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Ketamine for Acute Pain Management After Trauma (KAPT)

Primary Purpose

Trauma Injury, Pain, Opioid Use

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Ketamine plus usual care

Usual Care

About this trial

This is an interventional treatment trial for Trauma Injury focused on measuring Multimodal Pain Therapy, Ketamine, Trauma

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ketamine plus Usual care

Usual care

Arm Description

Outcomes

Primary Outcome Measures

Average Daily Opioid Use as Measured by the Morphine Milligram Equivalents (MME) Per Day

Secondary Outcome Measures

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.

Number of Patients That Showed Signs of Delirium During In-hospital Stay

Incidence of delirium during in-hospital stay

Number of Patients That Required Unplanned Intubation During In-hospital Stay

incidence of need for unplanned intubation during in-hospital stay

Number of Patients Who Required Unplanned Admission to Intensive Care Unit During In-hospital Stay

Incidence of need for unplanned admission to an ICU

Initiation of Ketamine Drip

Time from admission to time Ketamine drip started

Duration of Ketamine Drip

Length of time Ketamine drip was infused

Number of Patients Requesting to Discontinue Ketamine

Number of patients requesting to stop Ketamine for any complaint

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

Ventilator Free Days

Number of inpatient hospital days patients did not require mechanical ventilation

ICU Free Days

Number of inpatient hospital days patients did not require ICU level of care

Hospital Free Days

Number of days patients were not in the hospital during the first 30 days after admission

Number of Patients Discharged From the Hospital With an Opioid Prescription

Number of patients discharged from the hospital with an opioid prescription

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

Number of Patients Who Continue to Use Opioids at 6 Months Post Admission

Number of patients who continue to use opioids

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?

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.

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.

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.

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.

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.

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.

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.

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."