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Completed

NCT Number: NCT04129086

Ketamine for Acute Pain Management After Trauma

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.

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Key information

Conditions

Trauma Injury Accidental Injuries Neurologic Manifestations Opioid Use Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ketamine plus usual care

Drug

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.

Usual Care

Drug

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.

Primary outcomes

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

    Time frame: In-hospital days (up to 6 weeks post hospital admission)

Secondary outcomes

  1. Pain as Assessed by Score on the Numeric Rating Scale (NRS)

    Time frame: Hospital discharge (up to 6 weeks post hospital admission)

    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.

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

    Time frame: Hospital discharge (up to 6 weeks post hospital admission)

    Incidence of delirium during in-hospital stay

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

    Time frame: Hospital discharge (up to 6 weeks post hospital admission)

    incidence of need for unplanned intubation during in-hospital stay

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

    Time frame: Hospital discharge (up to 6 weeks post hospital admission)

    Incidence of need for unplanned admission to an ICU

  5. Initiation of Ketamine Drip

    Time frame: Hospital discharge (up to 6 weeks post hospital admission)

    Time from admission to time Ketamine drip started

  6. Duration of Ketamine Drip

    Time frame: Hospital discharge (up to 6 weeks post hospital admission)

    Length of time Ketamine drip was infused

  7. Number of Patients Requesting to Discontinue Ketamine

    Time frame: Hospital discharge (up to 6 weeks post hospital admission)

    Number of patients requesting to stop Ketamine for any complaint

  8. Use of Other Pain Control Adjuncts Including Regional Anesthesia and Lidocaine Patch

    Time frame: Hospital discharge (up to 6 weeks post hospital admission)

    Incidence of use of additional pain control adjuncts such as regional anesthesia and lidocaine patch during hospitalization

  9. Ventilator Free Days

    Time frame: Hospital discharge (up to 6 weeks post hospital admission)

    Number of inpatient hospital days patients did not require mechanical ventilation

  10. ICU Free Days

    Time frame: Hospital discharge (up to 6 weeks post hospital admission)

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

  11. Hospital Free Days

    Time frame: 30 days post admission

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

  12. Number of Patients Discharged From the Hospital With an Opioid Prescription

    Time frame: Hospital discharge (up to 6 weeks post hospital admission)

    Number of patients discharged from the hospital with an opioid prescription

  13. Number of Patients Who Reported Continued Pain Continued Post-traumatic Pain at 6 Months Post Admission

    Time frame: 6 months post admission

    Number of patients who reported continued pain at 6 months following trauma injury

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

    Time frame: 6 months post admission

    Number of patients who continue to use opioids

  15. Post Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire

    Time frame: 6 months post admission

    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?

  16. Risk of Future Opioid Abuse as Assessed by the Opioid Risk Tool (ORT)

    Time frame: Hospital discharge (about 1 to 6 weeks after admission)

    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.

  17. Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility)

    Time frame: Hospital discharge (about 1 to 6 weeks after admission)

    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.

  18. Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care)

    Time frame: Hospital discharge (about 1 to 6 weeks after admission)

    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.

  19. Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities)

    Time frame: Hospital discharge (about 1 to 6 weeks after admission)

    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.

  20. Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort)

    Time frame: Hospital discharge (about 1 to 6 weeks after admission)

    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.

  21. Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression)

    Time frame: Hospital discharge (about 1 to 6 weeks after admission)

    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.

  22. Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Current Health)

    Time frame: Hospital discharge (about 1 to 6 weeks after admission)

    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.

  23. Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Previous Experience)

    Time frame: Hospital discharge (about 1 to 6 weeks after admission)

    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."

  24. Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility)

    Time frame: 6 months post admission

    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.

  25. Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care)

    Time frame: 6 months post admission

    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.

  26. Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities)

    Time frame: 6 months post admission

    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.

  27. Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort)

    Time frame: 6 months post admission

    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.

  28. Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression)

    Time frame: 6 months post admission

    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.

  29. Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Current Health)

    Time frame: 6 months post admission

    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.

  30. Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Previous Experience)

    Time frame: 6 months post admission

    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."

  31. Post Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire

    Time frame: Hospital discharge (about 1 to 6 weeks after admission)

    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?

  32. Pain as Assessed by Score on the Behavioral Pain Scale (BPS)

    Time frame: Hospital discharge (up to 6 weeks post hospital admission)

    BPS score ranges from 3-12, with higher scores indicating worse pain. This assessment is used in non-verbal participants.

  33. Pain as Assessed by Average Score on the Defense and Veterans Pain Rating Scale (DVPRS)

    Time frame: From time of admission to time of discharge from hospital (about 1 to 6 weeks after admission)

    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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

Ketamine for Acute Pain After Trauma: KAPT Trial

Acronym: KAPT

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 16, 2019
Registry last updated
Apr 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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