What is PAIN?
Prehospital Analgesia INtervention Trial, or simply PAIN, is a research study that is being done to compare giving fentanyl or ketamine through an IV for pain management in patients with traumatic injuries who need treatment for pain before they arrive at the hospital.
The management of pain following a severe injury is an essential part of caring for an injured patient. Opioids, like fentanyl, are commonly used to treat pain. This study will compare fentanyl to ketamine, which is not an opioid, to see if people have fewer or less severe side effects with one medication over the other. Although fentanyl and ketamine are both currently used to treat pain, they are not currently FDA approved for use in patients with traumatic injuries before they arrive at the hospital. We will look at both groups to better understand pain management for trauma injuries in the future.
Click here to complete a survey about PAIN.
Who will be included?
PAIN will include adults who are:
• Males over the age of 18 years and females who are over the age of 50
• Severely injured patients that require pain medication through an IV
• Patients being transported to a hospital participating in PAIN
Why Pain Management in the Prehospital Setting?
Giving pain medication to patients with severe injuries as soon as possible after they are hurt reduces suffering, can lessen health problems caused by the injury, and may lessen long term problems such as chronic pain and posttraumatic stress disorder (PTSD). Some patients may be contacted 6 months after their injury to see if they have complications like opioid use or dependency, anxiety, or post-traumatic stress disorder (PTSD).
Trauma patients with severe injuries need to receive pain medications quickly. These medications need to be given as close to the time of injury as possible to minimize suffering. In addition, these medications are often needed to help allow EMS providers to give lifesaving treatments.
What are the risks? Are there any benefits?
Patients in the study will receive either fentanyl or ketamine for pain management. We are unsure if there are benefits to receiving one medication over the other. Patients in this study and the EMS providers giving the medicine before the patients arrive at the hospital will not know if it is fentanyl or ketamine. If the patient’s doctor needs to know which medicine was given to treat the patient, they can get that information.
Fentanyl is an opioid medication commonly used for the treatment of pain for patients before they come to the hospital. Benefits of fentanyl over other common opioid medications include treating pain faster and having fewer side effects, such as nausea and vomiting.
The potential benefits of ketamine, which is not an opioid, for patients with severe injuries include possibly avoiding side effects of opioids such as very low blood pressure, low oxygen level, and the need to insert a breathing tube to help the patient breathe. Ketamine has been shown to be effective in treating pain, but in some cases may cause hallucinations, agitation, anxiety and a feeling of disconnectedness.
How are people enrolled in the study?
People who have severe injuries, need treatment for pain, and who are being transported to a hospital participating in the PAIN study may be included.
Normally, researchers must ask a person for their consent before they can be in a study. Because severe traumatic injuries must be treated right away, there may not be time to get consent. Giving consent for medical research usually means reading information, talking with doctors and nurses, and having time to think about whether to join. A person with traumatic injury is often not able to do these things. Sometimes researchers can talk to the patient’s family to ask for consent. However, in the emergency of traumatic injury, the family is often not around or can’t be found before the injured person must be treated. This study could not be done without special permission to include people before getting consent. This permission is called Exception From Informed Consent, or EFIC. Once the enrolled person is better and can consent or their family arrives at the hospital, the researchers will ask for consent to continue with the study. For more information regarding EFIC, please visit [https://www.litesnetwork.org/projects/emergency-research].
How do I opt out of the study?
You can opt-out of the study by contacting us using any of the methods below and letting us know that you do not want to participate. Please make sure to give us your name and contact information so that we can get in touch with you. We can provide you with a hypoallergenic silicone bracelet to wear that indicates that you should not be enrolled into the study. Please note that opting out of the study only means that you will not be part of the study. Opting out will not prevent you from getting pain medication as part of your normal care.
“This research is supported by DoD contract W81XWH-16-D-0024 W81XWH19F0539”
For questions or to learn more about this study, please call us at