Prehospital Analgesia INtervention Trial (PAIN)
Purpose
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.
Condition
- Traumatic Injury
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
University of California, San Diego
San Diego, California 92103
San Diego, California 92103
Zuckerberg San Francisco General Hospital
San Francisco, California 94110
San Francisco, California 94110
Cooper University Health Care
Camden, New Jersey 08103
Camden, New Jersey 08103
Atrium Health and Carolinas Medical Center
Charlotte, North Carolina 28203
Charlotte, North Carolina 28203
University of Cincinnati
Cincinnati, Ohio 45267
Cincinnati, Ohio 45267
Allegheny Health Network (AHN) Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
Pittsburgh, Pennsylvania 15212
University of Pittsburgh
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
Guthrie Robert Packer Hospital
Sayre, Pennsylvania 18840
Sayre, Pennsylvania 18840
University of Utah
Salt Lake City, Utah 84132
Salt Lake City, Utah 84132
The University of Vermont Larner College of Medicine
Burlington, Vermont 05405
Burlington, Vermont 05405
More Details
- NCT ID
- NCT05437575
- Status
- Recruiting
- Sponsor
- Jason Sperry