Prehospital Analgesia INtervention Trial (PAIN)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorJason Sperry

About this trial

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 criteria

Qualifiers

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

Disqualifiers

No IV access

Age <18 years

Females <50 years of age

SBP>180 mmHg at time of enrollment

Trial design

Treatments tested in this trial

  • Ketamine Hydrochloride
  • Fentanyl Citrate

Treatment groups

994 Participants
are divided into 2 treatment groups

Locations

11
California
University of California, San Diego92103, San Diego United States
Zuckerberg San Francisco General Hospital94110, San Francisco United States
New Jersey
Cooper University Health Care08103, Camden United States
North Carolina
Atrium Health and Carolinas Medical Center28203, Charlotte United States

Sponsors and collaborators

Jason Sperry

Lead sponsor

University of Pittsburgh

Sponsor institution

United States Department of Defense

Collaborator