RecruitingPhase 3ketamine
Prehospital Analgesia INtervention Trial (PAIN)
Sponsored by Jason Sperry
NCT ID
NCT05437575
Target Enrollment
994 participants
Start Date
2023-11-27
Est. Completion
2029-07
About This Study
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.
Conditions Studied
Interventions
- •Ketamine Hydrochloride
- •Fentanyl Citrate
Eligibility
Age:18 Years - N/A
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria: * 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 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 Locations (11)
University of California, San Diego
San Diego, California, United States
Zuckerberg San Francisco General Hospital
San Francisco, California, United States
Cooper University Health Care
Camden, New Jersey, United States
Atrium Health and Carolinas Medical Center
Charlotte, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Allegheny Health Network (AHN) Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Guthrie Robert Packer Hospital
Sayre, Pennsylvania, United States
University of Utah
Salt Lake City, Utah, United States
The University of Vermont Larner College of Medicine
Burlington, Vermont, United States
+1 more locations