Status:
RECRUITING
Prehospital Analgesia INtervention Trial (PAIN)
Lead Sponsor:
Jason Sperry
Collaborating Sponsors:
United States Department of Defense
Conditions:
Traumatic Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 patie...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2029
Estimated Enrollment :
994 Patients enrolled
Trial Details
Trial ID
NCT05437575
Start Date
November 27 2023
End Date
July 1 2029
Last Update
December 17 2025
Active Locations (10)
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1
University of California, San Diego
San Diego, California, United States, 92103
2
Zuckerberg San Francisco General Hospital
San Francisco, California, United States, 94110
3
Cooper University Health Care
Camden, New Jersey, United States, 08103
4
Atrium Health and Carolinas Medical Center
Charlotte, North Carolina, United States, 28203