Comparing ketamine and fentanyl for pain management in trauma patients
Prehospital Analgesia INtervention Trial (PAIN)
This study is testing whether ketamine or fentanyl works better for managing pain in trauma patients before they reach the hospital.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 994 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 11 sites (San Diego, California and 10 other locations) |
| Trial ID | NCT05437575 on ClinicalTrials.gov |
What this trial studies
The Prehospital Analgesia INtervention trial (PAIN) is a multicenter, randomized, double-blind clinical trial designed to evaluate the effectiveness of ketamine hydrochloride versus fentanyl citrate for pain management in prehospital trauma patients experiencing compensated shock. The study will enroll approximately 994 patients over three years at select LITES Network sites. Participants will receive either ketamine or fentanyl before being transported to a trauma center, with outcomes assessed based on patient-centered measures. This trial aims to improve pain management protocols in emergency settings.
Who should consider this trial
Good fit: Ideal candidates include trauma patients with compensated shock who require intravenous pain medication.
Not a fit: Patients without IV access, those under 18 years old, or individuals with contraindications to the medications will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance pain management strategies for trauma patients, leading to better patient outcomes.
How similar studies have performed: Other studies have explored similar analgesic approaches, but this specific comparison of ketamine and fentanyl in prehospital settings is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Transport after injury to a participating PAIN Trauma center * 2\. Patient with compensated shock as defined by Shock Index (SI) ≥0.9 or Heart Rate (HR) ≥115. * 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
Where this trial is running
San Diego, California and 10 other locations
- University of California, San Diego — San Diego, California, United States (Recruiting)
- Zuckerberg San Francisco General Hospital — San Francisco, California, United States (Recruiting)
- Cooper University Health Care — Camden, New Jersey, United States (Recruiting)
- Atrium Health and Carolinas Medical Center — Charlotte, North Carolina, United States (Recruiting)
- University of Cincinnati — Cincinnati, Ohio, United States (Recruiting)
- Allegheny Health Network (AHN) Allegheny General Hospital — Pittsburgh, Pennsylvania, United States (Recruiting)
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
- Guthrie Robert Packer Hospital — Sayre, Pennsylvania, United States (Recruiting)
- University of Utah — Salt Lake City, Utah, United States (Recruiting)
- The University of Vermont Larner College of Medicine — Burlington, Vermont, United States (Recruiting)
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Suspended)
Study contacts
- Principal investigator: Jason Sperry, MD — University of Pittsburgh
- Study coordinator: Jason Sperry, MD
- Email: sperryjl@upmc.edu
- Phone: 412-802-8270
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.