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Prehospital Analgesia INtervention Trial (PAIN)

Prehospital Analgesia INtervention Trial (PAIN)

Recruiting
18 years and older
All
Phase 3

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Overview

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

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 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

Study details
    Traumatic Injury

NCT05437575

Jason Sperry

27 July 2025

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