A Phase 4 interventional study of Ketamine 1 Mg/mL-NaCl 0.9% Intravenous Solution in Blunt Injury of Thorax and Multiple Rib Fractures, Involving Three Ribs, sponsored by North Memorial Health Care. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-21.
Sponsored by North Memorial Health Care · Phase 4, Interventional, and Treatment
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.
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:
Study Interventions and Measures:
131 studies on the registry are indexed under Rib Fractures; 27 are open to participants now.
This study's enrollment of 50 is below the median of 60 across 99 interventional studies indexed under Rib Fractures.
Browse Rib Fractures studies →This is the only study on the registry with North Memorial Health Care as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Ketamine 1 Mg/mL-NaCl 0.9% Intravenous Solution
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).
Drug: Ketamine 1 Mg/mL-NaCl 0.9% Intravenous Solution
administered at rate of 0.1 mg/kg/hr
Also known as: Low Dose Ketamine Infusion, Ketamine Drip
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.
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.
Pulmonary Complications
Number of participants that develop pneumonia, require intubation, or non-invasive positive pressure ventilation
Time frame: 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.
Time frame: Up to 30 days after intervention (administration of study drug)
| Milestone | Placebo/Control | Low Dose Ketamine Infusion (LDKI) |
|---|---|---|
| Started | 25 | 25 |
| Completed | 25 | 25 |
| Not completed | 0 | 0 |
Standardized method of reporting narcotic analgesic administration by converting opioid narcotics to the equivalent dosage of morphine that would yield same result.
| Morphine Milligam Equivalents (MME) | Placebo/Control | Low Dose Ketamine Infusion (LDKI) |
|---|---|---|
| Milligrams of Morphine Equivalents (MME) Administered | 84.9 ± 31.9 | 81.7 ± 32.4 |
Number of participants that develop pneumonia, require intubation, or non-invasive positive pressure ventilation
| Participants | Placebo/Control | Low Dose Ketamine Infusion (LDKI) |
|---|---|---|
| Develop pneumonia | 3 | 0 |
| Require non-invasive positive pressure ventilation | 8 | 9 |
| Require intubation | 1 | 1 |
| No pulmonary complications | 13 | 14 |
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.
| Participants | Placebo/Control | Low Dose Ketamine Infusion (LDKI) |
|---|---|---|
| ICU Readmission within 30 days | 2 | 0 |
| Hospital Readmission within 30 days | 3 | 1 |
| No need for hospital or ICU readmission | 20 | 23 |
Collected over Adverse events data were specifically analyzed for a time period within 30 days of initiation of study drug infusion.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo/Control | 0/25 (0%) | 1/25 (4%) | 11/25 (44%) |
| Low Dose Ketamine Infusion (LDKI) | 0/25 (0%) | 1/25 (4%) | 9/25 (36%) |
| Event | Placebo/Control | Low Dose Ketamine Infusion (LDKI) |
|---|---|---|
| Acute Respiratory failureRespiratory, thoracic and mediastinal disorders | 1/25 | 1/25 |
| Event | Placebo/Control | Low Dose Ketamine Infusion (LDKI) |
|---|---|---|
| Non-serious adverse eventsRespiratory, thoracic and mediastinal disorders | 11/25 | 9/25 |
Adult trauma in-patients with three or more rib fractures. Inclusion criteria were: age \>18 years, known blunt chest trauma with \>three rib fractures, and able to provide informed consent.
| Age, Categorical(Participants) | Placebo/Control | Low Dose Ketamine Infusion (LDKI) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 13 | 17 | 30 |
| >=65 years | 12 | 8 | 20 |
| Age, Continuous(years) | Placebo/Control | Low Dose Ketamine Infusion (LDKI) | Total |
|---|---|---|---|
| Mean | 64.8 ± 11.2 | 57.6 ± 14.8 | 62.8 ± 13.5 |
| Sex: Female, Male(Participants) | Placebo/Control | Low Dose Ketamine Infusion (LDKI) | Total |
|---|---|---|---|
| Female | 8 | 5 | 13 |
| Male | 17 | 20 | 37 |
| Race and Ethnicity Not Collected(Participants) | Placebo/Control | Low Dose Ketamine Infusion (LDKI) | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Placebo/Control | Low Dose Ketamine Infusion (LDKI) | Total |
|---|---|---|---|
| United States | 25 | 25 | 50 |
| Average number fractured ribs(Number of fractured ribs) | Placebo/Control | Low Dose Ketamine Infusion (LDKI) | Total |
|---|---|---|---|
| Mean | 5.7 ± 1.9 | 7.1 ± 3.8 | 6.3 ± 3.0 |
| Injury Severity Score (ISS)(Units on a scale) | Placebo/Control | Low Dose Ketamine Infusion (LDKI) | Total |
|---|---|---|---|
| Mean | 11.4 ± 3.2 | 15.1 ± 5.1 | 13.0 ± 4.5 |
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