Prehospital Analgesia INtervention Trial (PAIN)

• Status: Not yet recruiting
• Trial end date: 2026-09-01
• Target enrollment: 0
• Participant gender: All

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 1,544 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) and an indication for pain management, comparing patient centered outcomes following prehospital administration of ketamine hydrochloride versus fentanyl citrate.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jason Sperry
• Collaborator: United States Department of Defense
• Treatments: Fentanyl; Ketamine

Criteria

Inclusion Criteria:

• Trauma activation (Level I or Level II) and transport from the scene of injury to a participating LITES Trauma center

• Patient with compensated shock as defined by Shock Index (SI) >0.9

• Intravenous pain medication indicated (CPOT>2, NRS>5)

Exclusion Criteria:

• No IV access

• Age <18 years

• Females <50 years of age

• SBP>180 mmHg

• Received pain medication prior to enrollment

• Advanced airway management prior to first dose administration

• Known allergy to fentanyl citrate or ketamine hydrochloride

• Prisoner

• Objection to study voiced by subject or family member at scene

• Pain treatment contraindicated by local protocol

• Wearing a "NO PAIN" bracelet