Scheduled Intranasal Ketamine

Early Phase 1

Withdrawn

• Conditions: Trauma; Pain
• Interventions: Drug: Placebo; Drug: Ketamine

• Registration Number: NCT05671913
• Lead Sponsor: Sanford Health

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-13
• Study Start: 2023-01-01
• Study First Submitted QC: 2023-01-03
• Study First Posted: 2023-01-05
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-03
• Last Update Posted: 2023-04-05
• Primary Completion: 2025-12-31
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	Normal Saline
Treatment	Ketamine	Intranasal Ketamine

Primary Outcome Measures

Name	Time	Method
Total Morphine Equivalents (TME) throughout hospitalization	72 hours	Total Morphine Equivalents is a standardized way of measuring opioids that patients receive over time. This will be calculated by a member of the research study team utilizing a standardized formula under pharmacies direction. The Medication Administration Record (MAR) will be reviewed to gather administered doses of opioids throughout the participants hospital stay.