Prehospital Analgesia INtervention Trial (PAIN)

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≥0.9) and an indication for pain management, comparing patient centered outcomes following prehospital administration of ketamine hydrochloride versus fentanyl citrate.

Conditions

Traumatic Injury

Study Overview

Study Details

Study overview

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) and an indication for pain management, comparing patient centered outcomes following prehospital administration of ketamine hydrochloride versus fentanyl citrate.

Prehospital Analgesia INtervention Trial (PAIN)

Prehospital Analgesia INtervention Trial (PAIN)

Condition
Traumatic Injury
Intervention / Treatment

-

Contacts and Locations

Camden

Cooper University Health Care, Camden, New Jersey, United States, 08103

Pittsburgh

Allegheny Health Network (AHN) Allegheny General Hospital, Pittsburgh, Pennsylvania, United States, 15212

Pittsburgh

University of Pittsburgh, Pittsburgh, Pennsylvania, United States, 15213

Milwaukee

Medical College of Wisconsin, Milwaukee, Wisconsin, United States, 53266

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Jason Sperry,

Jason Sperry, MD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

2026-09