Comparing ketamine and fentanyl for pain management in trauma patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Jason Sperry, MD — University of Pittsburgh
• Study coordinator: Jason Sperry, MD
• Email: sperryjl@upmc.edu
• Phone: 412-802-8270

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.