Prehospital Analgesia INtervention Trial (PAIN)

Recruiting now · Phase 3

Conditions studied: Traumatic Injury

In brief

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 facts

Study ID

NCT05437575

Run by

Jason Sperry

People needed

994

Starts

2023-11-27

Expected to finish

2029-07-01

Last updated by the study team

2026-03-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California, San Diego — San Diego, California, United States (enrolling)
• Zuckerberg San Francisco General Hospital — San Francisco, California, United States (enrolling)
• Cooper University Health Care — Camden, New Jersey, United States (enrolling)
• Atrium Health and Carolinas Medical Center — Charlotte, North Carolina, United States (enrolling)
• University of Cincinnati — Cincinnati, Ohio, United States (enrolling)
• Allegheny Health Network (AHN) Allegheny General Hospital — Pittsburgh, Pennsylvania, United States (enrolling)
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States (enrolling)
• Guthrie Robert Packer Hospital — Sayre, Pennsylvania, United States (enrolling)
• University of Utah — Salt Lake City, Utah, United States (enrolling)
• The University of Vermont Larner College of Medicine — Burlington, Vermont, United States (enrolling)
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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