Ketamine for Acute Pain Management After Trauma

Brief Summary

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.

Intervention / Treatment

  • 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.

Condition or Disease

  • Trauma Injury
  • Pain
  • Opioid Use

Phase

  • Phase 4
  • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 16 Years and older   (Child, Adult, Older Adult)
    Enrollment: 305 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    SINGLE:
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Jul 01, 2020 ACTUAL
    Primary Completion: Mar 30, 2022 ACTUAL
    Completion Date: Sep 30, 2022 ACTUAL
    Study First Posted: Oct 16, 2019 ACTUAL
    Results First Posted: Apr 21, 2023 ACTUAL
    Last Updated: Mar 30, 2023

    Sponsors / Collaborators

    Responsible Party: N/A

    Participant Groups

    • No description provided

    • No description provided

    Eligibility Criteria

    Sex: All
    Minimum Age: 16
    Age Groups: Child / Adult / Older Adult
    Healthy Volunteers: Yes

    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)

    Primary Outcomes
    • 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 Outcomes
    • 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.

    • Incidence of delirium during in-hospital stay

    • incidence of need for unplanned intubation during in-hospital stay

    • Incidence of need for unplanned admission to an ICU

    • Time from admission to time Ketamine drip started

    • Length of time Ketamine drip was infused

    • Number of patients requesting to stop Ketamine for any complaint

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

    • Number of inpatient hospital days patients did not require mechanical ventilation

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

    • 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 who reported continued pain at 6 months following trauma injury

    • Number of patients who continue to use opioids

    • 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. 1. In the past month, have you had nightmares about the events or thought about the events when you did not want to? 2. 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? 3. In the past month, have you been constantly on guard, watchful, or easily startled? 4. In the past month, have you felt numb or detached from people, activities, or your surroundings? 5. 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?

    • 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.

    • 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.

    • 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.

    • 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.

    • 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.

    • 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.

    • 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.

    • 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."

    • 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.

    • 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.

    • 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.

    • 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.

    • 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.

    • 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.

    • 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."

    • 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. 1. In the past month, have you had nightmares about the events or thought about the events when you did not want to? 2. 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? 3. In the past month, have you been constantly on guard, watchful, or easily startled? 4. In the past month, have you felt numb or detached from people, activities, or your surroundings? 5. 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?

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

    • 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.

    More Details

    NCT Number: NCT04129086
    Acronym: KAPT
    Other IDs: HSC-MS-19-0726
    Study URL: https://clinicaltrials.gov/study/NCT04129086
    Last updated: Sep 29, 2023