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NCT Number: NCT05437575

Prehospital Analgesia INtervention Trial (PAIN)

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of California, San Diego, San Diego, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketamine Hydrochloride

Drug

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

Fentanyl Citrate

Drug

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

Primary outcomes

  1. 24-hour mortality

    Time frame: trauma bay arrival through 24 hours

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

Secondary outcomes

  1. Hypoxia

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

    incidence of hypoxia in the prehospital environment

  2. Hypotension

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

    incidence of hypotension in the prehospital environment

  3. Need for airway management

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

    need for airway management in the prehospital environment

  4. Prehospital pain assessment following analgesia

    Time frame: from initial administration of PAIN study 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.

  5. 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.

  6. 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

    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.

  7. 24 hour opioid use

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

    total 24 hour opioid use

  8. Incidence of prehospital adverse events

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

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

  9. Survival to hospital discharge

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

    survival to hospital discharge

  10. Ventilator free days

    Time frame: from administration of PAIN study 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

  11. Intensive Care Unit free days

    Time frame: from administration of PAIN study 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

  12. Long term opioid use

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

    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

  13. 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

  14. Baseline Pain/Anxiety/PTSD screening

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

    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)

  15. Long term (6 month) outcome

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

    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)

  16. Long Term Pain Assessment

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

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Jason Sperry, MD

CONTACT

[email protected]

412-802-8270

Sponsors and collaborators

Lead sponsor

Jason Sperry

Other

Collaborators

  • United States Department of Defense

Registry information

Acronym: PAIN

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Jun 29, 2022
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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