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Withdrawals from study due to anticipated effects from study drugs
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This study will compare ketamine and hydromorphone as alternative patient-controlled interventions for trauma-related pain. Patients receiving ketamine PCA are expected to require less total and breakthrough opioid and to have similar or improved objective pain scores. Patients receiving ketamine are also expected to have shorter duration of supplemental oxygen requirement, fewer episodes of oxygen desaturation, improved pulmonary toilet, lower use of antiemetics, and shorter times to first bowel movement. Ketamine is further expected to be associated with decreased intensive care unit and hospital lengths of stay, faster time to maximum allowable ambulation, decreased opioid dosage at discharge, and lower report of chronic pain syndromes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine | Experimental | Ketamine 90mg/30 mL PCA (3 mg/mL) |
|
| Hydromorphone | Active Comparator | Hydromorphone 6mg/30 mL PCA (0.2 mg/mL) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | Ketamine administered as patient-controlled analgesia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Daily Opioid Requirement | Daily breakthrough opioid requirement plus non-breakthrough opioid use in milligrams of morphine equivalents | Participants will be followed for their entire hospital stay, an expected average of 1 week. |
| Measure | Description | Time Frame |
|---|---|---|
| Breakthrough Daily Opioid Requirement | Breakthrough daily opioid requirement in milligrams of morphine equivalents/day | Participants will be followed for their entire hospital stay, an expected average of 1 week |
| Median Pain Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sheila C Takieddine, Pharm.D. | UC Health | Principal Investigator |
| Eric W Mueller, Pharm.D. | UC Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29605036 | Derived | Takieddine SC, Droege CA, Ernst N, Droege ME, Webb M, Branson RD, Gerlach TW, Robinson BRH, Johannigman JA, Mueller EW. Ketamine versus hydromorphone patient-controlled analgesia for acute pain in trauma patients. J Surg Res. 2018 May;225:6-14. doi: 10.1016/j.jss.2017.12.019. Epub 2018 Jan 8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ketamine | Ketamine 90mg/30 mL PCA (3 mg/mL) Ketamine: Ketamine administered as patient-controlled analgesia. |
| FG001 | Hydromorphone | Hydromorphone 6mg/30 mL PCA (0.2 mg/mL) Hydromorphone: Hydromorphone administered as patient-controlled analgesia. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ketamine | Ketamine 90mg/30 mL PCA (3 mg/mL) Ketamine: Ketamine administered as patient-controlled analgesia. |
| BG001 | Hydromorphone | Hydromorphone 6mg/30 mL PCA (0.2 mg/mL) Hydromorphone: Hydromorphone administered as patient-controlled analgesia. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Daily Opioid Requirement | Daily breakthrough opioid requirement plus non-breakthrough opioid use in milligrams of morphine equivalents | Posted | Median | Inter-Quartile Range | mg morphine equivalents/day | Participants will be followed for their entire hospital stay, an expected average of 1 week. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ketamine | Ketamine 90mg/30 mL PCA (3 mg/mL) Ketamine: Ketamine administered as patient-controlled analgesia. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hallucinations | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sheila Takieddine | UC Health University of Cincinnati Medical Center | 513-585-6195 | Sheila.Takieddine@UCHealth.com |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D009104 | Multiple Trauma |
| D050723 | Fractures, Bone |
| D010146 | Pain |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D004091 | Hydromorphone |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Hydromorphone | Drug | Hydromorphone administered as patient-controlled analgesia. |
|
|
Median daily pain score measures on a visual analogue scale for pain, with a range of 0 to 10. Higher scored indicate worse pain.
| Participants will be followed for their entire hospital stay, an expected average of 1 week |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| BMI | Median | Inter-Quartile Range | kg/m^2 |
|
| Injury Severity Score | The Injury Severity Score is an anatomical scoring system that correlates with morbidity and mortality. The value can range from 0 to 75. Higher values represent a worse outcome. Reference: Baker SP et al, "The Injury Severity Score: a method for describing patients with multiple injuries and evaluating emergency care", J Trauma 14:187-196;1974. | Median | Inter-Quartile Range | scores on a scale |
|
| Blunt Trauma | Count of Participants | Participants |
|
| Penetrating Trauma | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Breakthrough Daily Opioid Requirement | Breakthrough daily opioid requirement in milligrams of morphine equivalents/day | Posted | Median | Inter-Quartile Range | mg morphine equivalents/day | Participants will be followed for their entire hospital stay, an expected average of 1 week |
|
|
|
| Secondary | Median Pain Score | Median daily pain score measures on a visual analogue scale for pain, with a range of 0 to 10. Higher scored indicate worse pain. | Posted | Median | Inter-Quartile Range | scores on a scale | Participants will be followed for their entire hospital stay, an expected average of 1 week |
|
|
|
| 0 |
| 10 |
| 7 |
| 10 |
| EG001 | Hydromorphone | Hydromorphone 6mg/30 mL PCA (0.2 mg/mL) Hydromorphone: Hydromorphone administered as patient-controlled analgesia. | 0 | 10 | 5 | 10 |
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |