NCT05437575

Prehospital Analgesia INtervention Trial (PAIN)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 994 (estimated)
• Sponsor: Jason Sperry · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Traumatic Injury

Interventions

Type	Name	Description
DRUG	Ketamine Hydrochloride	ketamine hydrochloride 2.5mg/ml packaged in pre-filled syringe
DRUG	Fentanyl Citrate	fentanyl citrate 10mcg/ml packaged in pre-filled syringe

Timeline

• Start date: 2023-11-27
• Primary completion: 2028-07-01
• Completion: 2029-07-01
• First posted: 2022-06-29
• Last updated: 2026-03-09

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study