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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WITHDRAWN
EARLY_PHASE1
INTERVENTIONAL
2023-01-01
2026-01-01
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
QUADRUPLE
Study Groups
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Treatment
Intranasal Ketamine
Ketamine
Treatment arm
Control
Normal Saline
Placebo
Control arm
Interventions
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Ketamine
Treatment arm
Placebo
Control arm
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients that received Ketamine in the field
* Patients less than 18 years old or greater than 80 years
* Pregnant or breast-feeding females
* Hemodynamic instability defined as need for vasoactive drugs or Systolic blood pressure \>180
* Weight less than 80 pounds or greater than 300 pounds
* Glasgow Coma Scale less than 15
* Current acute head injury resulting in unconsciousness
* Current or history of eye injury
* Current or history of seizures
* Facial or nasal fractures that require nasal precautions
* Current or history of intracranial hypertension
* History of Schizophrenia
* BAC (Blood Alcohol Content) greater than 0.08
* Current alcohol abuse
* Current drug abuse or positive drug screen
* Chronic pain or patients on pain contracts
* Inability to assess pain intensity
* Contraindications or allergies to the treatment
* Patients with hepatic insufficiency
* Prisoners
* Nursing home residents
* Urine drug screen positive for illicit drugs or medications not on their home medication list.
* BAC \> 0.08
* Positive pregnancy test
18 Years
80 Years
ALL
No
Sponsors
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Sanford Health
OTHER
Responsible Party
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Other Identifiers
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SH Briggs IN Ketamine
Identifier Type: -
Identifier Source: org_study_id
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