Blunt Injury of ThoraxPhase 4NCT06236113
Low Dose Ketamine for Blunt Thoracic Trauma
A Phase 4 study testing Ketamine 1 Mg/mL-NaCl 0.9% Intravenous Solution in people with Blunt Injury of Thorax and Multiple Rib Fractures, Involving Three Ribs, run by North Memorial Health Care at 1 site in United States.
Trial summary
The goal of this Randomized controlled double-blinded trial is to compare the addition of a ketamine infusion to placebo, when added to standard care in adult blunt trauma patients with multiple rib fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blunt Injury of Thorax, Multiple Rib Fractures, Involving Three Ribs
- What is being tested?
- Ketamine 1 Mg/mL-NaCl 0.9% Intravenous Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 26 Jun 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females 18 years of age or older
- Diagnosis of 3 or more acute rib fractures related to blunt traumatic chest injury.
- Able to undergo consent procedure and give valid consent, or availability of family member to provide consent for the study
Who cannot join
- Age <18 years
- Cognitively impaired
- Pregnant or lactating females.
- Glasgow Coma Score (GCS) of ≤ 14 at time of admission
- Evidence of increased intraocular pressure
- Presence of acute coronary syndrome
Show all 14Show fewer
- Diagnosed moderate to severe traumatic brain injury
- Evidence of uncontrolled intracranial hypertension
- History of seizures or stroke
- History of severe psychiatric disorders
- Allergy to ketamine
- Currently being treated, prior to admission, with opiate agonist/antagonist therapy
- Presence of poorly controlled hypertension, cardiac arrhythmias, and/or tachycardia on admission
- Subjects who, in the opinion of the Investigator, may be inappropriate for study participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
North Memorial Health Hospital
Robbinsdale, Minnesota, 55422
About this study
Official title: Low Dose Ketamine for Blunt Thoracic Trauma: A Prospective Randomized Trial
The goal of this Randomized controlled double-blinded trial is to compare the addition of a ketamine infusion to placebo, when added to standard care in adult blunt trauma patients with multiple rib fractures. The main question it aims to answer are: • addition of low dose ketamine infusion (LDKI) decreases narcotic use • does LDKI impact pulmonary complications, readmission, or hospital length of stay Participants will receive usual standard of care with up to 48 hours of LDKI or placebo. If there is a comparison group: Researchers will compare infusion of a saline infusion to LDKI to see if LDKI decreases need for narcotic analgesics use.
Read the detailed description
Study Design: Randomized controlled double-blinded trial: Patients will then be randomized into one of two study groups. Both groups will receive a normal saline infusion for 48 hours of therapy. The treatment group will have ketamine added to their saline infusion via blinded pharmacy protocol to receive continuous infusion of ketamine at 0.1mg/kg/hour. The control group will receive only normal saline. Administration will occur via piggyback infusion in accordance with nursing policy.
Setting/Participants:
- North Memorial Health Hospital: patients on 5-South - Trauma Neuro Intensive Care Unit (TNICU) and 6-West - Trauma Floor
- 50 people will take part in this study. 25 study subjects will receive an infusion of ketamine and 25 will receive a saline infusion.
- Patients 18 years of age or older with 3 or more rib fractures admitted to North Memorial Health Hospital will be considered for the study.
Study Interventions and Measures:
- Ketamine low-dose infusion administered at 0.1 mg/kg/hr for 48 hours as an adjunct to standardized rib fracture management interventions as outlined in facility-approved Guidelines for Rib Fracture Management.
- The primary study outcome will be amount of narcotic used over the 48-hour study period (expressed as morphine mg equivalents).
- Secondary outcome measures will include: need for endotracheal intubation or non-invasive positive pressure ventilation, oxygen requirements, daily incentive spirometer values, daily forced vital capacity measurements, and subjective patient pain ratings.
- Other outcomes measured will be Intensive Care Unit stay, total hospital length of stay, and adverse medication effects.
- Being tested
- Ketamine 1 Mg/mL-NaCl 0.9% Intravenous Solution
- Keywords
- Blunt Thoracic Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine 1 Mg/mL-NaCl 0.9% Intravenous SolutionDrug
Also called Low Dose Ketamine Infusion, Ketamine Drip
administered at rate of 0.1 mg/kg/hr
| Study group | Role | What they receive |
|---|---|---|
| Placebo/Control | Placebo comparator | Pharmacist will check randomization schedule. For placebo/control subject they will prepare an infusion bag of saline with no added medication. The Study Drug Bag will be released with a label that includes: Name of Study, Study Subject #, Patient (Pt) Name, Pt Medical record number (MR#), Pt Date of birth (DOB), and INFUSION RATE. Receives: Drug: Ketamine 1 Mg/mL-NaCl 0.9% Intravenous Solution |
| Low Dose Ketamine Infusion (LDKI) | Experimental | Infusion Bag will receive 100 mg of ketamine (Ketamine Infusion Subject). The Study Drug Bag will be released with a label that includes: Name of Study, Study Subject #, Patient Name, Pt MR#, Pt DOB, and INFUSION RATE. (Note: infusion rate is 0.1 mg/kg/hr and concentration of standard ketamine infusion bag is 1 mg/mL. That is, 100 mg of ketamine added to 100 mL saline). Receives: Drug: Ketamine 1 Mg/mL-NaCl 0.9% Intravenous Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Milligrams of Morphine Equivalents (MME) Administered
Standardized method of reporting narcotic analgesic administration by converting opioid narcotics to the equivalent dosage of morphine that would yield same result.
Measured: Outcome was evaluated up to a total of 96 hours (from time zero to 48 hours of infusion and up to 48 hrs after infusion stopped.
Secondary outcomes (2)
Pulmonary Complications
Number of participants that develop pneumonia, require intubation, or non-invasive positive pressure ventilation
Measured: Up to 30 days after intervention (administration of study drug)
ICU Admission or Hospital Readmission
Number of participants that requirie transfer to ICU (e.g., respiratory difficulty, tachycardia, hypotension, altered mental status) or that readmission to hospital after discharge for any reason.
Measured: Up to 30 days after intervention (administration of study drug)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start1 Oct 2021
- Primary completion19 Mar 2023
- Study completion26 Jun 2023
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 (1)Papers the sponsor has linked to this study.
- Other trials for Blunt Injury of ThoraxStudies of the same condition, open and under way.
- 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
- Model description
- prospective, randomized, double-blinded, placebo-controlled study comparing saline infusion with low-dose ketamine versus saline infusion alone.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Memorial Health Care
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michaela A West, North Memorial Health Care
- Investigators
- Michaela A West, MD, PhD, Study director, North Memorial HealthJoseph Farhat, MD, Principal investigator, North Memorial Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236113
- Sponsor's protocol ID
- 04/18/46
- Status last verified
- May 2024
- First submitted
- 12 Jan 2024
- Last updated
- 21 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Walters MK, Farhat J, Bischoff J, Foss M, Evans C. Ketamine as an Analgesic Adjuvant in Adult Trauma Intensive Care Unit Patients With Rib Fracture. Ann Pharmacother. 2018 Sep;52(9):849-854. doi: 10.1177/1060028018768451. Epub 2018 Apr 2.
PubMed 29607659
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Ketamine for Blunt Thoracic Trauma: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT06236113
- Acronym / sponsor ID
- 04/18/46
- Keywords
- Blunt Thoracic Trauma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- North Memorial Health CareUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 19 Mar 2023 (actual)
- Study completion
- 26 Jun 2023 (actual)
- First posted
- 1 Feb 2024 (actual)
- Results
- Posted 21 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this Randomized controlled double-blinded trial is to compare the addition of a ketamine infusion to placebo, when added to standard care in adult blunt trauma patients with multiple rib fractures. The main question it aims to answer are: • addition of low dose ketamine infusion (LDKI) decreases narcotic use • does LDKI impact pulmonary complications, readmission, or hospital length of stay Participants will receive usual standard of care with up to 48 hours of LDKI or placebo. If there is a comparison group: Researchers will compare infusion of a saline infusion to LDKI to see if LDKI decreases need for narcotic analgesics use.
Detailed description
Study Design: Randomized controlled double-blinded trial: Patients will then be randomized into one of two study groups. Both groups will receive a normal saline infusion for 48 hours of therapy. The treatment group will have ketamine added to their saline infusion via blinded pharmacy protocol to receive continuous infusion of ketamine at 0.1mg/kg/hour. The control group will receive only normal saline. Administration will occur via piggyback infusion in accordance with nursing policy.
Setting/Participants:
- North Memorial Health Hospital: patients on 5-South - Trauma Neuro Intensive Care Unit (TNICU) and 6-West - Trauma Floor
- 50 people will take part in this study. 25 study subjects will receive an infusion of ketamine and 25 will receive a saline infusion.
- Patients 18 years of age or older with 3 or more rib fractures admitted to North Memorial Health Hospital will be considered for the study.
Study Interventions and Measures:
- Ketamine low-dose infusion administered at 0.1 mg/kg/hr for 48 hours as an adjunct to standardized rib fracture management interventions as outlined in facility-approved Guidelines for Rib Fracture Management.
- The primary study outcome will be amount of narcotic used over the 48-hour study period (expressed as morphine mg equivalents).
- Secondary outcome measures will include: need for endotracheal intubation or non-invasive positive pressure ventilation, oxygen requirements, daily incentive spirometer values, daily forced vital capacity measurements, and subjective patient pain ratings.
- Other outcomes measured will be Intensive Care Unit stay, total hospital length of stay, and adverse medication effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- prospective, randomized, double-blinded, placebo-controlled study comparing saline infusion with low-dose ketamine versus saline infusion alone.
| Arm | Type | Receives |
|---|---|---|
| Placebo/Control | Placebo comparator | Drug: Ketamine 1 Mg/mL-NaCl 0.9% Intravenous SolutionPharmacist will check randomization schedule. For placebo/control subject they will prepare an infusion bag of saline with no added medication. The Study Drug Bag will be released with a label that includes: Name of Study, Study Subject #, Patient (Pt) Name, Pt Medical record number (MR#), Pt Date of birth (DOB), and INFUSION RATE. |
| Low Dose Ketamine Infusion (LDKI) | Experimental | Drug: Ketamine 1 Mg/mL-NaCl 0.9% Intravenous SolutionInfusion Bag will receive 100 mg of ketamine (Ketamine Infusion Subject). The Study Drug Bag will be released with a label that includes: Name of Study, Study Subject #, Patient Name, Pt MR#, Pt DOB, and INFUSION RATE. (Note: infusion rate is 0.1 mg/kg/hr and concentration of standard ketamine infusion bag is 1 mg/mL. That is, 100 mg of ketamine added to 100 mL saline). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males or females 18 years of age or older
- Diagnosis of 3 or more acute rib fractures related to blunt traumatic chest injury.
- Able to undergo consent procedure and give valid consent, or availability of family member to provide consent for the study
Key exclusion criteria (14 listed)
- Age <18 years
- Cognitively impaired
- Pregnant or lactating females.
- Glasgow Coma Score (GCS) of ≤ 14 at time of admission
- Evidence of increased intraocular pressure
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 1 Mg/mL-NaCl 0.9% Intravenous SolutionAlso: Low Dose Ketamine Infusion, Ketamine Dripadministered at rate of 0.1 mg/kg/hr | Drug | Low Dose Ketamine Infusion (LDKI), Placebo/Control |
Primary outcome
Milligrams of Morphine Equivalents (MME) Administered
Time frame: Outcome was evaluated up to a total of 96 hours (from time zero to 48 hours of infusion and up to 48 hrs after infusion stopped.
Standardized method of reporting narcotic analgesic administration by converting opioid narcotics to the equivalent dosage of morphine that would yield same result.
2 secondary outcomes
Pulmonary Complications
Time frame: Up to 30 days after intervention (administration of study drug)
ICU Admission or Hospital Readmission
Time frame: Up to 30 days after intervention (administration of study drug)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29607659Walters MK, Farhat J, Bischoff J, Foss M, Evans C. Ketamine as an Analgesic Adjuvant in Adult Trauma Intensive Care Unit Patients With Rib Fracture. Ann Pharmacother. 2018 Sep;52(9):849-854. doi: 10.1177/1060028018768451. Epub 2018 Apr 2.
- Individual participant dataSharing planned: No
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.
Michaela A West, MD, PhD study director
North Memorial Health
Joseph Farhat, MD principal investigator
North Memorial Health
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 testing Ketamine 1 Mg/mL-NaCl 0.9% Intravenous Solution in people with Blunt Injury of Thorax and Multiple Rib Fractures, Involving Three Ribs, run by North Memorial Health Care 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 14 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 May 2024. 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.
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 May 2024). 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?
Milligrams of Morphine Equivalents (MME) Administered (time frame: Outcome was evaluated up to a total of 96 hours (from time zero to 48 hours of infusion and up to 48 hrs after infusion stopped.). 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 NCT06236113, which also lists 1 linked publication.
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 May 2024; AzTrials last refreshed its copy on 30 Oct 2026.