Scheduled Intranasal Ketamine

NCT ID: NCT05671913

Last Updated: 2023-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

EARLY_PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2026-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain Trauma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment

Intranasal Ketamine

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

Treatment arm

Control

Normal Saline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Control arm

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ketamine

Treatment arm

Intervention Type DRUG

Placebo

Control arm

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sanford Health

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SH Briggs IN Ketamine

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Nasal Human Abuse Potential of PTI-821
NCT03475862 COMPLETED PHASE1
Ketamine for Opioid Use Disorder
NCT06943859 RECRUITING PHASE2
Opiate Suicide Study in Patients With Major Depression
NCT04116528 ACTIVE_NOT_RECRUITING PHASE3
Suvorexant for Opioid/Stimulant Co-use
NCT05546515 COMPLETED PHASE2