Low Dose Ketamine for Blunt Thoracic Trauma

Blunt Injury of Thorax Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06236113
• Other study ID #: 04/18/46
• Status: Completed
• Phase: Phase 4
• Start date: October 1, 2021
• Est. completion date: June 26, 2023

Study information

• Verified date: May 2024
• Source: North Memorial Health Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 26, 2023
• Est. primary completion date: March 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blunt Injury of Thorax
• Rib Fractures
• Thoracic Injuries
• Wounds, Nonpenetrating

Intervention

Drug:
• Ketamine 1 Mg/mL-NaCl 0.9% Intravenous Solution
administered at rate of 0.1 mg/kg/hr

Locations

Country	Name	City	State
United States	North Memorial Health Hospital	Robbinsdale	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
North Memorial Health Care

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)

External Links

•   Description of conversion factors for opioid narcotics to express potency relative to morphine.