Prehospital Analgesia INtervention Trial (PAIN)
PAIN
2 other identifiers
interventional
994
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2023
Longer than P75 for phase_3
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2022
CompletedFirst Posted
Study publicly available on registry
June 29, 2022
CompletedStudy Start
First participant enrolled
November 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2029
March 9, 2026
March 1, 2026
4.6 years
May 24, 2022
March 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
24-hour mortality
All cause mortality within 24 hours from time of trauma bay arrival
trauma bay arrival through 24 hours
Secondary Outcomes (16)
Hypoxia
from initial administration of PAIN prehospital analgesia through hospital arrival
Hypotension
from initial administration of PAIN study prehospital analgesia through hospital arrival
Need for airway management
from initial administration of PAIN study prehospital analgesia through hospital arrival
Prehospital pain assessment following analgesia
from initial administration of PAIN study prehospital analgesia through hospital arrival
Trauma bay arrival pain score
score assessed at time of arrival to trauma bay
- +11 more secondary outcomes
Study Arms (2)
Ketamine Hydrochloride
EXPERIMENTAL2 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.
Fentanyl Citrate
ACTIVE COMPARATOR2 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 2.5mg/ml packaged in pre-filled syringe
Eligibility Criteria
You may qualify if:
- Transport after injury to a participating PAIN Trauma center
- \. 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jason Sperrylead
- United States Department of Defensecollaborator
Study Sites (11)
University of California, San Diego
San Diego, California, 92103, United States
Zuckerberg San Francisco General Hospital
San Francisco, California, 94110, United States
Cooper University Health Care
Camden, New Jersey, 08103, United States
Atrium Health and Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Allegheny Health Network (AHN) Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Guthrie Robert Packer Hospital
Sayre, Pennsylvania, 18840, United States
University of Utah
Salt Lake City, Utah, 84132, United States
The University of Vermont Larner College of Medicine
Burlington, Vermont, 05405, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53266, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jason Sperry, MD
University of Pittsburgh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 24, 2022
First Posted
June 29, 2022
Study Start
November 27, 2023
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
July 1, 2029
Last Updated
March 9, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Data will become available after publication of the primary manuscript
- Access Criteria
- Requests for data will be submitted in writing and reviewed by the Principal Investigator.
De-identified data may be shared with the funding agency as well as other researchers upon request to the Principal Investigator