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RECRUITING
NCT05437575
PHASE3

Prehospital Analgesia INtervention Trial (PAIN)

Sponsor: Jason Sperry

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

994

Start Date

2023-11-27

Completion Date

2029-07

Last Updated

2026-03-09

Healthy Volunteers

No

Interventions

DRUG

Ketamine Hydrochloride

ketamine hydrochloride 2.5mg/ml packaged in pre-filled syringe

DRUG

Fentanyl Citrate

fentanyl citrate 10mcg/ml packaged in pre-filled syringe

Locations (11)

University of California, San Diego

San Diego, California, United States

Zuckerberg San Francisco General Hospital

San Francisco, California, United States

Cooper University Health Care

Camden, New Jersey, United States

Atrium Health and Carolinas Medical Center

Charlotte, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

Allegheny Health Network (AHN) Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Guthrie Robert Packer Hospital

Sayre, Pennsylvania, United States

University of Utah

Salt Lake City, Utah, United States

The University of Vermont Larner College of Medicine

Burlington, Vermont, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States