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Ketamine for Acute Pain Management After Trauma (KAPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04129086
Recruitment Status : Active, not recruiting
First Posted : October 16, 2019
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
John Andrew Harvin, The University of Texas Health Science Center, Houston

Tracking Information
First Submitted Date  ICMJE October 10, 2019
First Posted Date  ICMJE October 16, 2019
Last Update Posted Date March 2, 2022
Actual Study Start Date  ICMJE July 1, 2020
Estimated Primary Completion Date August 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2019)
Average daily opioid use as measured by the Morphine Milligram Equivalents per day [ Time Frame: In-hospital days (up to 6 weeks post hospital admission) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2019)
  • In-hospital pain scores [ Time Frame: Hospital discharge(up to 6 weeks post hospital admission) ]
    Daily pain scores on a numeric scale from 0 - 10 during in-hospital stay
  • 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
  • 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
  • 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
  • Initiation of Ketamine drip [ Time Frame: Hospital discharge(up to 6 weeks post hospital admission) ]
    Time from admission to time Ketamine drip started
  • Duration of Ketamine drip [ Time Frame: Hospital discharge(up to 6 weeks post hospital admission) ]
    Length of time Ketamine drip was infused
  • 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
  • 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
  • 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
  • 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
  • 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
  • Discharge from hospital with opioid prescription [ Time Frame: Hospital discharge(up to 6 weeks post hospital admission) ]
    Number of patients discharged from the hospital with an opioid prescription
  • Health status at hospital discharge [ Time Frame: Hospital discharge (about 1 to 6 weeks) ]
    Health status measured by the patients' answers to the EuroQol-5D-5L questionnaire which is based in a scale from 0 - 100 with higher scores indicating a better outcome.
  • Health status 6 months post admission [ Time Frame: 6 months post admission ]
    Health status measured by the patients' answers to the EuroQol-5D-5L questionnaire which is based in a scale from 0 - 100 with higher scores indicating a better outcome.
  • Presence of 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
  • Persistent opioid use at 6 months post admission [ Time Frame: 6 months post admission ]
    Number of patients who continue to use opioids
  • Post traumatic Stress Disorder (PTSD) screening measured by patients' answers to the PC-PTSD-5 questionnaire at 6 months. [ Time Frame: 6 months post admission ]
    Post traumatic screening status measured by the patients' answers to the PC-PTSD-5. The questionnaire is measured on a scale from 0-5 higher the score the more likely to be prone to PTSD.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine for Acute Pain Management After Trauma
Official Title  ICMJE Ketamine for Acute Pain After Trauma: KAPT Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Trauma Injury
  • Pain
  • Opioid Use
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Ketamine plus Usual care
    Intervention: Drug: Ketamine plus usual care
  • Active Comparator: Usual care
    Intervention: Drug: Usual Care
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 14, 2019)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 1, 2023
Estimated Primary Completion Date August 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04129086
Other Study ID Numbers  ICMJE HSC-MS-19-0726
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party John Andrew Harvin, The University of Texas Health Science Center, Houston
Original Responsible Party Same as current
Current Study Sponsor  ICMJE The University of Texas Health Science Center, Houston
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John P Harvin, MD The University of Texas Health Science Center, Houston
PRS Account The University of Texas Health Science Center, Houston
Verification Date February 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP