Actively Recruiting
Prehospital Analgesia INtervention Trial (PAIN) Comparing Ketamine Hydrochloride and Fentanyl Citrate in Traumatic Injury Patients
Led by Jason Sperry · Updated on 2026-03-09
994
Participants Needed
11
Research Sites
52 weeks
Total Duration
On this page
Sponsors
J
Jason Sperry
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating pain management in prehospital trauma patients who have compensated shock, defined by specific heart rate or shock index criteria, and require pain treatment. This Phase 3, randomized, double-blind clinical trial aims to compare outcomes after administering ketamine hydrochloride versus fentanyl citrate before arrival at trauma centers. The trial will enroll about 994 patients over three years at select sites in the LITES Network. Participants receive either ketamine hydrochloride (2.5 mg/ml) or fentanyl citrate (10 mcg/ml) via slow intravenous push over about two minutes. Pain is assessed every 15 minutes after dosing, with possible redosing if pain scores remain high and no contraindications exist. Both treatments are provided in blinded, pre-filled syringes. The study focuses on prehospital care and monitoring through hospital arrival and beyond. During the study, researchers will monitor pain levels, adverse events, need for airway management, mortality within 24 hours, opioid use, and long-term outcomes including pain and opioid use up to six months after trauma. Assessments include pain scales at arrival and during hospital stay, ICU and ventilator-free days, and screening for anxiety and PTSD. Safety and survival to discharge are also tracked, with participation lasting through hospital discharge and follow-up visits up to six months.
CONDITIONS
Brief Title
Prehospital Analgesia INtervention Trial (PAIN)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Transport after injury to a participating PAIN Trauma center
- Patient with compensated shock defined by Shock Index 0.9 or Heart Rate 115
- Intravenous pain medication indicated (CPOT 2, NRS 5) before trauma center arrival
- Age 18 years or older
You will not qualify if you...
- No intravenous (IV) access
- Age under 18 years
- Females under 50 years old
- Systolic blood pressure over 180 mmHg at enrollment
- Advanced airway management before first dose
- Known allergy to fentanyl citrate or ketamine hydrochloride
- Known prisoner status
- Objection to study by subject or family at scene
- Pain treatment contraindicated by local protocol
- Wearing a "NO PAIN STUDY" bracelet
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - From initial administration until hospital arrival
Participants receive either ketamine hydrochloride or fentanyl citrate through intravenous administration to manage pain after traumatic injury. Pain assessments are performed every 15 minutes during treatment to evaluate effectiveness and determine the need for additional doses.
Continuous monitoring during prehospital care with pain assessments every 15 minutes
Duration - Up to 6 months after hospital arrival
Participants are monitored for outcomes including pain levels, opioid use, adverse events, and survival up to 6 months following hospital admission.
Visits and assessments at hospital arrival, discharge, 3 months, and 6 months post-admission
Trial Site Locations
Total: 11 locations
1
University of California, San Diego
San Diego, California, United States, 92103
Actively Recruiting
2
Zuckerberg San Francisco General Hospital
San Francisco, California, United States, 94110
Actively Recruiting
3
Cooper University Health Care
Camden, New Jersey, United States, 08103
Actively Recruiting
4
Atrium Health and Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Actively Recruiting
5
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Actively Recruiting
6
Allegheny Health Network (AHN) Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
7
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
8
Guthrie Robert Packer Hospital
Sayre, Pennsylvania, United States, 18840
Actively Recruiting
9
University of Utah
Salt Lake City, Utah, United States, 84132
Actively Recruiting
10
The University of Vermont Larner College of Medicine
Burlington, Vermont, United States, 05405
Actively Recruiting
11
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53266
Suspended
Research Team
J
Jason Sperry, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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