Actively Recruiting
Prehospital Analgesia INtervention Trial (PAIN)
Led by Jason Sperry · Updated on 2026-03-09
994
Participants Needed
11
Research Sites
291 weeks
Total Duration
On this page
Sponsors
J
Jason Sperry
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
The Prehospital Analgesia INtervention trial (PAIN) is a proposed 4 year (3-year enrollment) multicenter, prehospital, randomized, double-blind, clinical trial that will enroll approximately 994 patients at select LITES Network sites. The objective is to perform a prospective, interventional, randomized trial among prehospital trauma patients with compensated shock (SI≥0.9 or HR ≥115) and an indication for pain management, comparing patient centered outcomes following prehospital administration of ketamine hydrochloride versus fentanyl citrate.
CONDITIONS
Official Title
Prehospital Analgesia INtervention Trial (PAIN)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Transport after injury to a participating PAIN Trauma center
- Patient with compensated shock as defined by Shock Index (SI) 60.9 or Heart Rate (HR) 60115
- Intravenous pain medication indicated (CPOT652, NRS655) prior to arrival at the trauma center
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 11 locations
1
University of California, San Diego
San Diego, California, United States, 92103
Actively Recruiting
2
Zuckerberg San Francisco General Hospital
San Francisco, California, United States, 94110
Actively Recruiting
3
Cooper University Health Care
Camden, New Jersey, United States, 08103
Actively Recruiting
4
Atrium Health and Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Actively Recruiting
5
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Actively Recruiting
6
Allegheny Health Network (AHN) Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
7
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
8
Guthrie Robert Packer Hospital
Sayre, Pennsylvania, United States, 18840
Actively Recruiting
9
University of Utah
Salt Lake City, Utah, United States, 84132
Actively Recruiting
10
The University of Vermont Larner College of Medicine
Burlington, Vermont, United States, 05405
Actively Recruiting
11
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53266
Suspended
Research Team
J
Jason Sperry, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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