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NCT05671913
Scheduled Intranasal Ketamine
Conditions: Pain, Trauma
Sex: All
Ages: 18 Years – 80 Years
Phase: EARLY_PHASE1
Enrollment: 200
Sponsor: Sanford Health
Summary
The purpose of this research is to determine if scheduled intranasal ketamine effects opioid requirements in adult trauma patients with moderate to severe pain in the inpatient setting.
Eligibility Criteria
Inclusion Criteria:Patient between aged 18-80 years, present following a traumatic incident, rate pain > 5 on the numeric rating scale (NSR), and require admission to the hospital.Exclusion Criteria:- Patients that arrive at facility intubatedPatients that received Ketamine in the fieldPatients less than 18 years old or greater than 80 yearsPregnant or breast-feeding femalesHemodynamic instability defined as need for vasoactive drugs or Systolic blood pressure >180Weight less than 80 pounds or greater than 300 poundsGlasgow Coma Scale less than 15Current acute head injury resulting in unconsciousnessCurrent or history of eye injuryCurrent or history of seizuresFacial or nasal fractures that require nasal precautionsCurrent or history of intracranial hypertensionHistory of SchizophreniaBAC (Blood Alcohol Content) greater than 0.08Current alcohol abuseCurrent drug abuse or positive drug screenChronic pain or patients on pain contractsInability to assess pain intensityContraindications or allergies to the treatmentPatients with hepatic insufficiencyPrisonersNursing home residentsUrine drug screen positive for illicit drugs or medications not on their home medication list.BAC > 0.08Positive pregnancy test
Source: ClinicalTrials.gov (NCT05671913). StuddyBuddy aggregates publicly available trial information.