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Recruiting NCT05437575

Prehospital Analgesia INtervention Trial (PAIN)

Phase III Interventional Traumatic Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ketamine Hydrochloride, Fentanyl Citrate.
Who it may be relevant to
Registry conditions: Traumatic Injury. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

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]
Secondary outcome measures (12)
  • Hypoxia [Time frame: from initial administration of PAIN prehospital analgesia through hospital arrival]
  • Hypotension [Time frame: from initial administration of PAIN study prehospital analgesia through hospital arrival]
  • Need for airway management [Time frame: from initial administration of PAIN study prehospital analgesia through hospital arrival]
  • Prehospital pain assessment following analgesia [Time frame: from initial administration of PAIN study prehospital analgesia through hospital arrival]
  • Trauma bay arrival pain score [Time frame: score assessed at time of arrival to trauma bay]
  • Number of analgesic doses necessary to reduce pain level to <5 NRS or CPOT less than 2 [Time frame: from initial administration of PAIN study prehospital analgesia through hospital arrival]
  • 24 hour opioid use [Time frame: from initial administration of PAIN study prehospital analgesia through 24 hours]
  • Incidence of prehospital adverse events [Time frame: from initial administration of PAIN study prehospital analgesia through hospital arrival]
  • Survival to hospital discharge [Time frame: administration of PAIN study prehospital analgesia through hospital discharge or death up to 30 days]
  • Ventilator free days [Time frame: from administration of PAIN study prehospital analgesia through hospital discharge or death up to 30 days]
  • Intensive Care Unit free days [Time frame: from administration of PAIN study prehospital analgesia through hospital discharge or death up to 30 days]
  • Long term opioid use [Time frame: 3 months (+/- 1 month) and 6 months (+/- 1 month) following trauma admission]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 11 centers
  • University of California, San Diego — San Diego
  • Zuckerberg San Francisco General Hospital — San Francisco
  • Cooper University Health Care — Camden
  • Atrium Health and Carolinas Medical Center — Charlotte
  • University of Cincinnati — Cincinnati
  • Allegheny Health Network (AHN) Allegheny General Hospital — Pittsburgh
  • University of Pittsburgh — Pittsburgh
  • Guthrie Robert Packer Hospital — Sayre
  • … and 3 more centers

Identifiers

NCT: NCT05437575 · STUDY22010164 · HT9425-25-F-0041

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗