Prehospital Analgesia INtervention Trial (PAIN)
Jason Sperry
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 or HR ≥115) and an indication for pain management, comparing patient centered outcomes following prehospital administration of ketamine hydrochloride versus fentanyl citrate.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 sc…
Interventions
- DrugKetamine Hydrochloride
ketamine hydrochloride 2.5mg/ml packaged in pre-filled syringe
- DrugFentanyl Citrate
fentanyl citrate 10mcg/ml packaged in pre-filled syringe
Locations (11)
- University of California, San DiegoSan Diego, California
- Zuckerberg San Francisco General HospitalSan Francisco, California
- Cooper University Health CareCamden, New Jersey
- Atrium Health and Carolinas Medical CenterCharlotte, North Carolina
- University of CincinnatiCincinnati, Ohio
- Allegheny Health Network (AHN) Allegheny General HospitalPittsburgh, Pennsylvania