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| ID | Type | Description | Link |
|---|---|---|---|
| HT9425-25-F-0041 | Other Grant/Funding Number | Department of Defense |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine Hydrochloride | Experimental | 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 approximately 15 minutes if the subject has a qualifying pain score, there are no contraindications to pain medication per local protocol, and no exclusion criteria have been met. |
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| Fentanyl Citrate | Active Comparator | 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 approximately 15 minutes if the subject has a qualifying pain score, there are no contraindications to pain medication per local protocol, and no exclusion criteria have been met. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine Hydrochloride | Drug | ketamine hydrochloride 2.5mg/ml packaged in pre-filled syringe |
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| Measure | Description | Time Frame |
|---|---|---|
| 24-hour mortality | All cause mortality within 24 hours from time of trauma bay arrival | trauma bay arrival through 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Hypoxia | incidence of hypoxia in the prehospital environment | from initial administration of PAIN prehospital analgesia through hospital arrival |
| Hypotension | incidence of hypotension in the prehospital environment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jason Sperry, MD | Contact | 412-802-8270 | sperryjl@upmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jason Sperry, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | Recruiting | San Diego | California | 92103 | United States |
De-identified data may be shared with the funding agency as well as other researchers upon request to the Principal Investigator
Data will become available after publication of the primary manuscript
Requests for data will be submitted in writing and reviewed by the Principal Investigator.
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D012769 | Shock |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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Parallel Assignment
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| Fentanyl Citrate | Drug | fentanyl citrate 10mcg/ml packaged in pre-filled syringe |
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| from initial administration of PAIN study prehospital analgesia through hospital arrival |
| Need for airway management | need for airway management in the prehospital environment | 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. | 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. | 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. | from initial administration of PAIN study prehospital analgesia through hospital arrival |
| 24 hour opioid use | total 24 hour opioid use | 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 | from initial administration of PAIN study prehospital analgesia through hospital arrival |
| Survival to hospital discharge | survival to hospital discharge | 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 | 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 | 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 | 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 | 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) | 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) | 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) | At 3 and 6 months (+/- 1 month) after hospital arrival |
| Zuckerberg San Francisco General Hospital | Recruiting | San Francisco | California | 94110 | United States |
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| Cooper University Health Care | Recruiting | Camden | New Jersey | 08103 | United States |
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| Atrium Health and Carolinas Medical Center | Recruiting | Charlotte | North Carolina | 28203 | United States |
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| University of Cincinnati | Recruiting | Cincinnati | Ohio | 45267 | United States |
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| Allegheny Health Network (AHN) Allegheny General Hospital | Recruiting | Pittsburgh | Pennsylvania | 15212 | United States |
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| University of Pittsburgh | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
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| Guthrie Robert Packer Hospital | Recruiting | Sayre | Pennsylvania | 18840 | United States |
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| University of Utah | Recruiting | Salt Lake City | Utah | 84132 | United States |
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| The University of Vermont Larner College of Medicine | Recruiting | Burlington | Vermont | 05405 | United States |
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| Medical College of Wisconsin | Suspended | Milwaukee | Wisconsin | 53266 | United States |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |