Ketamine for Acute Pain Management After Trauma

Study Overview
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Brief Summary
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The purpose of this study is to compare the effectiveness of Ketamine drip along with usual care and usual care alone on trauma patients and to longitudinally quantify the pain experience of patients during hospitalization.

Official Title
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Ketamine for Acute Pain After Trauma: KAPT Trial

Conditions
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Trauma Injury, Pain, Opioid Use

Intervention / Treatment
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* Drug: Ketamine plus usual care
* Drug: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult trauma patients Admission to Shock Trauma ICU (STICU) or Surgical Intermediate Unit (SIMU) Randomization within 6 hours of arrival Exclusion Criteria: Patient not expected to survive Contraindications to ketamine Allergy, Poorly controlled hypertension, Cardiac arrhythmia disorders (including atrial fibrillation), congestive heart failure, unstable coronary artery disease or recent myocardial infarction( MI)(within 6 months), cirrhosis, seizure disorder, and for those patients with unknown medical history - median sternotomy scar, mechanism of injury is fall from standing, 65 years of age or older, any arrhythmia on EKD) pregnancy in police custody history of dementia or movement disorder (i.e. Parkinson's)

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine plus Usual care<br> | Drug: Ketamine plus usual care<br>* Bolus of .35 mg/kg Infusion start @ 0.15 mg/kg/hr; titrate range is 0.1 - 0.25 mg/kg/hr for 24 to 48 hours after admission and each subsequent major surgery plus multi-modal pain therapy considered as standard of care. Standard of care medications include Acetaminophen 1000 mg po q6 hours, Naproxen 500 mg po q12 hours, Gabapentin 300 mg po q8 hours and Lidocaine patch q 12 hours.<br>|
| Active Comparator: Usual care<br> | Drug: Usual Care<br>* Standard of care medications include Acetaminophen 1000 mg po q6 hours, Naproxen 500 mg po q12 hours, Gabapentin 300 mg po q8 hours and Lidocaine patch q 12 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Daily Opioid Use as Measured by the Morphine Milligram Equivalents (MME) Per Day |  | In-hospital days (up to 6 weeks post hospital admission) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain as Assessed by Score on the Numeric Rating Scale (NRS) | The NRS ranges from 0 (no pain) to 10 (worst pain), with a higher score indicating a worse outcome. This scale is used in verbal participants. | Hospital discharge (up to 6 weeks post hospital admission) | 
| Number of Patients That Showed Signs of Delirium During In-hospital Stay | Incidence of delirium during in-hospital stay | Hospital discharge (up to 6 weeks post hospital admission) | 
| Number of Patients That Required Unplanned Intubation During In-hospital Stay | incidence of need for unplanned intubation during in-hospital stay | Hospital discharge (up to 6 weeks post hospital admission) | 
| Number of Patients Who Required Unplanned Admission to Intensive Care Unit During In-hospital Stay | Incidence of need for unplanned admission to an ICU | Hospital discharge (up to 6 weeks post hospital admission) | 
| Initiation of Ketamine Drip | Time from admission to time Ketamine drip started | Hospital discharge (up to 6 weeks post hospital admission) | 
| Duration of Ketamine Drip | Length of time Ketamine drip was infused | Hospital discharge (up to 6 weeks post hospital admission) | 
| Number of Patients Requesting to Discontinue Ketamine | Number of patients requesting to stop Ketamine for any complaint | Hospital discharge (up to 6 weeks post hospital admission) | 
| Use of Other Pain Control Adjuncts Including Regional Anesthesia and Lidocaine Patch | Incidence of use of additional pain control adjuncts such as regional anesthesia and lidocaine patch during hospitalization | Hospital discharge (up to 6 weeks post hospital admission) | 
| Ventilator Free Days | Number of inpatient hospital days patients did not require mechanical ventilation | Hospital discharge (up to 6 weeks post hospital admission) | 
| ICU Free Days | Number of inpatient hospital days patients did not require ICU level of care | Hospital discharge (up to 6 weeks post hospital admission) | 
| Hospital Free Days | Number of days patients were not in the hospital during the first 30 days after admission | 30 days post admission | 
| Number of Patients Discharged From the Hospital With an Opioid Prescription | Number of patients discharged from the hospital with an opioid prescription | Hospital discharge (up to 6 weeks post hospital admission) | 
| Number of Patients Who Reported Continued Pain Continued Post-traumatic Pain at 6 Months Post Admission | Number of patients who reported continued pain at 6 months following trauma injury | 6 months post admission | 
| Number of Patients Who Continue to Use Opioids at 6 Months Post Admission | Number of patients who continue to use opioids | 6 months post admission | 
| Post Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire | The PC-PTSD-5 questionnaire asks the below 5 questions, and data are reported categorically as the number of participants who responded yes to each of the 5 questions. An answer of yes is indicative of a PTSD symptom, which is a worse outcome. In the past month, have you had nightmares about the events or thought about the events when you did not want to? In the past month, have you tried hard not to think about the events or went out of your way to avoid situations that reminded you of the events? In the past month, have you been constantly on guard, watchful, or easily startled? In the past month, have you felt numb or detached from people, activities, or your surroundings? In the past month, have you felt guilty or unable to stop blaming yourself or others for the events or any problems the events may have caused? | 6 months post admission | 
| Risk of Future Opioid Abuse as Assessed by the Opioid Risk Tool (ORT) | Total ORT score ranges from 0 to 26. A score of 3 or lower indicates low risk for future opioid abuse, a score of 4 to 7 indicates moderate risk for opioid abuse, and a score of 8 or higher indicates a high risk for opioid abuse. | Hospital discharge (about 1 to 6 weeks after admission) | 
| Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility) | For this item of the Euro-QOL EQ-5D-3L questionnaire, participants are asked to indicate their level of mobility by choosing a predefined category, and the data for this outcome are reported categorically as the number of participants who chose each category. | Hospital discharge (about 1 to 6 weeks after admission) | 
| Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care) | For this item of the Euro-QOL EQ-5D-3L questionnaire, participants are asked to indicate their level of self-care by choosing a predefined category, and the data for this outcome are reported categorically as the number of participants who chose each category. | Hospital discharge (about 1 to 6 weeks after admission) | 
| Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities) | For this item of the Euro-QOL EQ-5D-3L questionnaire, participants are asked to indicate their ability to carry out usual activities by choosing a predefined category, and the data for this outcome are reported categorically as the number of participants who chose each category. | Hospital discharge (about 1 to 6 weeks after admission) | 
| Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort) | For this item of the Euro-QOL EQ-5D-3L questionnaire, participants are asked to indicate their level of pain/discomfort by choosing a predefined category, and the data for this outcome are reported categorically as the number of participants who chose each category. | Hospital discharge (about 1 to 6 weeks after admission) | 
| Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression) | For this item of the Euro-QOL EQ-5D-3L questionnaire, participants are asked to indicate their level of anxiety/depression by choosing a predefined category, and the data for this outcome are reported categorically as the number of participants who chose each category. | Hospital discharge (about 1 to 6 weeks after admission) | 
| Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Current Health) | For this item of the Euro-QOL EQ-5D-3L questionnaire, participants are asked the question How would you rate your health today?, and they respond with a score from 0 - 100, with a higher score indicating a better outcome. | Hospital discharge (about 1 to 6 weeks after admission) | 
| Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Previous Experience) | For this item of the Euro-QOL EQ-5D-3L questionnaire, participants are asked the question Have you ever experience this kind of event?, and data are reported as the number of participants who responded yes. | Hospital discharge (about 1 to 6 weeks after admission) | 
| Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility) | For this item of the Euro-QOL EQ-5D-3L questionnaire, participants are asked to indicate their level of mobility by choosing a predefined category, and the data for this outcome are reported categorically as the number of participants who chose each category. | 6 months post admission | 
| Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care) | For this item of the Euro-QOL EQ-5D-3L questionnaire, participants are asked to indicate their level of mobility by choosing a predefined category, and the data for this outcome are reported categorically as the number of participants who chose each category. | 6 months post admission | 
| Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities) | For this item of the Euro-QOL EQ-5D-3L questionnaire, participants are asked to indicate their ability to carry out usual activities by choosing a predefined category, and the data for this outcome are reported categorically as the number of participants who chose each category. | 6 months post admission | 
| Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort) | For this item of the Euro-QOL EQ-5D-3L questionnaire, participants are asked to indicate their level of pain/discomfort by choosing a predefined category, and the data for this outcome are reported categorically as the number of participants who chose each category. | 6 months post admission | 
| Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression) | For this item of the Euro-QOL EQ-5D-3L questionnaire, participants are asked to indicate their level of anxiety/depression by choosing a predefined category, and the data for this outcome are reported categorically as the number of participants who chose each category. | 6 months post admission | 
| Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Current Health) | For this item of the Euro-QOL EQ-5D-3L questionnaire, participants are asked the question How would you rate your health today?, and they respond with a score from 0 - 100, with a higher score indicating a better outcome. | 6 months post admission | 
| Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Previous Experience) | For this item of the Euro-QOL EQ-5D-3L questionnaire, participants are asked the question Have you ever experience this kind of event?, and data are reported as the number of participants who responded yes. | 6 months post admission | 
| Post Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire | The PC-PTSD-5 questionnaire asks the below 5 questions, and data are reported categorically as the number of participants who responded yes to each of the 5 questions. An answer of yes is indicative of a PTSD symptom, which is a worse outcome. In the past month, have you had nightmares about the events or thought about the events when you did not want to? In the past month, have you tried hard not to think about the events or went out of your way to avoid situations that reminded you of the events? In the past month, have you been constantly on guard, watchful, or easily startled? In the past month, have you felt numb or detached from people, activities, or your surroundings? In the past month, have you felt guilty or unable to stop blaming yourself or others for the events or any problems the events may have caused? | Hospital discharge (about 1 to 6 weeks after admission) | 
| Pain as Assessed by Score on the Behavioral Pain Scale (BPS) | BPS score ranges from 3-12, with higher scores indicating worse pain. This assessment is used in non-verbal participants. | Hospital discharge (up to 6 weeks post hospital admission) | 
| Pain as Assessed by Average Score on the Defense and Veterans Pain Rating Scale (DVPRS) | DVPRS scores were collected daily. For each participant, an average of the daily scores on the Defense and Veterans Pain Rating Scale was calculated. DVPRS scores range from 0 (no pain) to 10 (as bad as it could be, nothing else matters), with a higher score indicating a worse outcome. | From time of admission to time of discharge from hospital (about 1 to 6 weeks after admission) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multimodal Pain Therapy, Ketamine, Trauma