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Prehospital Analgesia INtervention Trial (PAIN) (PAIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05437575
Recruitment Status : Not yet recruiting
First Posted : June 29, 2022
Last Update Posted : June 29, 2022
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Jason Sperry, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE May 24, 2022
First Posted Date  ICMJE June 29, 2022
Last Update Posted Date June 29, 2022
Estimated Study Start Date  ICMJE September 2022
Estimated Primary Completion Date September 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2022)
24-hour mortality [ Time Frame: administration of prehospital analgesia through 24 hours ]
All cause mortality within 24 hours of administration of prehospital analgesia
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2022)
  • Hypoxia [ Time Frame: from initial administration of prehospital analgesia through hospital arrival ]
    incidence of hypoxia in the prehospital environment
  • Hypotension [ Time Frame: from initial administration of prehospital analgesia through hospital arrival ]
    incidence of hypotension in the prehospital environment
  • Need for airway management [ Time Frame: from initial administration of prehospital analgesia through hospital arrival ]
    need for airway management in the prehospital environment
  • Prehospital pain assessment following analgesia [ Time Frame: from initial administration of prehospital analgesia through hospital arrival ]
    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 [ Time Frame: score assessed at time of arrival to trauma bay ]
    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 [ Time Frame: from initial administration of prehospital analgesia through hospital arrival ]
    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 [ Time Frame: from initial administration of prehospital analgesia through 24 hours ]
    total 24 hour opioid use
  • Incidence of prehospital adverse events [ Time Frame: from initial administration of prehospital analgesia through hospital arrival ]
    Incidence of adverse events of allergic reaction, emergence, laryngospasm, dysphoria, pruritus, and nausea
  • Survival to hospital discharge [ Time Frame: administration of prehospital analgesia through hospital discharge or death up to 30 days ]
    survival to hospital discharge
  • Ventilator free days [ Time Frame: from administration of prehospital analgesia through hospital discharge or death up to 30 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 [ Time Frame: from administration of prehospital analgesia through hospital discharge or death up to 30 days ]
    number of days recorded to the first decimal spent admitted to the Intensive Care Unit subtracted rom 30
  • Long term opioid use [ Time Frame: 6 months following trauma admission ]
    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 [ Time Frame: from time of hospital admission to discharge ]
    number of days recorded to the first decimal from hospital admission to discharge up to 30 days
  • Anxiety/PTSD screening [ Time Frame: at 72 hours from time of hospital admission ]
    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) PTSD outcome [ Time Frame: 6 months following trauma admission ]
    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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prehospital Analgesia INtervention Trial (PAIN)
Official Title  ICMJE Prehospital Analgesia INtervention Trial (PAIN)
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 1,544 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Traumatic Injury
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Ketamine Hydrochloride
    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
    Intervention: Drug: Ketamine Hydrochloride
  • Active Comparator: Fentanyl Citrate
    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: Drug: Fentanyl Citrate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 24, 2022)
1544
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2026
Estimated Primary Completion Date September 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jason Sperry, MD 412-802-8270 sperryjl@upmc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05437575
Other Study ID Numbers  ICMJE STUDY22010164
W81XWH- 6-D-0024 ( Other Grant/Funding Number: Department of Defense )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified data may be shared with the funding agency as well as other researchers upon request to the Principal Investigator
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Data will become available after publication of the primary manuscript
Access Criteria: Requests for data will be submitted in writing and reviewed by the Principal Investigator.
Current Responsible Party Jason Sperry, University of Pittsburgh
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Jason Sperry
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE United States Department of Defense
Investigators  ICMJE
Principal Investigator: Jason Sperry, MD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP