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NCT05437575PHASE3Recruiting

Prehospital Analgesia INtervention Trial (PAIN)

Jason Sperry

Start Date

11/27/2023

Completion Date

7/1/2029

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Ketamine Hydrochloride

DRUG

Fentanyl Citrate

Interested in This Trial?

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Conditions

Traumatic Injury

Locations

University of California, San Diego

San Diego, California 92103

United States

Zuckerberg San Francisco General Hospital

San Francisco, California 94110

United States

Cooper University Health Care

Camden, New Jersey 08103

United States

Atrium Health and Carolinas Medical Center

Charlotte, North Carolina 28203

United States

University of Cincinnati

Cincinnati, Ohio 45267

United States

Allegheny Health Network (AHN) Allegheny General Hospital

Pittsburgh, Pennsylvania 15212

United States

University of Pittsburgh

Pittsburgh, Pennsylvania 15213

United States

Guthrie Robert Packer Hospital

Sayre, Pennsylvania 18840

United States

University of Utah

Salt Lake City, Utah 84132

United States

The University of Vermont Larner College of Medicine

Burlington, Vermont 05405

United States

Medical College of Wisconsin

Milwaukee, Wisconsin 53266

United States