Ketamine for Acute Pain Management After Trauma (KAPT)

Ketamine for Acute Pain After Trauma: KAPT Trial

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.

Study Overview

• Status: Completed
• Conditions: Pain; Trauma Injury; Opioid Use
• Intervention / Treatment: Drug: Ketamine plus usual care; Drug: Usual Care

• Study Type: Interventional
• Enrollment (Actual): 305
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual care	Drug: Usual 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.
Experimental: Ketamine plus Usual care	Drug: Ketamine plus usual care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: John P Harvin, MD, The University of Texas Health Science Center, Houston

Publications and helpful links

General Publications

• Puzio TJ, Klugh J, Wandling MW, Green C, Balogh J, Prater SJ, Stephens CT, Sergot PB, Wade CE, Kao LS, Harvin JA. Ketamine for acute pain after trauma: the KAPT randomized controlled trial. Trials. 2022 Jul 27;23(1):599. doi: 10.1186/s13063-022-06511-6.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): March 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: October 10, 2019
• First Submitted That Met QC Criteria: October 14, 2019
• First Posted (Actual): October 16, 2019

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Ketamine; Trauma; Multimodal Pain Therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Acute Pain; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: HSC-MS-19-0726

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No