Scheduled Intranasal Ketamine | NCT05671913

Studies
Scheduled Intranasal Ketamine

NCT05671913

Sponsor

Sanford Health

Status

Withdrawn

Last Update Posted

Apr 5, 2023Actual

Enrollment

0Actual

Phase

Early Phase 1

Conditions

Pain
Trauma

Interventions

Ketamine
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Funding not acquired to run the study.

Expanded Access Info

Start Date

Jan 1, 2023Estimated

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Jan 1, 2026Estimated

First Submitted Date

Jul 13, 2022

First Submission Date that Met QC Criteria

Jan 3, 2023

First Posted Date

Jan 5, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2023

Last Update Posted Date

Apr 5, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment	Active Comparator	Intranasal Ketamine	Drug: Ketamine
Control	Placebo Comparator	Normal Saline	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ketamine	Drug	Treatment arm	Treatment
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D014947	Wounds and Injuries

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D003510	Cyclohexanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic