update the existing standards for the care of traumatic injuries. The findings will benefit soldiers and civilians alike.
“Fentanyl is commonly used to treat pain in trauma patients but can lower oxygen levels and blood pressure, potentially worsening an injured person’s condition and sometimes requiring a breathing tube. T; there’s also a risk of long-term opioid dependency. Low-dose ketamine is effective in managing pain and may reduce the risks associated with opioids, but it may cause side effects, such as hallucinations, anxiety, and a feeling of being disconnected,” says Wolfson. “Both ketamine and fentanyl are already used by emergency medical services in Vermont as standard treatment for pain management. This study will help us identify which medication provides the best care while minimizing risks.”
“Both ketamine and fentanyl are already used by emergency medical services in Vermont as standard treatment for pain management. This study will help us identify which medication provides the best care while minimizing risks.” — Daniel Wolfson, M.D., M.S.
For the DoD, the goals are to “help the military provide the best care for our injured personnel, by determining the most effective medicine to relieve the pain and also the one with the least harmful short- and long-term side effects,” says Malhotra. Many military service members returning from deployment experience pain, post-traumatic stress disorders, and substance abuse, and the DoD recognizes a need to manage pain and reduce the hazards of associated with pain medications. While the primary aim of the DoD is focused on service personnel, the results will benefit the civilian population, as well.
The enrolled patients will include people who experience a painful traumatic injury and are being transported to the UVM Medical Center by a participating ambulance service. They will be randomized to receive either fentanyl or low-dose ketamine for pain relief. All enrolled patients will be carefully monitored for both for effectiveness of pain relief and for short- and long-term complications. Because this study involves patients in shock and severe pain from a traumatic injury, there is not time to engage them in a lengthy informed consent process, explains Alex Naumann, the UVM site research coordinator and a local paramedic. Anyone may opt-out of the study in advance by contacting the research team by telephone at 1-800-664-0557 or via email to PAINStudy@edc.pitt.edu PAINStudy@edc.pitt.edu to receive an opt out “NO PAIN Study” bracelet. Opting out will not prevent injured patients from receiving pain medication as per standard of care, only from enrollment in the study.
“The paramedic will say something along the lines of, ‘We're We’re going going to give you some pain medication now, it's it’s going to be either ketamine or fentanyl.’ If a patient or family member expresses that the patient does not wish to receive one of those medications or the patient is wearing a NO PAIN Study bracelet, they would not be enrolled in the study and would be given pain medication from our standard treatment,” which would likely include either ketamine or fentanyl, Nauman says.
The funding for this study is broken up into various milestones. To date, UVM has received $30,000, not including $70k 70,000 devoted specifically to the training of EMS providers about how to enroll patients in this study. The study is expected to run until 1,000 patients nationwide are enrolled, which will likely take three to five years, Nauman saidsays.
The research team encourages community members to share their thoughts about this research project in a survey. The survey will help the team assess community members’ understanding and feelings about the study.
Research like this has contributed to the University of Vermont’s designation by the Carnegie Classification of Institutions of Higher Education as an R1 institution, placing it in the top tier of research universities in the U.S.
