Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
completion around

Description

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.

Keywords

Traumatic Injury, Trauma, ketamine hydrochloride, fentanyl citrate, shock, pain, Wounds and Injuries, Fentanyl, Ketamine

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join 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

Locations

  • University of California, San Diego accepting new patients
    San Diego California 92103 United States
  • University of Utah accepting new patients
    Salt Lake City Utah 84132 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Jason Sperry
ID
NCT05437575
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 994 study participants
Last Updated