Prehospital Analgesia INtervention Trial (PAIN)

Last updated: May 27, 2025
Sponsor: Jason Sperry
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Ketamine Hydrochloride

Fentanyl Citrate

Clinical Study ID

NCT05437575
STUDY22010164
W81XWH- 6-D-0024
  • Ages > 18
  • All Genders

Study 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) and an indication for pain management, comparing patient centered outcomes following prehospital administration of ketamine hydrochloride versus fentanyl citrate.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Transport after injury to a participating PAIN Trauma center

  • Patient with compensated shock as defined by Shock Index (SI) ≥0.9

  • Intravenous pain medication indicated (CPOT≥2, NRS≥5) prior to arrival at the traumacenter

Exclusion

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

Study Design

Total Participants: 994
Treatment Group(s): 2
Primary Treatment: Ketamine Hydrochloride
Phase: 3
Study Start date:
November 27, 2023
Estimated Completion Date:
July 31, 2029

Connect with a study center

  • University of California, San Diego

    San Diego, California 92103
    United States

    Active - Recruiting

  • Cooper University Health Care

    Camden, New Jersey 08103
    United States

    Active - Recruiting

  • Atrium Health and Carolinas Medical Center

    Charlotte, North Carolina 28203
    United States

    Active - Recruiting

  • University of Cincinnati

    Cincinnati, Ohio 45267
    United States

    Active - Recruiting

  • Allegheny Health Network (AHN) Allegheny General Hospital

    Pittsburgh, Pennsylvania 15212
    United States

    Active - Recruiting

  • University of Pittsburgh

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • Guthrie Robert Packer Hospital

    Sayre, Pennsylvania 18840
    United States

    Active - Recruiting

  • University of Utah

    Salt Lake City, Utah 84132
    United States

    Active - Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53266
    United States

    Active - Recruiting

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