Prehospital Analgesia INtervention Trial

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 Atrium Health Carolinas Medical Center F.H. Sammy Ross Trauma Center are collaborating with the University of Pittsburgh in 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 summer of 2024, will be led by principal investigator Dr. Addison May, a trauma surgeon. The trial 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.

The study will enroll about 1,000 random trauma patients (randomizing them to fentanyl or ketamine) from about 10 health care sites in the LITES Network in the United States.

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 ClinicalTrials.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.”