The 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 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 numerous 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 Dr. Tanya Egodage, 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 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 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 ClinicalTrials.gov and refer to NCT05437575. Opting out will not prevent trauma patients from receiving pain medication, only from enrollment in the study.