Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT05437575

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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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

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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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Prehospital Analgesia INtervention Trial (PAIN) | DecenTrialz