Blunt Injury of Thorax, Multiple Rib Fractures, Involving Three Ribs
Conditions
Keywords
Blunt Thoracic Trauma
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.
Interventions
DRUGKetamine 1 Mg/mL-NaCl 0.9% Intravenous Solution
administered at rate of 0.1 mg/kg/hr
Sponsors
North Memorial Health Care
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Pharmacist prepares medications for patients. Medication or placebo appear identical and are released to bedside nurse with weight based infusion instructions.
Intervention model description
prospective, randomized, double-blinded, placebo-controlled study comparing saline infusion with low-dose ketamine versus saline infusion alone.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Ketamine 1 Mg/mL-NaCl 0.9% Intravenous Solution: administered at rate of 0.1 mg/kg/hr | 25 |
| 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).
Ketamine 1 Mg/mL-NaCl 0.9% Intravenous Solution: administered at rate of 0.1 mg/kg/hr | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Placebo/Control | Low Dose Ketamine Infusion (LDKI) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 8 Participants | 20 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 17 Participants | 30 Participants |
| Age, Continuous | 64.8 years STANDARD_DEVIATION 11.2 | 57.6 years STANDARD_DEVIATION 14.8 | 62.8 years STANDARD_DEVIATION 13.5 |
| Average number fractured ribs | 5.7 Number of fractured ribs STANDARD_DEVIATION 1.9 | 7.1 Number of fractured ribs STANDARD_DEVIATION 3.8 | 6.3 Number of fractured ribs STANDARD_DEVIATION 3 |
| Injury Severity Score (ISS) | 11.4 Units on a scale STANDARD_DEVIATION 3.2 | 15.1 Units on a scale STANDARD_DEVIATION 5.1 | 13.0 Units on a scale STANDARD_DEVIATION 4.5 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 8 Participants | 5 Participants | 13 Participants |
| Sex: Female, Male Male | 17 Participants | 20 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 11 / 25 | 9 / 25 |
| serious Total, serious adverse events | 1 / 25 | 1 / 25 |
Outcome results
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.
Time frame: 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.
Population: The Utah opioid morphine milligram equivalent conversion factor was used to convert all opioid analgesic doses administered during the study period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo/Control | Milligrams of Morphine Equivalents (MME) Administered | 84.9 Morphine Milligam Equivalents (MME) | Standard Deviation 31.9 |
| Low Dose Ketamine Infusion (LDKI) | Milligrams of Morphine Equivalents (MME) Administered | 81.7 Morphine Milligam Equivalents (MME) | Standard Deviation 32.4 |
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.
Time frame: Up to 30 days after intervention (administration of study drug)
Population: Unplanned intensive care unit (ICU) admission or hospital readmission for a condition related to rib fractures/chest trauma.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo/Control | ICU Admission or Hospital Readmission | ICU Readmission within 30 days | 2 Participants |
| Placebo/Control | ICU Admission or Hospital Readmission | Hospital Readmission within 30 days | 3 Participants |
| Placebo/Control | ICU Admission or Hospital Readmission | No need for hospital or ICU readmission | 20 Participants |
| Low Dose Ketamine Infusion (LDKI) | ICU Admission or Hospital Readmission | ICU Readmission within 30 days | 0 Participants |
| Low Dose Ketamine Infusion (LDKI) | ICU Admission or Hospital Readmission | Hospital Readmission within 30 days | 1 Participants |
| Low Dose Ketamine Infusion (LDKI) | ICU Admission or Hospital Readmission | No need for hospital or ICU readmission | 23 Participants |
Secondary
Pulmonary Complications
Number of participants that develop pneumonia, require intubation, or non-invasive positive pressure ventilation
Time frame: Up to 30 days after intervention (administration of study drug)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo/Control | Pulmonary Complications | Develop pneumonia | 3 Participants |
| Placebo/Control | Pulmonary Complications | Require non-invasive positive pressure ventilation | 8 Participants |
| Placebo/Control | Pulmonary Complications | Require intubation | 1 Participants |
| Placebo/Control | Pulmonary Complications | No pulmonary complications | 13 Participants |
| Low Dose Ketamine Infusion (LDKI) | Pulmonary Complications | No pulmonary complications | 14 Participants |
| Low Dose Ketamine Infusion (LDKI) | Pulmonary Complications | Develop pneumonia | 0 Participants |
| Low Dose Ketamine Infusion (LDKI) | Pulmonary Complications | Require intubation | 1 Participants |
| Low Dose Ketamine Infusion (LDKI) | Pulmonary Complications | Require non-invasive positive pressure ventilation | 9 Participants |