Fentanyl is widely recognized as a highly potent and deadly street drug, accounting for countless overdose deaths in the ongoing opioid epidemic, but it does serve a medical purpose as a very effective emergency pain management medication for severely injured trauma patients. Benefits include relieving severe pain, but the drug can lower blood pressure and inhibit breathing reflexes leading to respiratory problems.
Researchers at the University of Pittsburgh are leading the Prehospital Analgesia INtervention (PAIN) Trial, to see if giving fentanyl or low dose ketamine to trauma patients with pain in mild shock affects health outcomes. The medication will be given in an ambulance on the way to the hospital. The 3-year, multi-center study beginning in the fall of 2022, will be led by principal investigators Dr. Frank Guyette, professor of emergency medicine and Dr. Jason Sperry, professor of surgery at Pitt, and UPMC trauma surgeon. It will assess if ketamine, an anesthetic that relieves pain without affecting breathing reflexes, can be a safer option for patients. The trial is part of the LITES Network which conducts research funded by the U.S. Department of Defense, to inform clinical practice guidelines and update the existing standards for the care of traumatic injuries.
“Most injuries are carefully treated with opioids, particularly with fentanyl. It is very important to control pain which is a great thing. It has side effects on blood pressure, which is important for a trauma patient and can worsen injury, and in rare cases it can cause hypotension, low oxygen levels, and respiratory issues which may require a breathing tube,” said Guyette.
Guyette said this problem is bigger in the military. Care may be delayed when someone experiences an injury requiring multiple doses of fentanyl.
“The goal is to help the military to provide the best care for injured personnel, help determine the best pain medicine and determine what are the best short and long-term outcomes when comparing these medications,” Sperry added.
The Pitt led study will enroll about 1200 random trauma patients (randomizing them to fentanyl or ketamine) from nine healthcare sites in the LITES Network in the United States.
“Both ketamine and fentanyl are used by Emergency Medical Services as standard treatment for pain management. Fentanyl is associated with addiction and low blood pressure. Ketamine may have some complications, including hallucinations, anxiety, and a feeling of disconnectedness, but may be more beneficial to some patients and lessen exposure and risks to opioids,” Sperry added.
Anyone may opt-out of the study by contacting the research team at 1-800-664-0557 or email PAINStudy@edc.pitt.edu to receive an opt out “NO PAIN Study” bracelet. For more information visit ClincialTrials.gov and refer to NCT05437575.Opting out will not prevent trauma patients from receiving pain medication, only from enrollment in the study.
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.
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