Doctors at Cooper University Health Care are participating in a Department of Defense-funded study that seeks to improve the survival rate of severely injured patients. Prehospital Analgesia INtervention Trial, or PAIN, is a nationwide, phase-3, prehospital clinical trial being led by the University of Pittsburgh that aims to compare the effect of two intravenous (IV) pain medications administered to severely injured patients in the prehospital course of treatment.
The PAIN Trial will investigate whether giving fentanyl or a 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.
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; however, the drug can lower blood pressure and inhibit breathing reflexes leading to respiratory problems. Unfortunately, it is used as the standard for pain management of patients who sustain injuries. The study will assess if ketamine, an anesthetic that relieves pain without affecting breathing reflexes, can be a safer option for patients.
“Both ketamine and fentanyl are used routinely by emergency medical services as standard treatment for injured patients. Fentanyl has adverse effects including lowering blood pressure and respiratory drive. Ketamine may be more beneficial to some patients and lessen the risks associated with fentanyl,” said Tanya Egodage, MD, a trauma surgeon at Cooper and Assistant Professor of Surgery at Cooper Medical School of Rowan University, who will serve as the Principal Investigator for Cooper’s participation in the study.
The trial is part of the LITES Network which conducts research funded by the US Department of Defense, to inform clinical practice guidelines and update the existing standards for the care of traumatic injuries.
PAIN is being conducted under Exception from Informed Consent (EFIC) for emergency research rules. This means that since the trial requires performing a potentially life-saving procedure in people who are too injured to give permission, patients who have a traumatic injury, are in shock, and need treatment for their pain will be enrolled. Permission for continued participation will be obtained from patients once they improve, or from their family members, as soon as possible.
To be eligible for enrollment, patients must be transported by EMS directly from the scene of injury to Cooper University Hospital as a trauma activation and meet the following general enrollment criteria:
- Males 18 years or older and females 50 years or older with
- Compensated shock as defined by Shock Index (SI)>0.9 and
- Intravenous pain medication indicated prior to arrival at the participating trauma center
Anyone may opt-out of the study by contacting the study team. 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.
If you would like to read more about this study, please contact the local study team at trauma-research@cooperhealth.edu, visit the national website at https://www.litesnetwork.org/pain/, and watch the study video at https://youtu.be/OAW1Xcbb0r4.
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 Cooper University Health Care
Cooper University Health Care, with its MD Anderson Cancer Center at Cooper and affiliation with Cooper Medical School of Rowan University, is a leading academic health system. Cooper has 10,000 team members including 1,600 nurses, and more than 900 employed physicians and 450 advanced practice providers. Cooper University Hospital has been recognized as a top-performing regional hospital by U.S. News & World Report’s 2022-2023 Best Hospitals annual survey and has an “A” Hospital Safety Grade from The Leapfrog Group, a national nonprofit upholding the standard of patient safety in hospitals and ambulatory surgery centers.
Cooper has revenues of more than $2 billion and has an “A-“rating from S&P Global Ratings and “A3” rating from Moody’s Investors Service. Cooper University Hospital is the only Level 1 Trauma Center in South Jersey and the busiest in the region. Nearly two million patients are served annually at Cooper’s 663-bed flagship hospital, outpatient surgery center, three urgent care centers, and more than 100 ambulatory offices throughout the community. Cooper has been named as one of America’s Best Employers by Forbes for two consecutive years.
The Cooper Health Sciences campus in Camden, New Jersey, is home to Cooper University Hospital, MD Anderson Cancer Center at Cooper, Children’s Regional Hospital at Cooper, and Cooper Medical School of Rowan University. Visit CooperHealth.org to learn more.
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