Prehospital Analgesia INtervention Trial (PAIN)

Phase 3RecruitingNCT05437575

Jason Sperry994 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

994

Conditions

Traumatic Injury

Interventions

Ketamine HydrochlorideDRUG

ketamine hydrochloride 2.5mg/ml packaged in pre-filled syringe

Fentanyl CitrateDRUG

fentanyl citrate 10mcg/ml packaged in pre-filled syringe

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (11)

University of California, San Diego

San Diego, California, United States

RECRUITING

Zuckerberg San Francisco General Hospital

San Francisco, California, United States

Outcomes

Primary Outcomes

24-hour mortality

All cause mortality within 24 hours from time of trauma bay arrival

Time frame: trauma bay arrival through 24 hours

Secondary Outcomes

Hypoxia

incidence of hypoxia in the prehospital environment

Time frame: from initial administration of PAIN prehospital analgesia through hospital arrival

Hypotension

incidence of hypotension in the prehospital environment

Time frame: from initial administration of PAIN study prehospital analgesia through hospital arrival

Need for airway management

need for airway management in the prehospital environment

Time frame: from initial administration of PAIN study prehospital analgesia through hospital arrival

Prehospital pain assessment following analgesia

prehospital pain assessment using Numeric Rating Scale (NRS)/Critical Care Pain Observational Tool (CPOT) scores. For Numeric Rating Scale, the patient rates their pain on a scale of 0 to 10 where 0 is no pain and 10 is the worst pain. The Critical Care Pain Observation Tool is used for patients who are intubated and cannot verbalize a pain score. Medical staff will observe the patient's behavior and score the patient's pain on a scale of 0 to 10, where 0 is no pain and 10 is the worst pain.

Time frame: from initial administration of PAIN study prehospital analgesia through hospital arrival

Trauma bay arrival pain score

pain assessment using Numeric Rating Scale (NRS)/Critical Care Pain Observation Tool (CPOT) score. For Numeric Rating Scale, patients rate their pain on a scale of 0 to 10 where 0 is no pain and 10 is the worst pain. The Critical Care Pain Observation Tool is used for patients who are intubated and cannot verbalize a pain score. A nurse will observe behavior and score the patient's pain on a scale of 0 to 10 where 0 is no pain and 10 is the worst pain.

Central Contacts

Jason Sperry, MD

CONTACT

412-802-8270 sperryjl@upmc.edu

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Cooper University Health Care

Camden, New Jersey, United States

RECRUITING

Atrium Health and Carolinas Medical Center

Charlotte, North Carolina, United States

RECRUITING

University of Cincinnati

Cincinnati, Ohio, United States

RECRUITING

Allegheny Health Network (AHN) Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

RECRUITING

Guthrie Robert Packer Hospital

Sayre, Pennsylvania, United States

RECRUITING

University of Utah

Salt Lake City, Utah, United States

RECRUITING

The University of Vermont Larner College of Medicine

Burlington, Vermont, United States

RECRUITING

...and 1 more locations

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

Number of analgesic doses necessary to reduce pain level to \<5 on Numeric Rating Scale or less than 2 on Critical Care Pain Observation Tool. For Numeric Rating Scale, the patient rates their pain on a scale of 0 to 10 where 0 is no pain and 10 is the worst pain. The Critical Care Pain Observation Tool is used for patients who are intubated and cannot verbalize a pain score. A nurse will observe behavior and score the patient's pain on a scale of 0 to 10 where 0 is no pain and 10 is the worst pain.

Time frame: from initial administration of PAIN study prehospital analgesia through hospital arrival

24 hour opioid use

total 24 hour opioid use

Time frame: from initial administration of PAIN study prehospital analgesia through 24 hours

Incidence of prehospital adverse events

Incidence of adverse events of allergic reaction, emergence, laryngospasm, dysphoria, pruritus, and nausea

Time frame: from initial administration of PAIN study prehospital analgesia through hospital arrival

Survival to hospital discharge

survival to hospital discharge

Time frame: administration of PAIN study prehospital analgesia through hospital discharge or death up to 30 days

Ventilator free days

ventilator free days. Ventilator days are defined as number of days recorded to the first decimal spent on a mechanical ventilator subtracted from 30

Time frame: from administration of PAIN study prehospital analgesia through hospital discharge or death up to 30 days

Intensive Care Unit free days

number of days recorded to the first decimal spent admitted to the Intensive Care Unit subtracted rom 30

Time frame: from administration of PAIN study prehospital analgesia through hospital discharge or death up to 30 days

Long term opioid use

long term opioid use assessed at 3 and 6 months. Patients who consent to further participation will be contacted to determine if they continued to use opioids (yes/no) at 3 and 6 months following trauma admission

Time frame: 3 months (+/- 1 month) and 6 months (+/- 1 month) following trauma admission

Hospital length of stay

number of days recorded to the first decimal from hospital admission to discharge up to 30 days

Time frame: from time of hospital admission to discharge

Baseline Pain/Anxiety/PTSD screening

A subset of patients who consent to further participation will be assessed for Anxiety/PTSD using the Four-Item Patient Health Questionnaire (PHQ-4) for anxiety and depression, a two item pain severity scale (0=no pain to 10=worst pain), and the Injured Trauma Survivor Screen (ITSS)

Time frame: 0 hours to 2 weeks from time of hospital admission

Long term (6 month) outcome

A subset of patients who consent to further participation will be assessed for anxiety/depression/PTSD symptoms using the following tools: Generalized Anxiety Disorder (GAD-7), 8 item Patient Health Questionnaire (PHQ-8), and 8 item PTSD checklist (PCL-5)

Time frame: 6 months +/- 1 month following trauma admission

Long Term Pain Assessment

A subset of patients who consent to further participation will be assessed for long term pain using a modified Brief Pain Inventory (numerical scale rating 0-10)

Time frame: At 3 and 6 months (+/- 1 month) after hospital arrival