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Trial · NCT04129086

Registered outcomes34

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryAverage Daily Opioid Use as Measured by the Morphine Milligram Equivalents (MME) Per DayIn-hospital days (up to 6 weeks post hospital admission)
SecondaryPain 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.
SecondaryNumber of Patients That Showed Signs of Delirium During In-hospital StayHospital discharge (up to 6 weeks post hospital admission)Incidence of delirium during in-hospital stay
SecondaryNumber of Patients That Required Unplanned Intubation During In-hospital StayHospital discharge (up to 6 weeks post hospital admission)incidence of need for unplanned intubation during in-hospital stay
SecondaryNumber of Patients Who Required Unplanned Admission to Intensive Care Unit During In-hospital StayHospital discharge (up to 6 weeks post hospital admission)Incidence of need for unplanned admission to an ICU
SecondaryInitiation of Ketamine DripHospital discharge (up to 6 weeks post hospital admission)Time from admission to time Ketamine drip started
SecondaryDuration of Ketamine DripHospital discharge (up to 6 weeks post hospital admission)Length of time Ketamine drip was infused
SecondaryNumber of Patients Requesting to Discontinue KetamineHospital discharge (up to 6 weeks post hospital admission)Number of patients requesting to stop Ketamine for any complaint
SecondaryUse of Other Pain Control Adjuncts Including Regional Anesthesia and Lidocaine PatchHospital 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
SecondaryVentilator Free DaysHospital discharge (up to 6 weeks post hospital admission)Number of inpatient hospital days patients did not require mechanical ventilation
SecondaryICU Free DaysHospital discharge (up to 6 weeks post hospital admission)Number of inpatient hospital days patients did not require ICU level of care
SecondaryHospital Free Days30 days post admissionNumber of days patients were not in the hospital during the first 30 days after admission
SecondaryNumber of Patients Discharged From the Hospital With an Opioid PrescriptionHospital discharge (up to 6 weeks post hospital admission)Number of patients discharged from the hospital with an opioid prescription
SecondaryNumber of Patients Who Reported Continued Pain Continued Post-traumatic Pain at 6 Months Post Admission6 months post admissionNumber of patients who reported continued pain at 6 months following trauma injury
SecondaryNumber of Patients Who Continue to Use Opioids at 6 Months Post Admission6 months post admissionNumber of patients who continue to use opioids
SecondaryPost Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire6 months post 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?
SecondaryRisk 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.
SecondaryHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility)Hospital discharge (about 1 to 6 weeks after 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.
SecondaryHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care)Hospital discharge (about 1 to 6 weeks after admission)
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.
SecondaryHealth Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities)Hospital discharge (about 1 to 6 weeks after 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.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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