Clinical trial NCT05437575: Prehospital Analgesia INtervention Trial (PAIN)
Official title: Prehospital Analgesia INtervention Trial (PAIN)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Traumatic Injury
Keywords: Trauma
ketamine hydrochloride
fentanyl citrate
shock
pain
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2022-06-29
Enrollment: 994
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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) and an indication for pain management, comparing patient centered outcomes following prehospital administration of ketamine hydrochloride versus fentanyl citrate.


Eligibility criteria: Inclusion Criteria:

* Transport after injury to a participating PAIN Trauma center
* Patient with compensated shock as defined by Shock Index (SI) ≥0.9
* 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

Primary outcomes:
measure: 24-hour mortality
timeFrame: trauma bay arrival through 24 hours
Secondary outcomes:
measure: Hypoxia
timeFrame: from initial administration of PAIN prehospital analgesia through hospital arrival
measure: Hypotension
timeFrame: from initial administration of PAIN study prehospital analgesia through hospital arrival
measure: Need for airway management
timeFrame: from initial administration of PAIN study prehospital analgesia through hospital arrival
measure: Prehospital pain assessment following analgesia
timeFrame: from initial administration of PAIN study prehospital analgesia through hospital arrival
measure: Trauma bay arrival pain score
timeFrame: score assessed at time of arrival to trauma bay
measure: Number of analgesic doses necessary to reduce pain level to <5 NRS or CPOT less than 2
timeFrame: from initial administration of PAIN study prehospital analgesia through hospital arrival
measure: 24 hour opioid use
timeFrame: from initial administration of PAIN study prehospital analgesia through 24 hours
measure: Incidence of prehospital adverse events
timeFrame: from initial administration of PAIN study prehospital analgesia through hospital arrival
measure: Survival to hospital discharge
timeFrame: administration of PAIN study prehospital analgesia through hospital discharge or death up to 30 days
measure: Ventilator free days
timeFrame: from administration of PAIN study prehospital analgesia through hospital discharge or death up to 30 days
measure: Intensive Care Unit free days
timeFrame: from administration of PAIN study prehospital analgesia through hospital discharge or death up to 30 days
measure: Long term opioid use
timeFrame: 3 months (+/- 1 month) and 6 months (+/- 1 month) following trauma admission
measure: Hospital length of stay
timeFrame: from time of hospital admission to discharge
measure: Baseline Pain/Anxiety/PTSD screening
timeFrame: 0 hours to 2 weeks from time of hospital admission
measure: Long term (6 month) outcome
timeFrame: 6 months +/- 1 month following trauma admission
measure: Long Term Pain Assessment
timeFrame: At 3 and 6 months (+/- 1 month) after hospital arrival
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: Camden
country: United States
facility: Cooper University Health Care
state: New Jersey
city: Charlotte
country: United States
facility: Atrium Health and Carolinas Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Pittsburgh
country: United States
facility: Allegheny Health Network (AHN) Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Sayre
country: United States
facility: Guthrie Robert Packer Hospital
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Pittsburgh
name: Jason Sperry, MD
role: PRINCIPAL_INVESTIGATOR
References: