Traumatic Injury
Conditions
Keywords
Trauma, ketamine hydrochloride, fentanyl citrate, shock, 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 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.
Interventions
DRUGKetamine Hydrochloride
ketamine hydrochloride 2.5mg/ml packaged in pre-filled syringe
DRUGFentanyl Citrate
fentanyl citrate 10mcg/ml packaged in pre-filled syringe
Sponsors
Jason Sperry
United States Department of Defense
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24-hour mortality | trauma bay arrival through 24 hours | All cause mortality within 24 hours from time of trauma bay arrival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypotension | from initial administration of PAIN study prehospital analgesia through hospital arrival | incidence of hypotension in the prehospital environment |
| Need for airway management | from initial administration of PAIN study prehospital analgesia through hospital arrival | need for airway management in the prehospital environment |
| Prehospital pain assessment following analgesia | 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. |
| Trauma bay arrival pain score | 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 | 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. |
| 24 hour opioid use | from initial administration of PAIN study prehospital analgesia through 24 hours | total 24 hour opioid use |
| Incidence of prehospital adverse events | from initial administration of PAIN study prehospital analgesia through hospital arrival | Incidence of adverse events of allergic reaction, emergence, laryngospasm, dysphoria, pruritus, and nausea |
| Survival to hospital discharge | administration of PAIN study prehospital analgesia through hospital discharge or death up to 30 days | survival to hospital discharge |
| Ventilator free days | 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 |
| Intensive Care Unit free days | 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 |
| Long term opioid use | 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 |
| Hospital length of stay | from time of hospital admission to discharge | number of days recorded to the first decimal from hospital admission to discharge up to 30 days |
| Baseline Pain/Anxiety/PTSD screening | 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) |
| Long term (6 month) outcome | 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) |
| Hypoxia | from initial administration of PAIN prehospital analgesia through hospital arrival | incidence of hypoxia in the prehospital environment |
| Long Term Pain Assessment | 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) |
Countries
United States
Contacts
CONTACTJason Sperry, MD
PRINCIPAL_INVESTIGATORJason Sperry, MD
University of Pittsburgh
Outcome results
None listed