NCT05437575 · Jason Sperry
Prehospital Analgesia INtervention Trial (PAIN)
(PAIN)
What this study is about
The Prehospital Analgesia INtervention trial (PAIN) is a proposed 4 year (3-year enrollment) conducted at multiple hospitals, prehospital, randomly assigned, where neither patients nor doctors know which treatment is given, clinical trial that will enroll approximately 994 patients at select LITES Network sites.
View original scientific description
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.
Interventions
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
Primary outcome measures
24-hour mortality
Time frame: trauma bay arrival through 24 hours
All cause mortality within 24 hours from time of trauma bay arrival
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Transport after injury to a participating PAIN Trauma center
- Patient with compensated shock as defined by Shock Index (SI) ≥0.9
- 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
Where
- San Diego, California
- San Francisco, California
- Camden, New Jersey
- Charlotte, North Carolina
- Cincinnati, Ohio
- Pittsburgh, Pennsylvania
- Sayre, Pennsylvania
- Salt Lake City, Utah
- Burlington, Vermont
- Milwaukee, Wisconsin
Collaborators
United States Department of Defense
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 9, 2026 · Source of record for eligibility and locations