PAIN Trial: Ketamine vs. Fentanyl for Trauma Pain

This study, called the Prehospital Analgesia INtervention (PAIN) trial, is looking at the best way to manage pain for people with traumatic injuries before they get to the hospital. Researchers want to compare two pain medications: ketamine hydrochloride and fentanyl citrate. You might be able to join if you're at least 18 years old, are being transported to a participating trauma center after an injury, have signs of compensated shock (like a fast heart rate), and need pain medication. The main goal is to see if one medication leads to better patient outcomes, specifically looking at survival within 24 hours of arriving at the trauma bay. The study plans to enroll about 994 patients, but its current status is unclear.

Study design
This is a randomized, double-blind study, meaning participants will be randomly assigned to receive either ketamine hydrochloride or fentanyl citrate, and neither you nor your doctors will know which one you're getting. It plans to enroll about 994 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track your survival for 24 hours after you arrive at the trauma bay.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05437575

Prehospital Analgesia INtervention Trial (PAIN)

Recruiting
PHASE3Ages 18+InterventionalTreatment
Jason Sperry
~994 participants
Updated 2026-03-09 on ClinicalTrials.gov
What's tested:Ketamine HydrochlorideFentanyl Citrate

At a glance

Recruiting sites
10 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
24-hour mortality
Measured over trauma bay arrival through 24 hours
Traumatic Injury
11 sites across 8 states
Pennsylvania3
California2
New Jersey1
North Carolina1
Ohio1
Utah1
Vermont1
Wisconsin1
  • Jason Sperry, MD · PRINCIPAL_INVESTIGATOR · University of Pittsburgh

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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
  • 24-hour mortalitytrauma bay arrival through 24 hours

    All cause mortality within 24 hours from time of trauma bay arrival