RECRUITING

Prehospital Analgesia INtervention Trial (PAIN)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 or HR ≥115) and an indication for pain management, comparing patient centered outcomes following prehospital administration of ketamine hydrochloride versus fentanyl citrate.

Official Title

Prehospital Analgesia INtervention Trial (PAIN)

Quick Facts

Study Start:2023-11-27
Study Completion:2029-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05437575

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Transport after injury to a participating PAIN Trauma center
  2. * 2\. Patient with compensated shock as defined by Shock Index (SI) ≥0.9 or Heart Rate (HR) ≥115.
  3. * Intravenous pain medication indicated (CPOT≥2, NRS≥5) prior to arrival at the trauma center
  1. * No IV access
  2. * Age \<18 years
  3. * Females \<50 years of age
  4. * SBP\>180 mmHg at time of enrollment
  5. * Advanced airway management prior to first dose administration
  6. * Known allergy to fentanyl citrate or ketamine hydrochloride
  7. * Known prisoner
  8. * Objection to study voiced by subject or family member at scene
  9. * Pain treatment contraindicated by local protocol
  10. * Wearing a "NO PAIN STUDY" bracelet

Contacts and Locations

Study Contact

Jason Sperry, MD
CONTACT
412-802-8270
sperryjl@upmc.edu

Principal Investigator

Jason Sperry, MD
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

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
Medical College of Wisconsin
Milwaukee, Wisconsin, 53266
United States

Collaborators and Investigators

Sponsor: Jason Sperry

  • Jason Sperry, MD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-27
Study Completion Date2029-07

Study Record Updates

Study Start Date2023-11-27
Study Completion Date2029-07

Terms related to this study

Keywords Provided by Researchers

  • Trauma
  • ketamine hydrochloride
  • fentanyl citrate
  • shock
  • pain

Additional Relevant MeSH Terms

  • Traumatic Injury