Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
994 participants
INTERVENTIONAL
2023-11-27
2029-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Ketamine Hydrochloride
ketamine hydrochloride 2.5mg/ml packaged in pre-filled syringe
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.
Fentanyl Citrate
fentanyl citrate 10mcg/ml packaged in pre-filled syringe
Interventions
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Ketamine Hydrochloride
ketamine hydrochloride 2.5mg/ml packaged in pre-filled syringe
Fentanyl Citrate
fentanyl citrate 10mcg/ml packaged in pre-filled syringe
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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United States Department of Defense
FED
Jason Sperry
OTHER
Responsible Party
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Jason Sperry
Professor
Principal Investigators
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Jason Sperry, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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University of California, San Diego
San Diego, California, United States
Zuckerberg San Francisco General Hospital
San Francisco, California, United States
Cooper University Health Care
Camden, New Jersey, United States
Atrium Health and Carolinas Medical Center
Charlotte, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Allegheny Health Network (AHN) Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Guthrie Robert Packer Hospital
Sayre, Pennsylvania, United States
University of Utah
Salt Lake City, Utah, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HT94252430002
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
STUDY22010164
Identifier Type: -
Identifier Source: org_study_id