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Prehospital Analgesia INtervention Trial (PAIN) (PAIN)

Primary Purpose

Traumatic Injury

Status
Not yet recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ketamine Hydrochloride
Fentanyl Citrate
Sponsored by
Jason Sperry
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Injury focused on measuring Trauma, ketamine hydrochloride, fentanyl citrate, shock, pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Trauma activation (Level I or Level II) and transport from the scene of injury to a participating LITES Trauma center
  • Patient with compensated shock as defined by Shock Index (SI) >0.9
  • Intravenous pain medication indicated (CPOT>2, NRS>5)

Exclusion Criteria:

  • No IV access
  • Age <18 years
  • Females <50 years of age
  • SBP>180 mmHg
  • Received pain medication prior to enrollment
  • Advanced airway management prior to first dose administration
  • Known allergy to fentanyl citrate or ketamine hydrochloride
  • Prisoner
  • Objection to study voiced by subject or family member at scene
  • Pain treatment contraindicated by local protocol
  • Wearing a "NO PAIN" bracelet

Sites / Locations

  • University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ketamine Hydrochloride

Fentanyl Citrate

Arm Description

2 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 15 minutes if indication for pain management remains and there are no adverse events

2 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 15 minutes if indication for pain management remains and there are no adverse events

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Hypoxia
incidence of hypoxia in the prehospital environment
Hypotension
incidence of hypotension in the prehospital environment
Need for airway management
need for airway management in the prehospital environment
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.
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.
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.
24 hour opioid use
total 24 hour opioid use
Incidence of prehospital adverse events
Incidence of adverse events of allergic reaction, emergence, laryngospasm, dysphoria, pruritus, and nausea
Survival to hospital discharge
survival to hospital discharge
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
Intensive Care Unit free days
number of days recorded to the first decimal spent admitted to the Intensive Care Unit subtracted rom 30
Long term opioid use
long term opioid use assessed at 6 months. Patients who consent to further participation will be contacted by phone to determine if they continued to use opioids (yes/no) at 6 months following trauma admission
Hospital length of stay
number of days recorded to the first decimal from hospital admission to discharge up to 30 days
Anxiety/PTSD screening
Anxiety/PTSD screening using Primary Care Post Traumatic Stress Disorder Screen (PC-PTSD). Primary Care PTSD Screen is a 5-item screen measures probable PTSD on a scale of 0 to 5 where 0 is no exposure to trauma and 5 is exposure to trauma. Total score is a sum of "yes" responses to five questions about how trauma has affected the patient in the past month.
Long term (6 month) outcome
A subset of patients who consent to further participation will be assessed for PTSD symptoms by phone using Clinically Administered Post Traumatic Stress Disorder Scale (CAPS), Post Traumatic Stress Disorder Checklist Military (PCL-M). The CAPS is a 30 item structured interview to assess PTSD in the past week, month, and lifetime. Individual item severity scores are summed by cluster with each item given a score on a scale of 0 to 4, where 0 is absent and 4 is extreme. The PCL-M checklist is a self report measure that assesses symptoms of PTSD on a scale of 1 to 5, where 1 is not at all and 5 is extremely affected

Full Information

First Posted
May 24, 2022
Last Updated
September 6, 2023
Sponsor
Jason Sperry
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT05437575
Brief Title
Prehospital Analgesia INtervention Trial (PAIN)
Acronym
PAIN
Official Title
Prehospital Analgesia INtervention Trial (PAIN)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jason Sperry
Collaborators
United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 1,136 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Injury
Keywords
Trauma, ketamine hydrochloride, fentanyl citrate, shock, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
1544 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ketamine Hydrochloride
Arm Type
Experimental
Arm Description
2 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 15 minutes if indication for pain management remains and there are no adverse events
Arm Title
Fentanyl Citrate
Arm Type
Active Comparator
Arm Description
2 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 15 minutes if indication for pain management remains and there are no adverse events
Intervention Type
Drug
Intervention Name(s)
Ketamine Hydrochloride
Intervention Description
ketamine hydrochloride 2.5mg/ml packaged in pre-filled syringe
Intervention Type
Drug
Intervention Name(s)
Fentanyl Citrate
Intervention Description
fentanyl citrate 10mcg/ml packaged in pre-filled syringe
Primary Outcome Measure Information:
Title
24-hour mortality
Description
All cause mortality within 24 hours from time of trauma bay arrival
Time Frame
trauma bay arrival through 24 hours
Secondary Outcome Measure Information:
Title
Hypoxia
Description
incidence of hypoxia in the prehospital environment
Time Frame
from initial administration of prehospital analgesia through hospital arrival
Title
Hypotension
Description
incidence of hypotension in the prehospital environment
Time Frame
from initial administration of prehospital analgesia through hospital arrival
Title
Need for airway management
Description
need for airway management in the prehospital environment
Time Frame
from initial administration of prehospital analgesia through hospital arrival
Title
Prehospital pain assessment following analgesia
Description
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 prehospital analgesia through hospital arrival
Title
Trauma bay arrival pain score
Description
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.
Time Frame
score assessed at time of arrival to trauma bay
Title
Number of analgesic doses necessary to reduce pain level to <5 NRS or CPOT less than 2
Description
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 prehospital analgesia through hospital arrival
Title
24 hour opioid use
Description
total 24 hour opioid use
Time Frame
from initial administration of prehospital analgesia through 24 hours
Title
Incidence of prehospital adverse events
Description
Incidence of adverse events of allergic reaction, emergence, laryngospasm, dysphoria, pruritus, and nausea
Time Frame
from initial administration of prehospital analgesia through hospital arrival
Title
Survival to hospital discharge
Description
survival to hospital discharge
Time Frame
administration of prehospital analgesia through hospital discharge or death up to 30 days
Title
Ventilator free days
Description
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 prehospital analgesia through hospital discharge or death up to 30 days
Title
Intensive Care Unit free days
Description
number of days recorded to the first decimal spent admitted to the Intensive Care Unit subtracted rom 30
Time Frame
from administration of prehospital analgesia through hospital discharge or death up to 30 days
Title
Long term opioid use
Description
long term opioid use assessed at 6 months. Patients who consent to further participation will be contacted by phone to determine if they continued to use opioids (yes/no) at 6 months following trauma admission
Time Frame
6 months following trauma admission
Title
Hospital length of stay
Description
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
Title
Anxiety/PTSD screening
Description
Anxiety/PTSD screening using Primary Care Post Traumatic Stress Disorder Screen (PC-PTSD). Primary Care PTSD Screen is a 5-item screen measures probable PTSD on a scale of 0 to 5 where 0 is no exposure to trauma and 5 is exposure to trauma. Total score is a sum of "yes" responses to five questions about how trauma has affected the patient in the past month.
Time Frame
at 72 hours from time of hospital admission
Title
Long term (6 month) outcome
Description
A subset of patients who consent to further participation will be assessed for PTSD symptoms by phone using Clinically Administered Post Traumatic Stress Disorder Scale (CAPS), Post Traumatic Stress Disorder Checklist Military (PCL-M). The CAPS is a 30 item structured interview to assess PTSD in the past week, month, and lifetime. Individual item severity scores are summed by cluster with each item given a score on a scale of 0 to 4, where 0 is absent and 4 is extreme. The PCL-M checklist is a self report measure that assesses symptoms of PTSD on a scale of 1 to 5, where 1 is not at all and 5 is extremely affected
Time Frame
6 months following trauma admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Trauma activation and transport from the scene of 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 Exclusion Criteria: No IV access Age <18 years Females <50 years of age SBP>180 mmHg at time of enrollment Received pain medication prior to 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jason Sperry, MD
Phone
412-802-8270
Email
sperryjl@upmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Sperry, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Sperry, MD
Phone
412-647-3065
Email
sperryjl@upmc.edu
First Name & Middle Initial & Last Name & Degree
Jason Sperry, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data may be shared with the funding agency as well as other researchers upon request to the Principal Investigator
IPD Sharing Time Frame
Data will become available after publication of the primary manuscript
IPD Sharing Access Criteria
Requests for data will be submitted in writing and reviewed by the Principal Investigator.

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Prehospital Analgesia INtervention Trial (PAIN)

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