Scheduled Intranasal Ketamine (SINK)

Sanford Health

Status and phase

Withdrawn

Early Phase 1

Conditions

Trauma

Pain

Treatments

Drug: Placebo

Drug: Ketamine

Study type

Interventional

Funder types

Other

Identifiers

NCT05671913

SH Briggs IN Ketamine

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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 intubated
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