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Ketamine Infusion Therapy for the Management of Acute Pain in Adult Rib Fracture Patients

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ClinicalTrials.gov Identifier: NCT02432456
Recruitment Status : Completed
First Posted : May 4, 2015
Results First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Nathan Kugler, Medical College of Wisconsin

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Wounds and Injuries
Rib Fractures
Interventions Drug: Ketamine
Drug: Placebo
Procedure: Intercostal Nerve Block
Drug: Acetaminophen
Drug: Ibuprofen
Drug: Pantoprazole
Drug: Methocarbamol
Drug: Opioid
Enrollment 153
Recruitment Details

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.

Pre-assignment Details 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 Three subjects (two from elderly and one from adult) were randomized but withdrawn prior to collecting any data or initiation of the infusions.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.
Arm/Group Title Placebo Infusion Ketamine Infusion
Hide Arm/Group Description Subjects in this arm received the institutional standard of care for rib fractures along with a placebo (NaCl) 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.
Period Title: Overall Study
Started 75 75
Completed 75 75
Not Completed 0 0
Arm/Group Title Placebo Infusion Ketamine Infusion Total
Hide Arm/Group Description Subjects in this arm received the institutional standard of care for rib fractures along with a placebo (NaCl) 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. Total of all reporting groups
Overall Number of Baseline Participants 75 75 150
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 150 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
46
  61.3%
45
  60.0%
91
  60.7%
>=65 years
29
  38.7%
30
  40.0%
59
  39.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 150 participants
Female
21
  28.0%
26
  34.7%
47
  31.3%
Male
54
  72.0%
49
  65.3%
103
  68.7%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 75 participants 75 participants 150 participants
75 75 150
BMI   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Kg/m^2
Adult BMI Number Analyzed 46 participants 45 participants 91 participants
28.5
(18.7 to 50)
29
(18.3 to 51.7)
29
(18.3 to 51.7)
Elderly BMI Number Analyzed 29 participants 30 participants 59 participants
26.8
(20.6 to 39.7)
29.2
(22.5 to 38)
27.7
(20.6 to 39.7)
[1]
Measure Analysis Population Description: Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
Number of Rib Fractures   [1] 
Mean (Standard Deviation)
Unit of measure:  Rib Fractures
Adult Number Analyzed 46 participants 45 participants 91 participants
6.4  (3.3) 6.4  (3.2) 6.4  (3.2)
Elderly Number Analyzed 29 participants 30 participants 59 participants
6.5  (3.4) 6.1  (2.6) 6.3  (3.0)
[1]
Measure Analysis Population Description: Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
Flail Chest   [1] 
Measure Type: Number
Unit of measure:  Participants
Adult Number Analyzed 46 participants 45 participants 91 participants
11 15 26
Elderly Number Analyzed 29 participants 30 participants 59 participants
9 4 13
[1]
Measure Analysis Population Description: Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
Injury Severity Score, median   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Injury Severity Scale Score
Adult Number Analyzed 46 participants 45 participants 91 participants
13
(9 to 38)
17
(9 to 34)
14
(9 to 38)
Elderly Number Analyzed 29 participants 30 participants 59 participants
14
(9 to 48)
13
(4 to 41)
13
(4 to 48)
[1]
Measure Analysis Population Description: 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   [1] 
Measure Type: Number
Unit of measure:  Participants
Adult Number Analyzed 46 participants 45 participants 91 participants
19 26 45
Elderly Number Analyzed 29 participants 30 participants 59 participants
14 10 24
[1]
Measure Analysis Population Description: Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
ICU Admission   [1] 
Measure Type: Number
Unit of measure:  Participants
Adult Number Analyzed 46 participants 45 participants 91 participants
25 21 46
Elderly Number Analyzed 29 participants 30 participants 59 participants
26 25 51
[1]
Measure Analysis Population Description: Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
Motor Vehicle Collision   [1] 
Measure Type: Number
Unit of measure:  Participants
Adult Number Analyzed 46 participants 45 participants 91 participants
20 21 41
Elderly Number Analyzed 29 participants 30 participants 59 participants
11 9 20
[1]
Measure Analysis Population Description: Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
Fall   [1] 
Measure Type: Number
Unit of measure:  Participants
Adult Number Analyzed 46 participants 45 participants 91 participants
14 11 25
Elderly Number Analyzed 29 participants 30 participants 59 participants
14 16 30
[1]
Measure Analysis Population Description: Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
Other Mechanism of Injury   [1] 
Measure Type: Number
Unit of measure:  Participants
Adult Number Analyzed 46 participants 45 participants 91 participants
12 13 25
Elderly Number Analyzed 29 participants 30 participants 59 participants
4 5 9
[1]
Measure Analysis Population Description: Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
1.Primary Outcome
Title Visual Analog Numeric Pain Score
Hide Description 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.
Time Frame 12-24 hours post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
Arm/Group Title Placebo Infusion Ketamine Infusion
Hide Arm/Group Description:
Subjects in this arm received the institutional standard of care for rib fractures along with a placebo (NaCl) 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 Number of Participants Analyzed 75 75
Mean (Standard Deviation)
Unit of Measure: score on a scale
Adult Number Analyzed 46 participants 45 participants
6.1  (2) 5.7  (2.1)
Elderly Number Analyzed 29 participants 30 participants
5.2  (1.3) 5.1  (1.9)
2.Secondary Outcome
Title Visual Analog Numeric Pain Score
Hide Description 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.
Time Frame 24-48 hours post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
Arm/Group Title Placebo Infusion Ketamine Infusion
Hide Arm/Group Description:
Subjects in this arm received the institutional standard of care for rib fractures along with a placebo (NaCl) 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 Number of Participants Analyzed 75 75
Mean (Standard Deviation)
Unit of Measure: score on a scale
Adult Number Analyzed 46 participants 45 participants
5.8  (1.9) 5.6  (2)
Elderly Number Analyzed 29 participants 30 participants
4.4  (1.6) 5.1  (1.7)
3.Secondary Outcome
Title Oral Morphine Equivalent (Narcotic Usage)
Hide Description 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.
Time Frame 12-24 hours post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
Arm/Group Title Placebo Infusion Ketamine Infusion
Hide Arm/Group Description:
Subjects in this arm received the institutional standard of care for rib fractures along with a placebo (NaCl) 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 Number of Participants Analyzed 75 75
Median (Full Range)
Unit of Measure: oral morphine equivalents
Adult Number Analyzed 46 participants 45 participants
45.0
(0 to 295)
45
(0 to 187.2)
Elderly Number Analyzed 29 participants 30 participants
30
(0 to 131)
21.3
(0 to 203)
4.Secondary Outcome
Title Oral Morphine Equivalent (Narcotic Usage)
Hide Description 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.
Time Frame 24-48 hours post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
Arm/Group Title Placebo Infusion Ketamine Infusion
Hide Arm/Group Description:
Subjects in this arm received the institutional standard of care for rib fractures along with a placebo (NaCl) 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 Number of Participants Analyzed 75 75
Median (Full Range)
Unit of Measure: oral morphine equivalents
Adult Number Analyzed 46 participants 45 participants
67
(0 to 1201.0)
69.0
(0 to 656.5)
Elderly Number Analyzed 29 participants 30 participants
44
(0 to 302)
25
(0 to 765)
5.Secondary Outcome
Title Length of Stay
Hide Description Total hospital length of stay in days up to 365 days.
Time Frame Total Index Hospitalization up to 365 days
Hide Outcome Measure Data
Hide Analysis Population Description
Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
Arm/Group Title Placebo Infusion Ketamine Infusion
Hide Arm/Group Description:
Subjects in this arm received the institutional standard of care for rib fractures along with a placebo (NaCl) 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 Number of Participants Analyzed 75 75
Median (Inter-Quartile Range)
Unit of Measure: days
Adult Number Analyzed 46 participants 45 participants
4.0
(1 to 33)
5
(1 to 20)
Elderly Number Analyzed 29 participants 30 participants
6
(2 to 109)
5
(2 to 50)
6.Secondary Outcome
Title Regional Anesthesia Utilization
Hide Description 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.
Time Frame Total Index Hospitalization up to 365 days
Hide Outcome Measure Data
Hide Analysis Population Description
Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
Arm/Group Title Placebo Infusion Ketamine Infusion
Hide Arm/Group Description:
Subjects in this arm received the institutional standard of care for rib fractures along with a placebo (NaCl) 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 Number of Participants Analyzed 75 75
Measure Type: Number
Unit of Measure: participants
Adult Number Analyzed 46 participants 45 participants
3 7
Elderly Number Analyzed 29 participants 30 participants
6 4
7.Secondary Outcome
Title Respiratory Failure
Hide Description Respiratory failure within this trial was defined by the need for unanticipated intubation and/or transfer to ICU for respiratory support.
Time Frame Total Index Hospitalization up to 365 days
Hide Outcome Measure Data
Hide Analysis Population Description
Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
Arm/Group Title Placebo Infusion Ketamine Infusion
Hide Arm/Group Description:
Subjects in this arm received the institutional standard of care for rib fractures along with a placebo (NaCl) 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 Number of Participants Analyzed 75 75
Measure Type: Count of Participants
Unit of Measure: Participants
Adult Number Analyzed 46 participants 45 participants
3
   6.5%
2
   4.4%
Elderly Number Analyzed 29 participants 31 participants
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title Hallucination
Hide Description Hallucinations were documented and confirmed by the treating medical team.
Time Frame Total Index Hospitalization up to 365 days
Hide Outcome Measure Data
Hide Analysis Population Description
Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.
Arm/Group Title Placebo Infusion Ketamine Infusion
Hide Arm/Group Description:
Subjects in this arm received the institutional standard of care for rib fractures along with a placebo (NaCl) 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 Number of Participants Analyzed 75 75
Measure Type: Count of Participants
Unit of Measure: Participants
Adult Number Analyzed 46 participants 45 participants
1
   2.2%
0
   0.0%
Elderly Number Analyzed 29 participants 30 participants
2
   6.9%
2
   6.7%
9.Secondary Outcome
Title Oral Morphine Equivalent (Narcotic Usage) in Severely Injured
Hide Description 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.
Time Frame Total Index Hospitalization up to 365 days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Infusion Ketamine Infusion
Hide Arm/Group Description:
Subjects in this arm received the institutional standard of care for rib fractures along with a placebo (NaCl) 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 Number of Participants Analyzed 33 36
Median (Full Range)
Unit of Measure: oral morphine equivalents
Adult Number Analyzed 19 participants 26 participants
170.5
(0 to 1589.0)
153.0
(0 to 758.5)
Elderly Number Analyzed 14 participants 10 participants
86.8
(0 to 376)
67.5
(0 to 988)
Time Frame 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.
Adverse Event Reporting Description All adverse events were reported and reviewed by the IRB at our insitution.
 
Arm/Group Title Placebo Infusion Ketamine Infusion
Hide Arm/Group Description Subjects in this arm received the institutional standard of care for rib fractures along with a placebo (NaCl) 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.
All-Cause Mortality
Placebo Infusion Ketamine Infusion
Affected / at Risk (%) Affected / at Risk (%)
Total   0/75 (0.00%)   0/75 (0.00%) 
Hide Serious Adverse Events
Placebo Infusion Ketamine Infusion
Affected / at Risk (%) Affected / at Risk (%)
Total   0/75 (0.00%)   0/75 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Infusion Ketamine Infusion
Affected / at Risk (%) Affected / at Risk (%)
Total   15/75 (20.00%)   7/75 (9.33%) 
Psychiatric disorders     
Delirium  [1]  3/75 (4.00%)  1/75 (1.33%) 
Sedation  [2]  6/75 (8.00%)  2/75 (2.67%) 
Hallucinations   3/75 (4.00%)  2/75 (2.67%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory Failure  [3]  3/75 (4.00%)  2/75 (2.67%) 
Indicates events were collected by systematic assessment
[1]
Delirium as outlined by positive CAM testing
[2]
Concern on nursing that patient was sedated as result of over medication
[3]
Need for intubation
NPS presents challenges as pain is subjective and difficult to assess. Treating providers were allowed any medications within the multimodal rib fracture pain protocol leading to non-standardized pain regimens based on providers.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Thomas Carver
Organization: Medical College of Wisconsin
Phone: 414-955-1733
EMail: tcarver@mcw.edu
Layout table for additonal information
Responsible Party: Nathan Kugler, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT02432456    
Other Study ID Numbers: PRO00024679
First Submitted: April 20, 2015
First Posted: May 4, 2015
Results First Submitted: December 15, 2019
Results First Posted: February 5, 2020
Last Update Posted: February 5, 2020