Prehospital Analgesia INtervention Trial (PAIN)

Part of paid clinical trials in San Diego, California.

Sponsor
Jason Sperry
Study ID
NCT05437575
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Traumatic Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Nov 27, 2023
Status verified
Mar 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2029

Study Design

Enrollment
994 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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 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.
  • 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 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.

Primary Outcome Measure

24-hour mortality [ Time Frame: trauma bay arrival through 24 hours ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
University of California, San DiegoSan DiegoCalifornia92103
Laura Haines, MD
[email protected]
619-543-7200
Zuckerberg San Francisco General HospitalSan FranciscoCalifornia94110
Lucy Kornblith, MD
[email protected]
415-609-6924
Cooper University Health CareCamdenNew Jersey08103
Tanya Egodage
[email protected]
856-342-3341
Atrium Health and Carolinas Medical CenterCharlotteNorth Carolina28203
Addison May, MD
[email protected]
704 446-2504
University of CincinnatiCincinnatiOhio45267
Jason McMullan, MD
[email protected]
513-675-3072
Allegheny Health Network (AHN) Allegheny General HospitalPittsburghPennsylvania15212
Philip Nawrocki, MD
[email protected]
4124876590
University of PittsburghPittsburghPennsylvania15213
Jason Sperry, MD
[email protected]
412-647-3065
Jason Sperry, MD (PRINCIPAL_INVESTIGATOR)
Guthrie Robert Packer HospitalSayrePennsylvania18840
Jon Rittenberger, MD
[email protected]
570-887-4318
University of UtahSalt Lake CityUtah84132
Scott Youngquist, MD
[email protected]
The University of Vermont Larner College of MedicineBurlingtonVermont05405
Daniel Wolfson, MD, FACEP, FAEMS
[email protected]
802-847-2434
Medical College of WisconsinMilwaukeeWisconsin53266-

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By research site
University of California, San Diego· San Diego, CAZuckerberg San Francisco General Hospital· San Francisco, CACooper University Health Care· Camden, NJAtrium Health and Carolinas Medical Center· Charlotte, NCUniversity of Cincinnati· Cincinnati, OHAllegheny Health Network (AHN) Allegheny General Hospital· Pittsburgh, PA

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