Trial Outcomes & Findings for Low Dose Ketamine for Blunt Thoracic Trauma (NCT NCT06236113)
NCT ID: NCT06236113
Last Updated: 2024-05-21
Results Overview
Standardized method of reporting narcotic analgesic administration by converting opioid narcotics to the equivalent dosage of morphine that would yield same result.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
50 participants
Primary outcome timeframe
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.
Results posted on
2024-05-21
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Placebo/Control
n=25 Participants
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
|
Low Dose Ketamine Infusion (LDKI)
n=25 Participants
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
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=25 Participants
|
17 Participants
n=25 Participants
|
30 Participants
n=50 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=25 Participants
|
8 Participants
n=25 Participants
|
20 Participants
n=50 Participants
|
|
Age, Continuous
|
64.8 years
STANDARD_DEVIATION 11.2 • n=25 Participants
|
57.6 years
STANDARD_DEVIATION 14.8 • n=25 Participants
|
62.8 years
STANDARD_DEVIATION 13.5 • n=50 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=25 Participants
|
5 Participants
n=25 Participants
|
13 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=25 Participants
|
20 Participants
n=25 Participants
|
37 Participants
n=50 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
25 participants
n=25 Participants
|
25 participants
n=25 Participants
|
50 participants
n=50 Participants
|
|
Average number fractured ribs
|
5.7 Number of fractured ribs
STANDARD_DEVIATION 1.9 • n=25 Participants
|
7.1 Number of fractured ribs
STANDARD_DEVIATION 3.8 • n=25 Participants
|
6.3 Number of fractured ribs
STANDARD_DEVIATION 3.0 • n=50 Participants
|
|
Injury Severity Score (ISS)
|
11.4 Units on a scale
STANDARD_DEVIATION 3.2 • n=25 Participants
|
15.1 Units on a scale
STANDARD_DEVIATION 5.1 • n=25 Participants
|
13.0 Units on a scale
STANDARD_DEVIATION 4.5 • n=50 Participants
|
PRIMARY outcome
Timeframe: 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.
Standardized method of reporting narcotic analgesic administration by converting opioid narcotics to the equivalent dosage of morphine that would yield same result.
Outcome measures
| Measure |
Placebo/Control
n=25 Participants
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
|
Low Dose Ketamine Infusion (LDKI)
n=25 Participants
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
|
|---|---|---|
|
Milligrams of Morphine Equivalents (MME) Administered
|
84.9 Morphine Milligam Equivalents (MME)
Standard Deviation 31.9
|
81.7 Morphine Milligam Equivalents (MME)
Standard Deviation 32.4
|
SECONDARY outcome
Timeframe: Up to 30 days after intervention (administration of study drug)Number of participants that develop pneumonia, require intubation, or non-invasive positive pressure ventilation
Outcome measures
| Measure |
Placebo/Control
n=25 Participants
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
|
Low Dose Ketamine Infusion (LDKI)
n=24 Participants
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
|
|---|---|---|
|
Pulmonary Complications
Develop pneumonia
|
3 Participants
|
0 Participants
|
|
Pulmonary Complications
Require non-invasive positive pressure ventilation
|
8 Participants
|
9 Participants
|
|
Pulmonary Complications
Require intubation
|
1 Participants
|
1 Participants
|
|
Pulmonary Complications
No pulmonary complications
|
13 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo/Control
n=25 Participants
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
|
Low Dose Ketamine Infusion (LDKI)
n=24 Participants
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
|
|---|---|---|
|
ICU Admission or Hospital Readmission
ICU Readmission within 30 days
|
2 Participants
|
0 Participants
|
|
ICU Admission or Hospital Readmission
Hospital Readmission within 30 days
|
3 Participants
|
1 Participants
|
|
ICU Admission or Hospital Readmission
No need for hospital or ICU readmission
|
20 Participants
|
23 Participants
|
Adverse Events
Placebo/Control
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Low Dose Ketamine Infusion (LDKI)
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo/Control
n=25 participants at risk
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
|
Low Dose Ketamine Infusion (LDKI)
n=25 participants at risk
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
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory failure
|
4.0%
1/25 • Number of events 1 • Adverse events data were specifically analyzed for a time period within 30 days of initiation of study drug infusion.
|
4.0%
1/25 • Number of events 1 • Adverse events data were specifically analyzed for a time period within 30 days of initiation of study drug infusion.
|
Other adverse events
| Measure |
Placebo/Control
n=25 participants at risk
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
|
Low Dose Ketamine Infusion (LDKI)
n=25 participants at risk
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
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Non-serious adverse events
|
44.0%
11/25 • Number of events 11 • Adverse events data were specifically analyzed for a time period within 30 days of initiation of study drug infusion.
|
36.0%
9/25 • Number of events 9 • Adverse events data were specifically analyzed for a time period within 30 days of initiation of study drug infusion.
|
Additional Information
Michaela A West, MD, PhD
North Memorial Health Robbinsdale Hospital
Phone: 763-581-3704
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place