Clinical trial NCT04129086: Ketamine for Acute Pain Management After Trauma
Official title: Ketamine for Acute Pain After Trauma: KAPT Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Trauma Injury
Pain
Opioid Use
Keywords: Multimodal Pain Therapy
Ketamine
Trauma
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2019-10-16
Enrollment: 305
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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:
measure: Average Daily Opioid Use as Measured by the Morphine Milligram Equivalents (MME) Per Day
timeFrame: In-hospital days (up to 6 weeks post hospital admission)
Secondary outcomes:
measure: Pain as Assessed by Score on the Numeric Rating Scale (NRS)
timeFrame: Hospital discharge (up to 6 weeks post hospital admission)
measure: Number of Patients That Showed Signs of Delirium During In-hospital Stay
timeFrame: Hospital discharge (up to 6 weeks post hospital admission)
measure: Number of Patients That Required Unplanned Intubation During In-hospital Stay
timeFrame: Hospital discharge (up to 6 weeks post hospital admission)
measure: Number of Patients Who Required Unplanned Admission to Intensive Care Unit During In-hospital Stay
timeFrame: Hospital discharge (up to 6 weeks post hospital admission)
measure: Initiation of Ketamine Drip
timeFrame: Hospital discharge (up to 6 weeks post hospital admission)
measure: Duration of Ketamine Drip
timeFrame: Hospital discharge (up to 6 weeks post hospital admission)
measure: Number of Patients Requesting to Discontinue Ketamine
timeFrame: Hospital discharge (up to 6 weeks post hospital admission)
measure: Use of Other Pain Control Adjuncts Including Regional Anesthesia and Lidocaine Patch
timeFrame: Hospital discharge (up to 6 weeks post hospital admission)
measure: Ventilator Free Days
timeFrame: Hospital discharge (up to 6 weeks post hospital admission)
measure: ICU Free Days
timeFrame: Hospital discharge (up to 6 weeks post hospital admission)
measure: Hospital Free Days
timeFrame: 30 days post admission
measure: Number of Patients Discharged From the Hospital With an Opioid Prescription
timeFrame: Hospital discharge (up to 6 weeks post hospital admission)
measure: Number of Patients Who Reported Continued Pain Continued Post-traumatic Pain at 6 Months Post Admission
timeFrame: 6 months post admission
measure: Number of Patients Who Continue to Use Opioids at 6 Months Post Admission
timeFrame: 6 months post admission
measure: Post Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire
timeFrame: 6 months post admission
measure: Risk of Future Opioid Abuse as Assessed by the Opioid Risk Tool (ORT)
timeFrame: Hospital discharge (about 1 to 6 weeks after admission)
measure: Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility)
timeFrame: Hospital discharge (about 1 to 6 weeks after admission)
measure: Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care)
timeFrame: Hospital discharge (about 1 to 6 weeks after admission)
measure: Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities)
timeFrame: Hospital discharge (about 1 to 6 weeks after admission)
measure: Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort)
timeFrame: Hospital discharge (about 1 to 6 weeks after admission)
measure: Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression)
timeFrame: Hospital discharge (about 1 to 6 weeks after admission)
measure: Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Current Health)
timeFrame: Hospital discharge (about 1 to 6 weeks after admission)
measure: Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Previous Experience)
timeFrame: Hospital discharge (about 1 to 6 weeks after admission)
measure: Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility)
timeFrame: 6 months post admission
measure: Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care)
timeFrame: 6 months post admission
measure: Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities)
timeFrame: 6 months post admission
measure: Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort)
timeFrame: 6 months post admission
measure: Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression)
timeFrame: 6 months post admission
measure: Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Current Health)
timeFrame: 6 months post admission
measure: Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Previous Experience)
timeFrame: 6 months post admission
measure: Post Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire
timeFrame: Hospital discharge (about 1 to 6 weeks after admission)
measure: Pain as Assessed by Score on the Behavioral Pain Scale (BPS)
timeFrame: Hospital discharge (up to 6 weeks post hospital admission)
measure: Pain as Assessed by Average Score on the Defense and Veterans Pain Rating Scale (DVPRS)
timeFrame: From time of admission to time of discharge from hospital (about 1 to 6 weeks after admission)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: John P Harvin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.