Scheduled Intranasal Ketamine (SINK)

April 3, 2023 updated by: Sanford Health

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Normal Saline
Drug: Placebo
Control arm
Active Comparator: Treatment
Intranasal Ketamine
Drug: Ketamine
Treatment arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Morphine Equivalents (TME) throughout hospitalization
Time Frame: 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.
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanford Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2023

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

January 1, 2026

Study Registration Dates

First Submitted

July 13, 2022

First Submitted That Met QC Criteria

January 3, 2023

First Posted (Actual)

January 5, 2023

Study Record Updates

Last Update Posted (Actual)

April 5, 2023

Last Update Submitted That Met QC Criteria

April 3, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SH Briggs IN Ketamine

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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