Low Dose Ketamine for Blunt Thoracic Trauma

NCT06236113 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 04/18/46
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this Randomized controlled double-blinded trial is to compare the addition of a ketamine infusion to placebo, when added to standard care in adult blunt trauma patients with multiple rib fractures. The main question it aims to answer are: • addition of low dose ketamine infusion (LDKI) decreases narcotic use • does LDKI impact pulmonary complications, readmission, or hospital length of stay Participants will receive usual standard of care with up to 48 hours of LDKI or placebo. If there is a comparison group: Researchers will compare infusion of a saline infusion to LDKI to see if LDKI decreases need for narcotic analgesics use.

Conditions

Blunt Injury of Thorax; Multiple Rib Fractures, Involving Three Ribs

Keywords

Blunt Thoracic Trauma

Outcome Measures

Primary Outcomes (1)

• Milligrams of Morphine Equivalents (MME) Administered

  Standardized method of reporting narcotic analgesic administration by converting opioid narcotics to the equivalent dosage of morphine that would yield same result.

  Outcome was evaluated up to a total of 96 hours (from time zero to 48 hours of infusion and up to 48 hrs after infusion stopped.

Secondary Outcomes (2)

• Pulmonary Complications

  Up to 30 days after intervention (administration of study drug)

• ICU Admission or Hospital Readmission

  Up to 30 days after intervention (administration of study drug)

Study Arms (2)

Placebo/Control

PLACEBO COMPARATOR

Pharmacist will check randomization schedule. For placebo/control subject they will prepare an infusion bag of saline with no added medication. The Study Drug Bag will be released with a label that includes: Name of Study, Study Subject #, Patient (Pt) Name, Pt Medical record number (MR#), Pt Date of birth (DOB), and INFUSION RATE.

Drug: Ketamine 1 Mg/mL-NaCl 0.9% Intravenous Solution

Low Dose Ketamine Infusion (LDKI)

EXPERIMENTAL

Infusion Bag will receive 100 mg of ketamine (Ketamine Infusion Subject). The Study Drug Bag will be released with a label that includes: Name of Study, Study Subject #, Patient Name, Pt MR#, Pt DOB, and INFUSION RATE. (Note: infusion rate is 0.1 mg/kg/hr and concentration of standard ketamine infusion bag is 1 mg/mL. That is, 100 mg of ketamine added to 100 mL saline).

Drug: Ketamine 1 Mg/mL-NaCl 0.9% Intravenous Solution

Interventions

Ketamine 1 Mg/mL-NaCl 0.9% Intravenous Solution DRUG

administered at rate of 0.1 mg/kg/hr

Also known as: Low Dose Ketamine Infusion, Ketamine Drip

Low Dose Ketamine Infusion (LDKI); Placebo/Control

Eligibility Criteria

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

You may qualify if:

• Males or females 18 years of age or older
• Diagnosis of 3 or more acute rib fractures related to blunt traumatic chest injury.
• Able to undergo consent procedure and give valid consent, or availability of family member to provide consent for the study

You may not qualify if:

• Age \<18 years
• Cognitively impaired
• Pregnant or lactating females.
• Glasgow Coma Score (GCS) of ≤ 14 at time of admission
• Evidence of increased intraocular pressure
• Presence of acute coronary syndrome
• Diagnosed moderate to severe traumatic brain injury
• Evidence of uncontrolled intracranial hypertension
• History of seizures or stroke
• History of severe psychiatric disorders
• Allergy to ketamine
• Currently being treated, prior to admission, with opiate agonist/antagonist therapy
• Presence of poorly controlled hypertension, cardiac arrhythmias, and/or tachycardia on admission
• Subjects who, in the opinion of the Investigator, may be inappropriate for study participation.

Sponsors & Collaborators

• North Memorial Health Care: lead

Study Sites (1)

North Memorial Health Hospital

Robbinsdale, Minnesota, 55422, United States

Location

Related Publications (1)

• Walters MK, Farhat J, Bischoff J, Foss M, Evans C. Ketamine as an Analgesic Adjuvant in Adult Trauma Intensive Care Unit Patients With Rib Fracture. Ann Pharmacother. 2018 Sep;52(9):849-854. doi: 10.1177/1060028018768451. Epub 2018 Apr 2.

  PMID: 29607659 BACKGROUND

MeSH Terms

Interventions

Ketamine

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Michaela A West, MD, PhD
• Organization: North Memorial Health Robbinsdale Hospital

Michaela.West@NorthMemorial.com

763-581-3704

Study Officials

• Michaela A West, MD, PhD

  North Memorial Health

  STUDY DIRECTOR

• Joseph Farhat, MD

  North Memorial Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Pharmacist prepares medications for patients. Medication or placebo appear identical and are released to bedside nurse with weight based infusion instructions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Trauma Research Chair

Model Details: prospective, randomized, double-blinded, placebo-controlled study comparing saline infusion with low-dose ketamine versus saline infusion alone.

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: February 1, 2024
• Study Start: October 1, 2021
• Primary Completion: March 19, 2023
• Study Completion: June 26, 2023
• Last Updated: May 21, 2024
• Results First Posted: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)