Prehospital Analgesia INtervention Trial (PAIN)

Launched by JASON SPERRY · Jun 24, 2022

Keywords

ClinConnect Summary

The Prehospital Analgesia INtervention Trial (PAIN) is a research study that aims to find out the best way to manage pain in patients who have experienced traumatic injuries and are in a state called "compensated shock," meaning their body is still able to maintain blood flow despite the injury. This trial will compare two pain relief medications: ketamine and fentanyl. The goal is to see which one works better for patients before they reach the hospital. The study will take place over four years and plans to enroll about 994 participants at various locations.

To be eligible for this trial, patients must be at least 18 years old, have signs of compensated shock (specifically, a Shock Index score of 0.9 or higher), and require intravenous pain medication for their injury. Participants will receive one of the two medications while being transported to the hospital. It's important to know that certain individuals, like those with severe high blood pressure or known allergies to the study drugs, will not be able to participate. By joining this trial, participants will help researchers better understand how to effectively manage pain for trauma patients in emergency situations.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Transport after injury to a participating PAIN Trauma center
• • Patient with compensated shock as defined by Shock Index (SI) ≥0.9
• • Intravenous pain medication indicated (CPOT≥2, NRS≥5) prior to arrival at the trauma center
• Exclusion Criteria:
• • No IV access
• • Age \<18 years
• • Females \<50 years of age
• • SBP\>180 mmHg at time of enrollment
• • Advanced airway management prior to first dose administration
• • Known allergy to fentanyl citrate or ketamine hydrochloride
• • Known prisoner
• • Objection to study voiced by subject or family member at scene
• • Pain treatment contraindicated by local protocol
• • Wearing a "NO PAIN STUDY" bracelet