Recruiting

Phase 3

PAINPrehospital Analgesia INtervention Trial (PAIN)

Sponsor:

Jason Sperry

Code:

NCT05437575

Conditions

Traumatic Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ketamine Hydrochloride

Fentanyl Citrate

Study Details

Brief 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

Study ID

NCT05437575

Start date

Nov 27, 2023

Status verified date

Mar, 2026

Completion date

Jul, 2029

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

994 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ketamine Hydrochloride

2 blinded doses 2.5mg/ml ketamine hydrochloride in separately sealed pre-filled syringes Subjects will be administered the first dose over approximately 2 minutes via slow IV push. Pain assessment following administration will be obtained and recorded every 15 minutes. Redosing may occur after approximately 15 minutes if the subject has a qualifying pain score, there are no contraindications to pain medication per local protocol, and no exclusion criteria have been met.

active comparator: Fentanyl Citrate

2 blinded doses 10mcg/ml in separately sealed pre-filled syringes Subjects will be administered the first dose over approximately 2 minutes via slow IV push. Pain assessment following administration will be obtained and recorded every 15 minutes. Redosing may occur after approximately 15 minutes if the subject has a qualifying pain score, there are no contraindications to pain medication per local protocol, and no exclusion criteria have been met.

Interventions

Ketamine Hydrochloride

ketamine hydrochloride 2.5mg/ml packaged in pre-filled syringe

Fentanyl Citrate

fentanyl citrate 10mcg/ml packaged in pre-filled syringe

Primary outcome measure

24-hour mortality [ Time Frame: trauma bay arrival through 24 hours ]

Central Contacts and Locations

Central contacts

Jason Sperry, MD

412-802-8270 sperryjl@upmc.edu

Locations

University of California, San Diego

Recruiting

San Diego, California, United States, 92103

Contacts

Laura Haines, MD

619-543-7200 lhaines@health.ucsd.edu

Zuckerberg San Francisco General Hospital

Recruiting

San Francisco, California, United States, 94110

Contacts

Lucy Kornblith, MD

415-609-6924 Lucy.Kornblith@ucsf.edu

Cooper University Health Care

Recruiting

Camden, New Jersey, United States, 08103

Contacts

Tanya Egodage

856-342-3341 egodage-tanya@cooperhealth.edu

Atrium Health and Carolinas Medical Center

Recruiting

Charlotte, North Carolina, United States, 28203

Contacts

Addison May, MD

704 446-2504 addison.may@atriumhealth.org

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45267

Contacts

Jason McMullan, MD

513-675-3072 Jason.McMullan@uc.edu

Allegheny Health Network (AHN) Allegheny General Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contacts

Philip Nawrocki, MD

4124876590 philip.nawrocki@ahn.org

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Jason Sperry, MD

412-647-3065 sperryjl@upmc.edu

Principal Investigator:

Jason Sperry, MD

Guthrie Robert Packer Hospital

Recruiting

Sayre, Pennsylvania, United States, 18840

Contacts

Jon Rittenberger, MD

570-887-4318 Jon.Rittenberger@guthrie.org

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84132

Contacts

Scott Youngquist, MD

scott.youngquist@hsc.utah.edu

The University of Vermont Larner College of Medicine

Recruiting

Burlington, Vermont, United States, 05405

Contacts

Daniel Wolfson, MD, FACEP, FAEMS

802-847-2434 daniel.wolfson@uvmhealth.org

More Information

Sponsor

Jason Sperry

Last update posted

Mar 9, 2026

Last verified

Mar, 2026

Keywords

Trauma
ketamine hydrochloride
fentanyl citrate
shock
pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Jason Sperry on 2026-03-09.