Prehospital Analgesia INtervention Trial (PAIN)

Prehospital Analgesia INtervention Trial (PAIN)

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.

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