Prehospital Analgesia INtervention Trial (PAIN)
Jason Sperry
994 participants
Nov 27, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- Transport after injury to a participating PAIN Trauma center
- \. 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 Criteria10
- 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
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Interventions
ketamine hydrochloride 2.5mg/ml packaged in pre-filled syringe
fentanyl citrate 10mcg/ml packaged in pre-filled syringe
Locations(11)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05437575