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

• Sponsor: Medical College of Wisconsin (Other)
• Overall Status: Completed
• CT.gov ID: NCT02432456
• Collaborator: (none)
• Enrollment: 153
• Location: 1
• Arms: 2
• Duration (Months): 35
• Patients Per Site Per Month: 4.4

Study Details

Study Description

Brief Summary

This study will evaluate the effectiveness of ketamine infusions in the management of acute pain resulting from broken ribs suffered following a blunt trauma. Half of patients will receive the institutional standard of care and a placebo infusion (no active medication). The other half of patients will receive the institutional standard of care and a ketamine infusion. All subjects and staff will be blinded as to whether they are receiving placebo or ketamine.

Condition or Disease	Intervention/Treatment	Phase
Wounds and Injuries; Rib Fractures	Drug: Ketamine; Drug: Placebo; Procedure: Intercostal Nerve Block; Drug: Acetaminophen; Drug: Ibuprofen; Drug: Pantoprazole; Drug: Methocarbamol; Drug: Opioid	Phase 4

Detailed Description

A prospective randomized, double blinded trial of ketamine use in adult and elderly blunt trauma patients with associated rib fractures admitted to the trauma service will be conducted. Examples of blunt mechanisms include assault, falls, motor vehicle collisions, motorcycle crashes, motor vehicle pedestrian collisions, crush injuries, and bicycle accidents. The experimental arm of the trial will receive ketamine infusion therapy while the control arm receives saline placebo infusions at an equivalent rate. All patients will be managed with adjunct therapy including opiates in accordance with the institutional thoracic trauma protocols. Two separate trials based on patient age are included in this study. Elderly rib fracture patients are certainly of interest but will be evaluated as a distinct entity given the discrete differences in the complications of rib fractures and the goals of therapy.

All blunt trauma patients with associated rib fractures will be screened. All patients will be enrolled into the institutional standard thoracic trauma pathway. All individuals will undergo Intercostal Nerve Block (ICNB) in the Emergency Department or on admission to the Intensive Care Unit. In addition to scheduled medications per institutional thoracic trauma protocols, all patients will receive adjunct opiate therapy. Patients will be screened by the clinical and pharmacy staff following the diagnosis of rib fractures for eligibility. Patients enrolled into the trial will be randomized into either the experimental or control arm of the trial. The Investigational Drug Services (IDS) department will randomize all enrollees and handle administration of all trial drugs. The infusate will be mixed by the IDS department and all bags will be labeled "Ketamine / Placebo." The IDS department will have unique bag identifiers, which will allow them to identify which bags have active ketamine and which are placebo in case of emergency.

Patients will be randomized in a 1:1 fashion for experimental and control arms. Those enrolled in the experimental arm will receive early ketamine infusion therapy at a fixed infusion rate. For those enrolled in the adult trial the infusion rate will be 2.5 mcg/kg/min while those in the elderly trial will receive infusions at 2.0 mcg/kg/min. All ketamine infusions will be calculated based on ideal body weight (IBW), unless actual body weight is less than ideal. IBW will be calculated for males as 50kg + 2.3*(number of inches above 5 feet) and for women as 45.5kg + 2.3*(number of inches over 5 feet). Patients randomized to the control arm will receive placebo saline solution at an equivalent rate. Time zero will be defined as the time at which the "ketamine / placebo" infusion is begun. For inclusion in the trial, initiation of ketamine / placebo infusions must take place within 6 hours of presentation to Froedtert Memorial Lutheran Hospital (FMLH). Ketamine infusion therapy will be continued for 48 hours. At 6-8 hours post-ICNB all subjects will be assessed for need for repeat ICNB. Need for repeat ICNB will be defined by a thoracic specific numeric pain score greater than seven. Between eight and ten hours post-ketamine infusion initiation, subjects who have thoracic specific pain scores above seven will be evaluated for epidural placement by the Regional Anesthesia and Acute Pain Service.

A subject will be allowed to remove himself/herself from the trial or be un-blinded should he/she, pharmacy, anesthesia, and/or surgical staff deem it medically necessary. Medical necessity would be determined by inability to treat the patient appropriately without knowledge of trial assignment; otherwise the assumption of treating staff will be all patients have received ketamine. All adverse events will be recorded and if necessary subjects will be un-blinded in the event of a serious adverse event. The trauma and anesthesia teams along with the inpatient clinical pharmacists will monitor all trial patients for any adverse event trends. Patients will be followed through the time of discharge.

Study Design

• Study Type: Interventional
• Actual Enrollment: 153 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Ketamine Infusion Therapy for the Management of Acute Pain in Adult Rib Fracture Patients
• Study Start Date: Sep 1, 2015
• Actual Primary Completion Date: Aug 1, 2018
• Actual Study Completion Date: Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Infusion Subjects in this arm will receive the institutional standard of care for rib fractures along with a placebo (NaCl) infusion. All patients will undergo Intercostal Nerve Blockade with administration of scheduled medications including acetaminophen, ibuprofen, pantoprazole, and methocarbamol. All subjects will receive adjunct opioids.	Drug: Placebo; Individuals enrolled into the control arm of the trial will receive a normal saline placebo infusion at a rate equivalent to the dosage of ketamine in the experimental arm.; Other Names: NaCl Placebo Solution ; Procedure: Intercostal Nerve Block; All individuals enrolled into the trial will undergo an Intercostal Nerve Blockade as a part of the institutional standard of care for rib fractures. This procedure will be performed according to current standard protocols in the Emergency Department or on admission.; Other Names: Rib Block ; Drug: Acetaminophen; All patients admitted to the hospital will be placed on scheduled acetaminophen 1000mg PO q 6 hours unless signs of liver disease/impairment or creatinine clearance < 35ml/min at which point dosage would be reduced to 650mg q 8 hours. Individuals unable to take oral medications would be placed on intravenous acetaminophen.; Other Names: Tylenol ; Drug: Ibuprofen; All patients will be placed on scheduled Ibuprofen or an equivalent NSAID at dosage of 600mg every 6 hours. Patients must have a Glomerular Filtration Rate > 60 ml/min with no contraindications to NSAID therapy (e.g. Aspirin use, allergy/sensitivity, concurrent ACE inhibitor use, other nephrotoxins, etc); Other Names: Advil, Motrin ; Drug: Pantoprazole; All individuals on scheduled Non-Steroidal Anti-Inflammatory Drug (NSAID) therapy will receive scheduled pantoprazole at 40mg daily. Individuals unable to take medications orally will be placed on intravenous therapy. Individuals with previous reaction or intolerance to pantoprazole will be placed on an equivalent proton pump inhibitor.; Other Names: Protonix ; Drug: Methocarbamol; All individuals enrolled in the trial will be placed on scheduled methocarbamol 500 mg orally every 6 hours while admitted. Individuals with previous intolerance to methocarbamol will be placed on a pharmacy directed equivalent.; Other Names: Robaxin ; Drug: Opioid; All individuals will receive as needed opiate therapy as an adjunct to the scheduled medications and "ketamine/placebo" solution. Choice in opiate therapy will be at the discretion of the attending trauma faculty. Dosage and adjustments will be in accordance with the institutional policy on appropriate opiate dosage adjustment.; Other Names: opiate, narcotic
Experimental: Ketamine Infusion Subjects in this arm will receive the institutional standard of care for rib fractures along with a ketamine infusion. All patients will undergo Intercostal Nerve Blockade with administration of scheduled medications including acetaminophen, ibuprofen, pantoprazole, and methocarbamol. All subjects will receive adjunct opioids.	Drug: Ketamine; All individuals randomized to the experimental arm of the trial will receive early ketamine therapy (within 6 hours of admission) at a rate of 0.15 mg/kg/hr dosed based on ideal body weight. Individuals in the control arm will receive our standard of care for thoracic trauma patients, however, they will receive an additional placebo infusion of normal saline.; Procedure: Intercostal Nerve Block; All individuals enrolled into the trial will undergo an Intercostal Nerve Blockade as a part of the institutional standard of care for rib fractures. This procedure will be performed according to current standard protocols in the Emergency Department or on admission.; Other Names: Rib Block ; Drug: Acetaminophen; All patients admitted to the hospital will be placed on scheduled acetaminophen 1000mg PO q 6 hours unless signs of liver disease/impairment or creatinine clearance < 35ml/min at which point dosage would be reduced to 650mg q 8 hours. Individuals unable to take oral medications would be placed on intravenous acetaminophen.; Other Names: Tylenol ; Drug: Ibuprofen; All patients will be placed on scheduled Ibuprofen or an equivalent NSAID at dosage of 600mg every 6 hours. Patients must have a Glomerular Filtration Rate > 60 ml/min with no contraindications to NSAID therapy (e.g. Aspirin use, allergy/sensitivity, concurrent ACE inhibitor use, other nephrotoxins, etc); Other Names: Advil, Motrin ; Drug: Pantoprazole; All individuals on scheduled Non-Steroidal Anti-Inflammatory Drug (NSAID) therapy will receive scheduled pantoprazole at 40mg daily. Individuals unable to take medications orally will be placed on intravenous therapy. Individuals with previous reaction or intolerance to pantoprazole will be placed on an equivalent proton pump inhibitor.; Other Names: Protonix ; Drug: Methocarbamol; All individuals enrolled in the trial will be placed on scheduled methocarbamol 500 mg orally every 6 hours while admitted. Individuals with previous intolerance to methocarbamol will be placed on a pharmacy directed equivalent.; Other Names: Robaxin ; Drug: Opioid; All individuals will receive as needed opiate therapy as an adjunct to the scheduled medications and "ketamine/placebo" solution. Choice in opiate therapy will be at the discretion of the attending trauma faculty. Dosage and adjustments will be in accordance with the institutional policy on appropriate opiate dosage adjustment.; Other Names: opiate, narcotic

Outcome Measures

Primary Outcome Measures

1. Visual Analog Numeric Pain Score [12-24 hours post infusion]

   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.

Secondary Outcome Measures

1. Visual Analog Numeric Pain Score [24-48 hours post infusion]

   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.

2. Oral Morphine Equivalent (Narcotic Usage) [12-24 hours post infusion]

   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.

3. Oral Morphine Equivalent (Narcotic Usage) [24-48 hours post infusion]

   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.

4. Length of Stay [Total Index Hospitalization up to 365 days]

   Total hospital length of stay in days up to 365 days.

5. Regional Anesthesia Utilization [Total Index Hospitalization up to 365 days]

   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.

6. Respiratory Failure [Total Index Hospitalization up to 365 days]

   Respiratory failure within this trial was defined by the need for unanticipated intubation and/or transfer to ICU for respiratory support.

7. Hallucination [Total Index Hospitalization up to 365 days]

   Hallucinations were documented and confirmed by the treating medical team.

8. Oral Morphine Equivalent (Narcotic Usage) in Severely Injured [Total Index Hospitalization up to 365 days]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. age greater than 18 years

2. rib fractures following recent trauma with admission to Froedtert Memorial Lutheran Hospital

Exclusion Criteria:

1. history of adverse reaction / intolerance to ketamine therapy

2. elevated intracranial pressure

3. ischemic heart disease defined as active acute coronary syndrome

4. severe, poorly controlled hypertension (Systolic Blood Pressure > 200 mmHg or Diastolic Blood Pressure > 100 mmHg)

5. current opiate agonist/antagonist therapy

6. concurrent use of monoamine oxidase inhibitors (MAOIs)

7. chronic pain or opioid tolerance defined as > 3 weeks of >30mg oral morphine equivalents per day

8. current substance abuse with opiates (prescription and/or heroin) or ketamine

9. Glasgow Coma Scale <13

10. Intubation on arrival or need for urgent intubation on arrival

11. inability to delineate pain and/or appropriately communicate with staff

12. history of psychosis

13. three or more psychotropic medications

14. active delirium

15. glaucoma

16. pregnancy

17. prisoners

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Froedtert Memorial Lutheran Hospital	Milwaukee	Wisconsin	United States	53226

Sponsors and Collaborators

• Medical College of Wisconsin

Investigators

• Principal Investigator: Thomas W Carver, MD, Medical College of Wisconsin

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 1, 2018

More Information

Publications

None provided.

• Responsible Party: Nathan Kugler, Lead Research Resident, Medical College of Wisconsin
• ClinicalTrials.gov Identifier: NCT02432456
• Other Study ID Numbers: PRO00024679
• First Posted: May 4, 2015
• Last Update Posted: Feb 5, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Acute Pain; Fractures, Bone; Rib Fractures; Wounds and Injuries; Acetaminophen; Ibuprofen; Ketamine; Narcotics; Methocarbamol; Pantoprazole

Study Results

Participant Flow

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 Detail	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
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

Baseline Characteristics

Arm/Group Title	Placebo Infusion	Ketamine Infusion	Total
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 Participants	75	75	150
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	46 61.3%	45 60%	91 60.7%
>=65 years	29 38.7%	30 40%	59 39.3%
Sex: Female, Male (Count of Participants)
Female	21 28%	26 34.7%	47 31.3%
Male	54 72%	49 65.3%	103 68.7%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	75 100%	75 100%	150 100%
BMI (kg/m^2) [Median (Inter-Quartile Range) ]
Adult BMI	28.5	29	29
Elderly BMI	26.8	29.2	27.7
Number of Rib Fractures (Rib Fractures) [Mean (Standard Deviation) ]
Adult	6.4 (3.3)	6.4 (3.2)	6.4 (3.2)
Elderly	6.5 (3.4)	6.1 (2.6)	6.3 (3.0)
Flail Chest (participants) [Number]
Adult	11 14.7%	15 20%	26 17.3%
Elderly	9 12%	4 5.3%	13 8.7%
Injury Severity Score, median (Injury Severity Scale Score) [Median (Inter-Quartile Range) ]
Adult	13	17	14
Elderly	14	13	13
Injury Severity Score greater than15 (participants) [Number]
Adult	19 25.3%	26 34.7%	45 30%
Elderly	14 18.7%	10 13.3%	24 16%
ICU Admission (participants) [Number]
Adult	25 33.3%	21 28%	46 30.7%
Elderly	26 34.7%	25 33.3%	51 34%
Motor Vehicle Collision (participants) [Number]
Adult	20 26.7%	21 28%	41 27.3%
Elderly	11 14.7%	9 12%	20 13.3%
Fall (participants) [Number]
Adult	14 18.7%	11 14.7%	25 16.7%
Elderly	14 18.7%	16 21.3%	30 20%
Other Mechanism of Injury (participants) [Number]
Adult	12 16%	13 17.3%	25 16.7%
Elderly	4 5.3%	5 6.7%	9 6%

Outcome Measures

1. Primary Outcome

Title	Visual Analog Numeric Pain Score
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

Outcome Measure Data

Analysis Population Description

Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.

Arm/Group Title	Placebo Infusion	Ketamine Infusion
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.
Measure Participants	75	75
Adult	6.1 (2)	5.7 (2.1)
Elderly	5.2 (1.3)	5.1 (1.9)

2. Secondary Outcome

Title	Visual Analog Numeric Pain Score
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

Outcome Measure Data

Analysis Population Description

Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.

Arm/Group Title	Placebo Infusion	Ketamine Infusion
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.
Measure Participants	75	75
Adult	5.8 (1.9)	5.6 (2)
Elderly	4.4 (1.6)	5.1 (1.7)

3. Secondary Outcome

Title	Oral Morphine Equivalent (Narcotic Usage)
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

Outcome Measure Data

Analysis Population Description

Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.

Arm/Group Title	Placebo Infusion	Ketamine Infusion
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.
Measure Participants	75	75
Adult	45.0	45
Elderly	30	21.3

4. Secondary Outcome

Title	Oral Morphine Equivalent (Narcotic Usage)
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

Outcome Measure Data

Analysis Population Description

Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.

Arm/Group Title	Placebo Infusion	Ketamine Infusion
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.
Measure Participants	75	75
Adult	67	69.0
Elderly	44	25

5. Secondary Outcome

Title	Length of Stay
Description	Total hospital length of stay in days up to 365 days.
Time Frame	Total Index Hospitalization up to 365 days

Outcome Measure Data

Analysis Population Description

Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.

Arm/Group Title	Placebo Infusion	Ketamine Infusion
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.
Measure Participants	75	75
Adult	4.0	5
Elderly	6	5

6. Secondary Outcome

Title	Regional Anesthesia Utilization
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

Outcome Measure Data

Analysis Population Description

Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.

Arm/Group Title	Placebo Infusion	Ketamine Infusion
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.
Measure Participants	75	75
Adult	3 4%	7 9.3%
Elderly	6 8%	4 5.3%

7. Secondary Outcome

Title	Respiratory Failure
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

Outcome Measure Data

Analysis Population Description

Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.

Arm/Group Title	Placebo Infusion	Ketamine Infusion
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.
Measure Participants	75	75
Adult	3 4%	2 2.7%
Elderly	0 0%	0 0%

8. Secondary Outcome

Title	Hallucination
Description	Hallucinations were documented and confirmed by the treating medical team.
Time Frame	Total Index Hospitalization up to 365 days

Outcome Measure Data

Analysis Population Description

Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.

Arm/Group Title	Placebo Infusion	Ketamine Infusion
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.
Measure Participants	75	75
Adult	1 1.3%	0 0%
Elderly	2 2.7%	2 2.7%

9. Secondary Outcome

Title	Oral Morphine Equivalent (Narcotic Usage) in Severely Injured
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

Outcome Measure Data

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
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.
Measure Participants	33	36
Adult	170.5	153.0
Elderly	86.8	67.5

Adverse Events

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
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/75 (0%)		0/75 (0%)
Serious Adverse Events
	Placebo Infusion		Ketamine Infusion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/75 (0%)		0/75 (0%)
Other (Not Including Serious) Adverse Events
	Placebo Infusion		Ketamine Infusion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	15/75 (20%)		7/75 (9.3%)
Psychiatric disorders
Delirium	3/75 (4%)		1/75 (1.3%)
Sedation	6/75 (8%)		2/75 (2.7%)
Hallucinations	3/75 (4%)		2/75 (2.7%)
Respiratory, thoracic and mediastinal disorders
Respiratory Failure	3/75 (4%)		2/75 (2.7%)

Limitations/Caveats

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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.