Scheduled Intranasal Ketamine

Pain Clinical Trial

— SINK  

Official title:

Effects of Opioid Requirements With Scheduled Intranasal Ketamine During Admission for Traumatic Pain

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05671913
• Other study ID #: SH Briggs IN Ketamine
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: January 1, 2023
• Est. completion date: January 1, 2026

Study information

• Verified date: April 2023
• Source: Sanford Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 1, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Trauma

Intervention

Drug:
• Ketamine
Treatment arm
• Placebo
Control arm

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanford Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Morphine Equivalents (TME) throughout hospitalization	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.	72 hours