Hospital Inpatient Trauma InjuryNCT04274361
Ketamine for Pain Control After Severe Traumatic Injury
A study testing Ketamine in people with Hospital Inpatient Trauma Injury and Pain Management, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
This study evaluates if the early utilization of ketamine infusion therapy among acutely injured adult trauma hospital inpatients with an ISS >15 will decrease the amount of opioid pain medication used as compared with placebo group. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Hospital Inpatient Trauma Injury, Pain Management
- What is being tested?
- Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2021to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-64
- ISS >15
- Infusion can be started within 24 hrs of arrival to FMLH (time of injury irrelevant)
- Admitted to Inpatient hospital trauma service (not Ortho/Plastics/Neurosurgery etc)
Who cannot join
- Age <18 or >64
- History of adverse reaction to ketamine therapy
- Chronic opioid therapy defined as > 3 weeks of >30mg oral morphine equivalents per day
- Current substance abuse with opioids including prescription and/or heroin
- Intubation on arrival or need for urgent intubation on arrival
- GCS <13, significant traumatic brain injury, or suspicion of elevated intracranial pressure resulting in the patient's inability to communicate
Show all 16Show fewer
- History of psychosis
- Active delirium
- Glaucoma
- Ischemic heart disease defined as active acute coronary syndrome
- Severe, poorly controlled hypertension (SBP >200) on more than two readings
- Aortic Injury requiring HR and BP control
- Concurrent use of monoamine oxidase inhibitors (MAOIs)
- Pregnancy
- Prisoners
- Inability to start investigational drug infusion within 24 hours of arrival
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ketamine Infusion for Pain Control in Severe Traumatic Injury: a Randomized Controlled Trial
This study evaluates if the early utilization of ketamine infusion therapy among acutely injured adult trauma hospital inpatients with an ISS >15 will decrease the amount of opioid pain medication used as compared with placebo group. Ketamine infusion therapy initiated within 12 hours of hospital arrival will lead to decreased total opiate consumption (standardized to oral morphine equivalent units) in the first 24 and 48 hours compared to controls.
Read the detailed description
Traumatically injured hospital inpatients aged 18 - 64 will be enrolled into the study within 24 hours of admission to the hospital. The patients randomized to the experimental arm will receive early ketamine infusion therapy at a rate of 3 mcg/kg/min. All ketamine infusions will be calculated based on ideal body weight (IBW), unless actual body weight is less than ideal. IBW will be calculated for males as 50kg + 2.3*(number of inches above 5 feet) and for women as 45.5kg + 2.3*(number of inches over 5 feet). The 65 patients randomized to the control arm will receive placebo saline solution at a rate equivalent. Time zero will be defined as the time at which the "ketamine / placebo" infusion is begun. For inclusion in the study, initiation of ketamine / placebo infusions must take place within 12 hours of presentation to Froedtert Memorial Lutheran Hospital (FMLH).
Prior to starting the investigational infusion, a single IV push of 50mcg of fentanyl will be administered to any patient with a numeric pain score between 7-10. This is done to achieve more rapid pain control as poor pain control has been shown to lead to higher rates of chronic pain and PTSD.
Patient controlled analgesia will be provided using either morphine or hydromorphone with an initial starting dose of Morphine (1.5mg bolus, 12 min lockout, no continuous rate) or Hydromorphone (0.2mg, 12 min lockout, no continuous rate). Dose or lockout adjustments to the PCA should be done only after first adjusting the Investigational Drug dose. For example, if a patient continues to complain of severe pain (≥6) after 2-4 hours of initiation of the Investigational Drug then the rate of the infusion should be increased (as described below). The adjustments can be initiated by either the RAAPS team or Trauma service. No more than 1 change to PCA or Investigational Drug rate should be performed every 4 hours (ie if PCA was adjusted at midnight, then an adjustment to the Investigational Drug should not be made before 4 am).
At the completion of the 48-hour infusion the inpatient team has the option of transitioning the patient from the PCA to oral pain medications. Additional adjuncts to pain control including epidural or other regional techniques are at the discretion of the primary team but ideally would be delayed until the investigational infusion is completed.
Ketamine infusions will be prepared by the IDS service but will be hung and administered by the inpatient nursing staff. Ketamine infusion therapy will be continued for 48 hours. At 2-4 hours post-infusion the patient's pain will be reassessed. If the NPS is more than 5 the infusion will be increased to 5mcg/kg/min. Following each change in the infusion rate the patient's pain will be reassessed at 2-4 hours and adjustments made accordingly. Maximum infusion rate will be set at 9mcg/kg/min. Conversely, The RAAPS team should be notified if neurologic symptoms (hallucinations, delusions, disturbing dreams, vertigo) are developing and, at the discretion of the RAAPS service, a single dose of lorazepam or midazolam may be utilized. The infusion can be decreased from in 2 mcg/kg/min increments if there are symptoms believed to be related to the infusion that do not respond to benzodiazepines.
- Conditions
- Hospital Inpatient Trauma Injury, Pain Management
- Being tested
- Ketamine, Placebo
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Ketamine infusion
PlaceboDrug
Placebo infusion
| Study group | Role | What they receive |
|---|---|---|
| Ketamine arm | Experimental | Early ketamine infusion therapy at a rate of 3 mcg/kg/min. All ketamine infusions will be calculated based on ideal body weight (IBW), unless actual body weight is less than ideal. Ketamine infusion therapy will be continued for 48 hours. At 2-4 hours post-infusion the patient's pain will be reassessed. If the NPS is more than 5 the infusion will be increased to 5mcg/kg/min. Following each change in the infusion rate the patient's pain will be reassessed at 2-4 hours and adjustments made accordingly. Maximum infusion rate will be set at 9mcg/kg/min. Conversely, The RAAPS team should be notified if neurologic symptoms (hallucinations, delusions, disturbing dreams, vertigo) are developing and, at the discretion of the RAAPS service, a single dose of lorazepam or midazolam may be utilized. The infusion can be decreased from in 2 mcg/kg/min increments if there are symptoms believed to be related to the infusion that do not respond to benzodiazepines. Receives: Drug: Ketamine |
| Placebo arm | Placebo comparator | The 65 patients randomized to the control arm will receive placebo saline solution at a rate equivalent. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative opioid morphine equivalent dose
The cumulative OME will be compared within the two groups.
Measured: The first 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start20 Jan 2021
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hospital Inpatient Trauma InjuryStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Carver, Medical College of Wisconsin
- Investigators
- Thomas Carver, MD, Principal investigator, Medical College of WI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04274361
- Sponsor's protocol ID
- PRO#00037017
- Status last verified
- Jul 2024
- First submitted
- 14 Feb 2020
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Trevino CM, Carver T, Tomas C, Larson C, Mantz-Wichman M, Peppard WJ, deRoon-Cassini T. Acute traumatic pain treatment with ketamine decreased PTSD and anxiety symptoms 6 months post hospital discharge. J Trauma Acute Care Surg. 2026 Feb 1;100(2):215-220. doi: 10.1097/TA.0000000000004835. Epub 2025 Dec 17.
PubMed 41417647Carver TW, Peppard WJ, Gellings JA, Thapa R, Trevino C, Mantz-Wichman M, Peschman JR, Szabo A, Yang Y, Schroeder ME, Milia DJ, Elegbede AF, de Moya MA, de Roon-Cassini TA. Ketamine infusion for pain control in severely injured patients: Results of a randomized controlled trial. J Trauma Acute Care Surg. 2025 Jun 1;98(6):858-866. doi: 10.1097/TA.0000000000004602. Epub 2025 Mar 28.
PubMed 40152587Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for prevention of post-traumatic stress disorder (PTSD) in individuals experiencing acute traumatic stress symptoms. Cochrane Database Syst Rev. 2024 May 20;5(5):CD013613. doi: 10.1002/14651858.CD013613.pub2.
PubMed 38767196Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for universal prevention of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2022 Feb 10;2(2):CD013443. doi: 10.1002/14651858.CD013443.pub2.
PubMed 35141873
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine Infusion for Pain Control in Severe Traumatic Injury: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04274361
- Acronym / sponsor ID
- PRO#00037017
- Conditions
- Hospital Inpatient Trauma Injury, Pain Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 18 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates if the early utilization of ketamine infusion therapy among acutely injured adult trauma hospital inpatients with an ISS >15 will decrease the amount of opioid pain medication used as compared with placebo group. Ketamine infusion therapy initiated within 12 hours of hospital arrival will lead to decreased total opiate consumption (standardized to oral morphine equivalent units) in the first 24 and 48 hours compared to controls.
Detailed description
Traumatically injured hospital inpatients aged 18 - 64 will be enrolled into the study within 24 hours of admission to the hospital. The patients randomized to the experimental arm will receive early ketamine infusion therapy at a rate of 3 mcg/kg/min. All ketamine infusions will be calculated based on ideal body weight (IBW), unless actual body weight is less than ideal. IBW will be calculated for males as 50kg + 2.3*(number of inches above 5 feet) and for women as 45.5kg + 2.3*(number of inches over 5 feet). The 65 patients randomized to the control arm will receive placebo saline solution at a rate equivalent. Time zero will be defined as the time at which the "ketamine / placebo" infusion is begun. For inclusion in the study, initiation of ketamine / placebo infusions must take place within 12 hours of presentation to Froedtert Memorial Lutheran Hospital (FMLH).
Prior to starting the investigational infusion, a single IV push of 50mcg of fentanyl will be administered to any patient with a numeric pain score between 7-10. This is done to achieve more rapid pain control as poor pain control has been shown to lead to higher rates of chronic pain and PTSD.
Patient controlled analgesia will be provided using either morphine or hydromorphone with an initial starting dose of Morphine (1.5mg bolus, 12 min lockout, no continuous rate) or Hydromorphone (0.2mg, 12 min lockout, no continuous rate). Dose or lockout adjustments to the PCA should be done only after first adjusting the Investigational Drug dose. For example, if a patient continues to complain of severe pain (≥6) after 2-4 hours of initiation of the Investigational Drug then the rate of the infusion should be increased (as described below). The adjustments can be initiated by either the RAAPS team or Trauma service. No more than 1 change to PCA or Investigational Drug rate should be performed every 4 hours (ie if PCA was adjusted at midnight, then an adjustment to the Investigational Drug should not be made before 4 am).
At the completion of the 48-hour infusion the inpatient team has the option of transitioning the patient from the PCA to oral pain medications. Additional adjuncts to pain control including epidural or other regional techniques are at the discretion of the primary team but ideally would be delayed until the investigational infusion is completed.
Ketamine infusions will be prepared by the IDS service but will be hung and administered by the inpatient nursing staff. Ketamine infusion therapy will be continued for 48 hours. At 2-4 hours post-infusion the patient's pain will be reassessed. If the NPS is more than 5 the infusion will be increased to 5mcg/kg/min. Following each change in the infusion rate the patient's pain will be reassessed at 2-4 hours and adjustments made accordingly. Maximum infusion rate will be set at 9mcg/kg/min. Conversely, The RAAPS team should be notified if neurologic symptoms (hallucinations, delusions, disturbing dreams, vertigo) are developing and, at the discretion of the RAAPS service, a single dose of lorazepam or midazolam may be utilized. The infusion can be decreased from in 2 mcg/kg/min increments if there are symptoms believed to be related to the infusion that do not respond to benzodiazepines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine arm | Experimental | Drug: KetamineEarly ketamine infusion therapy at a rate of 3 mcg/kg/min. All ketamine infusions will be calculated based on ideal body weight (IBW), unless actual body weight is less than ideal. Ketamine infusion therapy will be continued for 48 hours. At 2-4 hours post-infusion the patient's pain will be reassessed. If the NPS is more than 5 the infusion will be increased to 5mcg/kg/min. Following each change in the infusion rate the patient's pain will be reassessed at 2-4 hours and adjustments made accordingly. Maximum infusion rate will be set at 9mcg/kg/min. Conversely, The RAAPS team should be notified if neurologic symptoms (hallucinations, delusions, disturbing dreams, vertigo) are developing and, at the discretion of the RAAPS service, a single dose of lorazepam or midazolam may be utilized. The infusion can be decreased from in 2 mcg/kg/min increments if there are symptoms believed to be related to the infusion that do not respond to benzodiazepines. |
| Placebo arm | Placebo comparator | Drug: PlaceboThe 65 patients randomized to the control arm will receive placebo saline solution at a rate equivalent. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-64
- ISS >15
- Infusion can be started within 24 hrs of arrival to FMLH (time of injury irrelevant)
- Admitted to Inpatient hospital trauma service (not Ortho/Plastics/Neurosurgery etc)
Key exclusion criteria (16 listed)
- Age <18 or >64
- History of adverse reaction to ketamine therapy
- Chronic opioid therapy defined as > 3 weeks of >30mg oral morphine equivalents per day
- Current substance abuse with opioids including prescription and/or heroin
- Intubation on arrival or need for urgent intubation on arrival
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 |
|---|---|---|
| KetamineKetamine infusion | Drug | Ketamine arm |
| PlaceboPlacebo infusion | Drug | Placebo arm |
Primary outcome
Cumulative opioid morphine equivalent dose
Time frame: The first 24 hours
The cumulative OME will be compared within the two groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Derived from this study: PubMed 41417647Trevino CM, Carver T, Tomas C, Larson C, Mantz-Wichman M, Peppard WJ, deRoon-Cassini T. Acute traumatic pain treatment with ketamine decreased PTSD and anxiety symptoms 6 months post hospital discharge. J Trauma Acute Care Surg. 2026 Feb 1;100(2):215-220. doi: 10.1097/TA.0000000000004835. Epub 2025 Dec 17.
- Derived from this study: PubMed 40152587Carver TW, Peppard WJ, Gellings JA, Thapa R, Trevino C, Mantz-Wichman M, Peschman JR, Szabo A, Yang Y, Schroeder ME, Milia DJ, Elegbede AF, de Moya MA, de Roon-Cassini TA. Ketamine infusion for pain control in severely injured patients: Results of a randomized controlled trial. J Trauma Acute Care Surg. 2025 Jun 1;98(6):858-866. doi: 10.1097/TA.0000000000004602. Epub 2025 Mar 28.
- Derived from this study: PubMed 38767196Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for prevention of post-traumatic stress disorder (PTSD) in individuals experiencing acute traumatic stress symptoms. Cochrane Database Syst Rev. 2024 May 20;5(5):CD013613. doi: 10.1002/14651858.CD013613.pub2.
- Derived from this study: PubMed 35141873Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for universal prevention of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2022 Feb 10;2(2):CD013443. doi: 10.1002/14651858.CD013443.pub2.
- Individual participant dataSharing planned: No
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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.
Thomas Carver, MD principal investigator
Medical College of WI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine in people with Hospital Inpatient Trauma Injury and Pain Management, run by Medical College of Wisconsin 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 4 inclusion and 16 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 14 Mar 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cumulative opioid morphine equivalent dose (time frame: The first 24 hours). 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 NCT04274361, which also lists 4 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 14 Mar 2025.