Scheduled Intranasal Ketamine

NCT05671913 | Withdrawn Early Phase 1

• 1 other identifier: SH Briggs IN Ketamine
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain; Trauma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Treatment

ACTIVE COMPARATOR

Intranasal Ketamine

Drug: Ketamine

Control

PLACEBO COMPARATOR

Normal Saline

Drug: Placebo

Interventions

Ketamine DRUG

Treatment arm

Treatment

Placebo DRUG

Control arm

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Sanford Health: lead

MeSH Terms

Conditions

Pain; Wounds and Injuries

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: January 5, 2023
• Study Start: January 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: January 1, 2026
• Last Updated: April 5, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share