Trauma InjuryPhase 4KAPTNCT04129086
Ketamine for Acute Pain Management After Trauma
A Phase 4 study of Trauma Injury and Pain, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Trauma Injury, Pain, Opioid Use
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 305 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 30 Sep 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult trauma patients
- Admission to Shock Trauma ICU (STICU) or Surgical Intermediate Unit (SIMU)
- Randomization within 6 hours of arrival
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: 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.
- Conditions
- Trauma Injury, Pain, Opioid Use
- Being tested
- Ketamine plus usual care, Usual Care
- Keywords
- Multimodal Pain Therapy, Ketamine, Trauma
- Medical subject headings
- Accidental Injuries, Pain, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine plus usual careDrug
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.
Usual CareDrug
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 group | Role | What they receive |
|---|---|---|
| Ketamine plus Usual care | Experimental | Not described Receives: Drug: Ketamine plus usual care |
| Usual care | Active comparator | Not described Receives: Drug: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Daily Opioid Use as Measured by the Morphine Milligram Equivalents (MME) Per Day
Measured: In-hospital days (up to 6 weeks post hospital admission)
Secondary outcomes (33)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: Hospital discharge (up to 6 weeks post hospital admission)
Initiation of Ketamine Drip
Time from admission to time Ketamine drip started
Measured: Hospital discharge (up to 6 weeks post hospital admission)
Duration of Ketamine Drip
Length of time Ketamine drip was infused
Measured: 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
Measured: 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
Measured: Hospital discharge (up to 6 weeks post hospital admission)
Ventilator Free Days
Number of inpatient hospital days patients did not require mechanical ventilation
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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?
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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."
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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."
Measured: 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?
Measured: 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.
Measured: 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.
Measured: From time of admission to time of discharge from hospital (about 1 to 6 weeks after admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start1 Jul 2020
- Primary completion30 Mar 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Trauma InjuryStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Andrew Harvin, The University of Texas Health Science Center, Houston
- Investigators
- John P Harvin, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129086
- Sponsor's protocol ID
- HSC-MS-19-0726
- Acronym
- KAPT
- Status last verified
- Mar 2023
- First submitted
- 10 Oct 2019
- Last updated
- 21 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Klugh JM, Puzio TJ, Wandling MW, Guy-Frank CJ, Green C, Sergot PB, Prater SJ, Balogh J, Stephens CT, Wade CE, Kao LS, Harvin JA. Ketamine for acute pain after trauma: A pragmatic, randomized clinical trial. J Trauma Acute Care Surg. 2024 Oct 1;97(4):514-519. doi: 10.1097/TA.0000000000004325. Epub 2024 May 1.
PubMed 38689402Puzio 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.
PubMed 35897081
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine for Acute Pain After Trauma: KAPT Trial
- ClinicalTrials.gov ID
- NCT04129086
- Acronym / sponsor ID
- KAPT / HSC-MS-19-0726
- Conditions
- Trauma Injury, Pain, Opioid Use
- Keywords
- Multimodal Pain Therapy, Ketamine, Trauma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 16 Oct 2019 (actual)
- Results
- Posted 21 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine plus Usual care | Experimental | Drug: Ketamine plus usual care |
| Usual care | Active comparator | Drug: Usual Care |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Adult trauma patients
- Admission to Shock Trauma ICU (STICU) or Surgical Intermediate Unit (SIMU)
- Randomization within 6 hours of arrival
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine plus usual careBolus 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 | Ketamine plus Usual care |
| Usual CareStandard 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 |
Primary outcome
Average Daily Opioid Use as Measured by the Morphine Milligram Equivalents (MME) Per Day
Time frame: In-hospital days (up to 6 weeks post hospital admission)
33 secondary outcomes
Pain as Assessed by Score on the Numeric Rating Scale (NRS)
Time frame: Hospital discharge (up to 6 weeks post hospital admission)
Number of Patients That Showed Signs of Delirium During In-hospital Stay
Time frame: Hospital discharge (up to 6 weeks post hospital admission)
Number of Patients That Required Unplanned Intubation During In-hospital Stay
Time frame: Hospital discharge (up to 6 weeks post hospital admission)
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)
Initiation of Ketamine Drip
Time frame: Hospital discharge (up to 6 weeks post hospital admission)
Duration of Ketamine Drip
Time frame: Hospital discharge (up to 6 weeks post hospital admission)
Number of Patients Requesting to Discontinue Ketamine
Time frame: Hospital discharge (up to 6 weeks post hospital admission)
Use of Other Pain Control Adjuncts Including Regional Anesthesia and Lidocaine Patch
Time frame: Hospital discharge (up to 6 weeks post hospital admission)
Ventilator Free Days
Time frame: Hospital discharge (up to 6 weeks post hospital admission)
ICU Free Days
Time frame: Hospital discharge (up to 6 weeks post hospital admission)
Hospital Free Days
Time frame: 30 days post admission
Number of Patients Discharged From the Hospital With an Opioid Prescription
Time frame: 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
Time frame: 6 months post admission
Number of Patients Who Continue to Use Opioids at 6 Months Post Admission
Time frame: 6 months post admission
Post Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire
Time frame: 6 months post admission
Risk of Future Opioid Abuse as Assessed by the Opioid Risk Tool (ORT)
Time frame: Hospital discharge (about 1 to 6 weeks after admission)
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility)
Time frame: Hospital discharge (about 1 to 6 weeks after admission)
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care)
Time frame: Hospital discharge (about 1 to 6 weeks after admission)
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities)
Time frame: Hospital discharge (about 1 to 6 weeks after admission)
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort)
Time frame: Hospital discharge (about 1 to 6 weeks after admission)
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression)
Time frame: Hospital discharge (about 1 to 6 weeks after admission)
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Current Health)
Time frame: Hospital discharge (about 1 to 6 weeks after admission)
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Previous Experience)
Time frame: Hospital discharge (about 1 to 6 weeks after admission)
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility)
Time frame: 6 months post admission
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care)
Time frame: 6 months post admission
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities)
Time frame: 6 months post admission
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort)
Time frame: 6 months post admission
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression)
Time frame: 6 months post admission
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Current Health)
Time frame: 6 months post admission
Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Previous Experience)
Time frame: 6 months post admission
Post Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire
Time frame: Hospital discharge (about 1 to 6 weeks after admission)
Pain as Assessed by Score on the Behavioral Pain Scale (BPS)
Time frame: Hospital discharge (up to 6 weeks post hospital admission)
Pain as Assessed by Average Score on the Defense and Veterans Pain Rating Scale (DVPRS)
Time frame: From time of admission to time of discharge from hospital (about 1 to 6 weeks after admission)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38689402Klugh JM, Puzio TJ, Wandling MW, Guy-Frank CJ, Green C, Sergot PB, Prater SJ, Balogh J, Stephens CT, Wade CE, Kao LS, Harvin JA. Ketamine for acute pain after trauma: A pragmatic, randomized clinical trial. J Trauma Acute Care Surg. 2024 Oct 1;97(4):514-519. doi: 10.1097/TA.0000000000004325. Epub 2024 May 1.
- Derived from this study: PubMed 35897081Puzio 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.
- Individual participant dataSharing planned: No
Related trials for Trauma Injury
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John P Harvin, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Trauma Injury and Pain, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Daily Opioid Use as Measured by the Morphine Milligram Equivalents (MME) Per Day (time frame: In-hospital days (up to 6 weeks post hospital admission)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04129086, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.