Low Dose Ketamine for Blunt Thoracic Trauma

Phase 4

Completed

Conditions: Blunt Injury of Thorax
Multiple Rib Fractures, Involving Three Ribs

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

Registration Number: NCT06236113

Lead Sponsor: North Memorial Health Care

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 50

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Dose Ketamine Infusion (LDKI)	Ketamine 1 Mg/mL-NaCl 0.9% Intravenous Solution	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).
Placebo/Control	Ketamine 1 Mg/mL-NaCl 0.9% Intravenous Solution	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.

Primary Outcome Measures

Name	Time	Method
Milligrams of Morphine Equivalents (MME) Administered	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.	Standardized method of reporting narcotic analgesic administration by converting opioid narcotics to the equivalent dosage of morphine that would yield same result.

Secondary Outcome Measures

Name	Time	Method
Pulmonary Complications	Up to 30 days after intervention (administration of study drug)	Number of participants that develop pneumonia, require intubation, or non-invasive positive pressure ventilation
ICU Admission or Hospital Readmission	Up to 30 days after intervention (administration of study drug)	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.