Prehospital Analgesia INtervention Trial (PAIN)
Study Details
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 1,544 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
Drug: Ketamine Hydrochloride
ketamine hydrochloride 2.5mg/ml packaged in pre-filled syringe
|
| 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 |
Drug: Fentanyl Citrate
fentanyl citrate 10mcg/ml packaged in pre-filled syringe
|
Outcome Measures
Primary Outcome Measures
- 24-hour mortality [administration of prehospital analgesia through 24 hours]
All cause mortality within 24 hours of administration of prehospital analgesia
Secondary Outcome Measures
- Hypoxia [from initial administration of prehospital analgesia through hospital arrival]
incidence of hypoxia in the prehospital environment
- Hypotension [from initial administration of prehospital analgesia through hospital arrival]
incidence of hypotension in the prehospital environment
- Need for airway management [from initial administration of prehospital analgesia through hospital arrival]
need for airway management in the prehospital environment
- Prehospital pain assessment following analgesia [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 [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 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 prehospital analgesia through 24 hours]
total 24 hour opioid use
- Incidence of prehospital adverse events [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 [administration of prehospital analgesia through hospital discharge or death up to 30 days]
survival to hospital discharge
- Ventilator free days [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 [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 [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 [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 [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 [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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Pittsburgh | Pittsburgh | Pennsylvania | United States | 15213 |
Sponsors and Collaborators
- Jason Sperry
- United States Department of Defense
Investigators
- Principal Investigator: Jason Sperry, MD, University of Pittsburgh
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY22010164
- W81XWH- 6-D-0024