Ketamine for Acute Pain Management After Trauma

Phase 4

Completed

Conditions: Pain
Opioid Use
Trauma Injury

Interventions: Drug: Usual Care
Drug: Ketamine plus usual care

Registration Number: NCT04129086

Lead Sponsor: The University of Texas Health Science Center, Houston

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 available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 305

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care	Usual Care	-
Ketamine plus Usual care	Ketamine plus usual care	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Risk of Future Opioid Abuse as Assessed by the Opioid Risk Tool (ORT)	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.
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility)	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.
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care)	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.
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities)	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.
Number of Patients That Showed Signs of Delirium During In-hospital Stay	Hospital discharge (up to 6 weeks post hospital admission)	Incidence of delirium during in-hospital stay
Duration of Ketamine Drip	Hospital discharge (up to 6 weeks post hospital admission)	Length of time Ketamine drip was infused
Pain as Assessed by Score on the Numeric Rating Scale (NRS)	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.
Number of Patients Who Required Unplanned Admission to Intensive Care Unit During In-hospital Stay	Hospital discharge (up to 6 weeks post hospital admission)	Incidence of need for unplanned admission to an ICU
Use of Other Pain Control Adjuncts Including Regional Anesthesia and Lidocaine Patch	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
ICU Free Days	Hospital discharge (up to 6 weeks post hospital admission)	Number of inpatient hospital days patients did not require ICU level of care
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Current Health)	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.
Initiation of Ketamine Drip	Hospital discharge (up to 6 weeks post hospital admission)	Time from admission to time Ketamine drip started
Ventilator Free Days	Hospital discharge (up to 6 weeks post hospital admission)	Number of inpatient hospital days patients did not require mechanical ventilation
Number of Patients Discharged From the Hospital With an Opioid Prescription	Hospital discharge (up to 6 weeks post hospital admission)	Number of patients discharged from the hospital with an opioid prescription
Number of Patients Who Continue to Use Opioids at 6 Months Post Admission	6 months post admission	Number of patients who continue to use opioids
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort)	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.
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression)	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.
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Previous Experience)	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."
Number of Patients That Required Unplanned Intubation During In-hospital Stay	Hospital discharge (up to 6 weeks post hospital admission)	incidence of need for unplanned intubation during in-hospital stay
Number of Patients Requesting to Discontinue Ketamine	Hospital discharge (up to 6 weeks post hospital admission)	Number of patients requesting to stop Ketamine for any complaint
Pain as Assessed by Score on the Behavioral Pain Scale (BPS)	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.
Hospital Free Days	30 days post admission	Number of days patients were not in the hospital during the first 30 days after admission
Number of Patients Who Reported Continued Pain Continued Post-traumatic Pain at 6 Months Post Admission	6 months post admission	Number of patients who reported continued pain at 6 months following trauma injury
Post Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire	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. 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?
Pain as Assessed by Average Score on the Defense and Veterans Pain Rating Scale (DVPRS)	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.