Trial Outcomes & Findings for Ketamine Infusion Therapy for the Management of Acute Pain in Adult Rib Fracture Patients (NCT NCT02432456)
NCT ID: NCT02432456
Last Updated: 2020-02-05
Results Overview
Visual Analog Numeric Pain scores are reported as a single numeric score between 0 and 10. The more severe the pain the higher the number with 10 representing the most severe pain imaginable.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
153 participants
Primary outcome timeframe
12-24 hours post infusion
Results posted on
2020-02-05
Participant Flow
Adult Study: From August 2015 to December of 2017, all adult blunt trauma patients with three or more rib fractures were screened for eligibility in this study. Elderly Study: From August 2015 to June 2018, all elderly blunt trauma patients with three or more rib fractures were screened for eligibility in the study.
153 patients agreed to participate. Three subjects (two from elderly and one from adult) were randomized but withdrawn prior to collecting any data or initiation of the infusions. This left a total of 150 participants within the trial, of which 75 were randomized to the placebo infusion with the other 75 randomized to the ketamine infusion.
Participant milestones
| Measure |
Placebo Infusion
Subjects in this arm received the institutional standard of care for rib fractures along with a placebo (NaCl) infusion.
|
Ketamine Infusion
Subjects in this arm will receive the institutional standard of care for rib fractures along with a ketamine infusion at a rate of 2.5 mcg/kg/min dosed based on ideal body weight.
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
75
|
|
Overall Study
COMPLETED
|
75
|
75
|
|
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 Infusion
n=75 Participants
Subjects in this arm received the institutional standard of care for rib fractures along with a placebo (NaCl) infusion.
|
Ketamine Infusion
n=75 Participants
Subjects in this arm will receive the institutional standard of care for rib fractures along with a ketamine infusion at a rate of 2.5 mcg/kg/min dosed based on ideal body weight.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=75 Participants
|
0 Participants
n=75 Participants
|
0 Participants
n=150 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
46 Participants
n=75 Participants
|
45 Participants
n=75 Participants
|
91 Participants
n=150 Participants
|
|
Age, Categorical
>=65 years
|
29 Participants
n=75 Participants
|
30 Participants
n=75 Participants
|
59 Participants
n=150 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=75 Participants
|
26 Participants
n=75 Participants
|
47 Participants
n=150 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=75 Participants
|
49 Participants
n=75 Participants
|
103 Participants
n=150 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
75 participants
n=75 Participants
|
75 participants
n=75 Participants
|
150 participants
n=150 Participants
|
|
BMI
Adult BMI
|
28.5 kg/m^2
n=46 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
29 kg/m^2
n=45 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
29 kg/m^2
n=91 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
|
BMI
Elderly BMI
|
26.8 kg/m^2
n=29 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
29.2 kg/m^2
n=30 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
27.7 kg/m^2
n=59 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
|
Number of Rib Fractures
Adult
|
6.4 Rib Fractures
STANDARD_DEVIATION 3.3 • n=46 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
6.4 Rib Fractures
STANDARD_DEVIATION 3.2 • n=45 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
6.4 Rib Fractures
STANDARD_DEVIATION 3.2 • n=91 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
|
Number of Rib Fractures
Elderly
|
6.5 Rib Fractures
STANDARD_DEVIATION 3.4 • n=29 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
6.1 Rib Fractures
STANDARD_DEVIATION 2.6 • n=30 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
6.3 Rib Fractures
STANDARD_DEVIATION 3.0 • n=59 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
|
Flail Chest
Adult
|
11 participants
n=46 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
15 participants
n=45 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
26 participants
n=91 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
|
Flail Chest
Elderly
|
9 participants
n=29 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
4 participants
n=30 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
13 participants
n=59 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
|
Injury Severity Score, median
Adult
|
13 Injury Severity Scale Score
n=46 Participants • Injury severity of each of 6 body systems is scored according the Abbreviated Injury Scale. Three body systems with the highest AIS scores are used to calculate the Injury Severity Score (ISS). These scores are squared and the results summed to produce the Injury Severity Score which ranges from 3-75. The higher the ISS the greater the injury.
|
17 Injury Severity Scale Score
n=45 Participants • Injury severity of each of 6 body systems is scored according the Abbreviated Injury Scale. Three body systems with the highest AIS scores are used to calculate the Injury Severity Score (ISS). These scores are squared and the results summed to produce the Injury Severity Score which ranges from 3-75. The higher the ISS the greater the injury.
|
14 Injury Severity Scale Score
n=91 Participants • Injury severity of each of 6 body systems is scored according the Abbreviated Injury Scale. Three body systems with the highest AIS scores are used to calculate the Injury Severity Score (ISS). These scores are squared and the results summed to produce the Injury Severity Score which ranges from 3-75. The higher the ISS the greater the injury.
|
|
Injury Severity Score, median
Elderly
|
14 Injury Severity Scale Score
n=29 Participants • Injury severity of each of 6 body systems is scored according the Abbreviated Injury Scale. Three body systems with the highest AIS scores are used to calculate the Injury Severity Score (ISS). These scores are squared and the results summed to produce the Injury Severity Score which ranges from 3-75. The higher the ISS the greater the injury.
|
13 Injury Severity Scale Score
n=30 Participants • Injury severity of each of 6 body systems is scored according the Abbreviated Injury Scale. Three body systems with the highest AIS scores are used to calculate the Injury Severity Score (ISS). These scores are squared and the results summed to produce the Injury Severity Score which ranges from 3-75. The higher the ISS the greater the injury.
|
13 Injury Severity Scale Score
n=59 Participants • Injury severity of each of 6 body systems is scored according the Abbreviated Injury Scale. Three body systems with the highest AIS scores are used to calculate the Injury Severity Score (ISS). These scores are squared and the results summed to produce the Injury Severity Score which ranges from 3-75. The higher the ISS the greater the injury.
|
|
Injury Severity Score greater than15
Adult
|
19 participants
n=46 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
26 participants
n=45 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
45 participants
n=91 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
|
Injury Severity Score greater than15
Elderly
|
14 participants
n=29 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
10 participants
n=30 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
24 participants
n=59 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
|
ICU Admission
Adult
|
25 participants
n=46 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
21 participants
n=45 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
46 participants
n=91 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
|
ICU Admission
Elderly
|
26 participants
n=29 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
25 participants
n=30 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
51 participants
n=59 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
|
Motor Vehicle Collision
Adult
|
20 participants
n=46 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
21 participants
n=45 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
41 participants
n=91 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
|
Motor Vehicle Collision
Elderly
|
11 participants
n=29 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
9 participants
n=30 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
20 participants
n=59 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
|
Fall
Adult
|
14 participants
n=46 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
11 participants
n=45 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
25 participants
n=91 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
|
Fall
Elderly
|
14 participants
n=29 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
16 participants
n=30 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
30 participants
n=59 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
|
Other Mechanism of Injury
Adult
|
12 participants
n=46 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
13 participants
n=45 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
25 participants
n=91 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
|
Other Mechanism of Injury
Elderly
|
4 participants
n=29 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
5 participants
n=30 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
9 participants
n=59 Participants • Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
|
PRIMARY outcome
Timeframe: 12-24 hours post infusionPopulation: Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
Visual Analog Numeric Pain scores are reported as a single numeric score between 0 and 10. The more severe the pain the higher the number with 10 representing the most severe pain imaginable.
Outcome measures
| Measure |
Placebo Infusion
n=75 Participants
Subjects in this arm received the institutional standard of care for rib fractures along with a placebo (NaCl) infusion.
|
Ketamine Infusion
n=75 Participants
Subjects in this arm will receive the institutional standard of care for rib fractures along with a ketamine infusion at a rate of 2.5 mcg/kg/min dosed based on ideal body weight.
|
|---|---|---|
|
Visual Analog Numeric Pain Score
Adult
|
6.1 score on a scale
Standard Deviation 2
|
5.7 score on a scale
Standard Deviation 2.1
|
|
Visual Analog Numeric Pain Score
Elderly
|
5.2 score on a scale
Standard Deviation 1.3
|
5.1 score on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: 24-48 hours post infusionPopulation: Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
Visual Analog Numeric Pain scores are reported as a single numeric score between 0 and 10. The more severe the pain the higher the number with 10 representing the most severe pain imaginable.
Outcome measures
| Measure |
Placebo Infusion
n=75 Participants
Subjects in this arm received the institutional standard of care for rib fractures along with a placebo (NaCl) infusion.
|
Ketamine Infusion
n=75 Participants
Subjects in this arm will receive the institutional standard of care for rib fractures along with a ketamine infusion at a rate of 2.5 mcg/kg/min dosed based on ideal body weight.
|
|---|---|---|
|
Visual Analog Numeric Pain Score
Adult
|
5.8 score on a scale
Standard Deviation 1.9
|
5.6 score on a scale
Standard Deviation 2
|
|
Visual Analog Numeric Pain Score
Elderly
|
4.4 score on a scale
Standard Deviation 1.6
|
5.1 score on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: 12-24 hours post infusionPopulation: Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
This is an analysis of the narcotic utilization during the study. Oral Morphine Equivalents is a means of standardizing narcotic utilization given a multitude of different medications are utilized. Medications are standardized to units (milligrams) or oral morphine for a standardized comparison.
Outcome measures
| Measure |
Placebo Infusion
n=75 Participants
Subjects in this arm received the institutional standard of care for rib fractures along with a placebo (NaCl) infusion.
|
Ketamine Infusion
n=75 Participants
Subjects in this arm will receive the institutional standard of care for rib fractures along with a ketamine infusion at a rate of 2.5 mcg/kg/min dosed based on ideal body weight.
|
|---|---|---|
|
Oral Morphine Equivalent (Narcotic Usage)
Adult
|
45.0 oral morphine equivalents
Interval 0.0 to 295.0
|
45 oral morphine equivalents
Interval 0.0 to 187.2
|
|
Oral Morphine Equivalent (Narcotic Usage)
Elderly
|
30 oral morphine equivalents
Interval 0.0 to 131.0
|
21.3 oral morphine equivalents
Interval 0.0 to 203.0
|
SECONDARY outcome
Timeframe: 24-48 hours post infusionPopulation: Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
This is an analysis of the narcotic utilization during the study. Oral Morphine Equivalents is a means of standardizing narcotic utilization given a multitude of different medications are utilized. Medications are standardized to units (milligrams) or oral morphine for a standardized comparison.
Outcome measures
| Measure |
Placebo Infusion
n=75 Participants
Subjects in this arm received the institutional standard of care for rib fractures along with a placebo (NaCl) infusion.
|
Ketamine Infusion
n=75 Participants
Subjects in this arm will receive the institutional standard of care for rib fractures along with a ketamine infusion at a rate of 2.5 mcg/kg/min dosed based on ideal body weight.
|
|---|---|---|
|
Oral Morphine Equivalent (Narcotic Usage)
Adult
|
67 oral morphine equivalents
Interval 0.0 to 1201.0
|
69.0 oral morphine equivalents
Interval 0.0 to 656.5
|
|
Oral Morphine Equivalent (Narcotic Usage)
Elderly
|
44 oral morphine equivalents
Interval 0.0 to 302.0
|
25 oral morphine equivalents
Interval 0.0 to 765.0
|
SECONDARY outcome
Timeframe: Total Index Hospitalization up to 365 daysPopulation: Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
Total hospital length of stay in days up to 365 days.
Outcome measures
| Measure |
Placebo Infusion
n=75 Participants
Subjects in this arm received the institutional standard of care for rib fractures along with a placebo (NaCl) infusion.
|
Ketamine Infusion
n=75 Participants
Subjects in this arm will receive the institutional standard of care for rib fractures along with a ketamine infusion at a rate of 2.5 mcg/kg/min dosed based on ideal body weight.
|
|---|---|---|
|
Length of Stay
Adult
|
4.0 days
Interval 1.0 to 33.0
|
5 days
Interval 1.0 to 20.0
|
|
Length of Stay
Elderly
|
6 days
Interval 2.0 to 109.0
|
5 days
Interval 2.0 to 50.0
|
SECONDARY outcome
Timeframe: Total Index Hospitalization up to 365 daysPopulation: Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
This is a measure of the Epidural Placement rates. Epidural placement was binary as in patient received or did not receive an epidural infusion catheter for supplemental pain management.
Outcome measures
| Measure |
Placebo Infusion
n=75 Participants
Subjects in this arm received the institutional standard of care for rib fractures along with a placebo (NaCl) infusion.
|
Ketamine Infusion
n=75 Participants
Subjects in this arm will receive the institutional standard of care for rib fractures along with a ketamine infusion at a rate of 2.5 mcg/kg/min dosed based on ideal body weight.
|
|---|---|---|
|
Regional Anesthesia Utilization
Adult
|
3 participants
|
7 participants
|
|
Regional Anesthesia Utilization
Elderly
|
6 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Total Index Hospitalization up to 365 daysPopulation: Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
Respiratory failure within this trial was defined by the need for unanticipated intubation and/or transfer to ICU for respiratory support.
Outcome measures
| Measure |
Placebo Infusion
n=75 Participants
Subjects in this arm received the institutional standard of care for rib fractures along with a placebo (NaCl) infusion.
|
Ketamine Infusion
n=75 Participants
Subjects in this arm will receive the institutional standard of care for rib fractures along with a ketamine infusion at a rate of 2.5 mcg/kg/min dosed based on ideal body weight.
|
|---|---|---|
|
Respiratory Failure
Adult
|
3 Participants
|
2 Participants
|
|
Respiratory Failure
Elderly
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Total Index Hospitalization up to 365 daysPopulation: Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
Hallucinations were documented and confirmed by the treating medical team.
Outcome measures
| Measure |
Placebo Infusion
n=75 Participants
Subjects in this arm received the institutional standard of care for rib fractures along with a placebo (NaCl) infusion.
|
Ketamine Infusion
n=75 Participants
Subjects in this arm will receive the institutional standard of care for rib fractures along with a ketamine infusion at a rate of 2.5 mcg/kg/min dosed based on ideal body weight.
|
|---|---|---|
|
Hallucination
Adult
|
1 Participants
|
0 Participants
|
|
Hallucination
Elderly
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Total Index Hospitalization up to 365 daysPopulation: A total of 45 participants were categorized as severely injured within the adult trial. A total of 24 participants were categorized as severely injured within the elderly trial.
This is an analysis of the narcotic utilization during the study. Oral Morphine Equivalents is a means of standardizing narcotic utilization given a multitude of different medications are utilized. Medications are standardized to units (milligrams) or oral morphine for a standardized comparison.
Outcome measures
| Measure |
Placebo Infusion
n=33 Participants
Subjects in this arm received the institutional standard of care for rib fractures along with a placebo (NaCl) infusion.
|
Ketamine Infusion
n=36 Participants
Subjects in this arm will receive the institutional standard of care for rib fractures along with a ketamine infusion at a rate of 2.5 mcg/kg/min dosed based on ideal body weight.
|
|---|---|---|
|
Oral Morphine Equivalent (Narcotic Usage) in Severely Injured
Elderly
|
86.8 oral morphine equivalents
Interval 0.0 to 376.0
|
67.5 oral morphine equivalents
Interval 0.0 to 988.0
|
|
Oral Morphine Equivalent (Narcotic Usage) in Severely Injured
Adult
|
170.5 oral morphine equivalents
Interval 0.0 to 1589.0
|
153.0 oral morphine equivalents
Interval 0.0 to 758.5
|
Adverse Events
Placebo Infusion
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Ketamine Infusion
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo Infusion
n=75 participants at risk
Subjects in this arm received the institutional standard of care for rib fractures along with a placebo (NaCl) infusion.
|
Ketamine Infusion
n=75 participants at risk
Subjects in this arm will receive the institutional standard of care for rib fractures along with a ketamine infusion at a rate of 2.5 mcg/kg/min dosed based on ideal body weight.
|
|---|---|---|
|
Psychiatric disorders
Delirium
|
4.0%
3/75 • Data was collected for the duration of all participants hospitalizations. At time of discharge adverse event recording was stopped as patients were monitored throughout only their index stay defined up to 365 days.
All adverse events were reported and reviewed by the IRB at our insitution.
|
1.3%
1/75 • Data was collected for the duration of all participants hospitalizations. At time of discharge adverse event recording was stopped as patients were monitored throughout only their index stay defined up to 365 days.
All adverse events were reported and reviewed by the IRB at our insitution.
|
|
Psychiatric disorders
Sedation
|
8.0%
6/75 • Data was collected for the duration of all participants hospitalizations. At time of discharge adverse event recording was stopped as patients were monitored throughout only their index stay defined up to 365 days.
All adverse events were reported and reviewed by the IRB at our insitution.
|
2.7%
2/75 • Data was collected for the duration of all participants hospitalizations. At time of discharge adverse event recording was stopped as patients were monitored throughout only their index stay defined up to 365 days.
All adverse events were reported and reviewed by the IRB at our insitution.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
4.0%
3/75 • Data was collected for the duration of all participants hospitalizations. At time of discharge adverse event recording was stopped as patients were monitored throughout only their index stay defined up to 365 days.
All adverse events were reported and reviewed by the IRB at our insitution.
|
2.7%
2/75 • Data was collected for the duration of all participants hospitalizations. At time of discharge adverse event recording was stopped as patients were monitored throughout only their index stay defined up to 365 days.
All adverse events were reported and reviewed by the IRB at our insitution.
|
|
Psychiatric disorders
Hallucinations
|
4.0%
3/75 • Data was collected for the duration of all participants hospitalizations. At time of discharge adverse event recording was stopped as patients were monitored throughout only their index stay defined up to 365 days.
All adverse events were reported and reviewed by the IRB at our insitution.
|
2.7%
2/75 • Data was collected for the duration of all participants hospitalizations. At time of discharge adverse event recording was stopped as patients were monitored throughout only their index stay defined up to 365 days.
All adverse events were reported and reviewed by the IRB at our insitution.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place