Low Dose Ketamine for Blunt Thoracic Trauma

Low Dose Ketamine for Blunt Thoracic Trauma: A Prospective Randomized Trial

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.

Study Overview

• Status: Completed
• Conditions: Blunt Injury of Thorax; Multiple Rib Fractures, Involving Three Ribs
• Intervention / Treatment: Drug: Ketamine 1 Mg/mL-NaCl 0.9% Intravenous Solution

Detailed Description

Study Design: Randomized controlled double-blinded trial: Patients will then be randomized into one of two study groups. Both groups will receive a normal saline infusion for 48 hours of therapy. The treatment group will have ketamine added to their saline infusion via blinded pharmacy protocol to receive continuous infusion of ketamine at 0.1mg/kg/hour. The control group will receive only normal saline. Administration will occur via piggyback infusion in accordance with nursing policy.

Setting/Participants:

• North Memorial Health Hospital: patients on 5-South - Trauma Neuro Intensive Care Unit (TNICU) and 6-West - Trauma Floor
• 50 people will take part in this study. 25 study subjects will receive an infusion of ketamine and 25 will receive a saline infusion.
• Patients 18 years of age or older with 3 or more rib fractures admitted to North Memorial Health Hospital will be considered for the study.

Study Interventions and Measures:

• Ketamine low-dose infusion administered at 0.1 mg/kg/hr for 48 hours as an adjunct to standardized rib fracture management interventions as outlined in facility-approved Guidelines for Rib Fracture Management.
• The primary study outcome will be amount of narcotic used over the 48-hour study period (expressed as morphine mg equivalents).
• Secondary outcome measures will include: need for endotracheal intubation or non-invasive positive pressure ventilation, oxygen requirements, daily incentive spirometer values, daily forced vital capacity measurements, and subjective patient pain ratings.
• Other outcomes measured will be Intensive Care Unit stay, total hospital length of stay, and adverse medication effects.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Robbinsdale, Minnesota, United States, 55422
      • North Memorial Health Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo/Control; 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; administered at rate of 0.1 mg/kg/hr; Other Names: Low Dose Ketamine Infusion; Ketamine Drip
Experimental: Low Dose Ketamine Infusion (LDKI); 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; administered at rate of 0.1 mg/kg/hr; Other Names: Low Dose Ketamine Infusion; Ketamine Drip

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine Mg Equivalents	Standardized method of reporting narcotic analgesic administration	Time zero up to 48 hours of infusion, plus up to 48 hours after infusion stops

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary complications	Number of participants that develop pneumonia, require intubation, or non-invasive positive pressure ventilation	Up to 30 days after intervention (administration of study drug)
ICU admission or hospital readmission	Number of participants that requirie transfer to ICU (e.g., respiratory difficulty, tachycardia, hypotension, altered mental status) or that readmission to hospital after discharge for any reason.	Up to 30 days after intervention (administration of study drug)

Collaborators and Investigators

• Sponsor: North Memorial Health Care
• Investigators: Study Director: Michaela A West, MD, PhD, North Memorial Health; Principal Investigator: Joseph Farhat, MD, North Memorial Health

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): March 19, 2023
• Study Completion (Actual): June 26, 2023

Study Registration Dates

• First Submitted: January 12, 2024
• First Submitted That Met QC Criteria: January 23, 2024
• First Posted (Actual): February 1, 2024

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Blunt Thoracic Trauma
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Thoracic Injuries; Rib Fractures; Wounds, Nonpenetrating; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: 04/18/46

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: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes