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Proved difficult to consent patient population due to comorbidities
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The primary objective is to determine if intravenous acetaminophen decreases pain scores and the amount of morphine equivalence received as compared to oral acetaminophen in patients greater than 65 years old after sustaining a hip fracture.
Surgeons involved in this research agree to the randomization of patients into one of two groups. After informed consent, patients will be randomly assigned in a 1:1 ratio to the treatment group or the control group.
Group 1: This group will serve as the control group, and will be scheduled to receive one gram (1g) acetaminophen PO every 8 hours.
Group 2: This group will serve as the treatment group, and will be scheduled to receive one gram (1g) acetaminophen IV every 8 hours
The standardized pain control protocol for hip fracture patients will be initiated for all patients. The pain protocol will be initiated at hospital admission, and after three postoperative doses of the group assigned acetaminophen all patients will be switched to one gram scheduled acetaminophen PO in preparation for hospital discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PO Acetaminophen | Active Comparator | 1,000mg Acetaminophen po every 8 hours until discharge. |
|
| IV Acetaminophen | Experimental | 1,000mg Acetaminophen IV every 8 hours until the patient has received 3 doses post-operatively. Then 1,000mg Acetaminophen po every 8 hours until discharge. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV Acetaminophen | Drug | The patient will receive 1,00mg IV Acetaminophen every 8 hours until 3 doses have been received post-operatively. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score | Pain scores will be compared between the two groups. | 6 days |
| Measure | Description | Time Frame |
|---|---|---|
| The Amount of Morphine Equivalents, as Determined by an Opioid Dose Calculator, Received by the Patient. | The amount of opioid pain medication a patient receives will be recorded and the Morphine equivalents will be determined by an opioid dose calculator. The morphine equivalents will be compared between the two groups. | 6 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew R. Fras, MD | Corewell Health West | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spectrum Health | Grand Rapids | Michigan | 49503 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | PO Acetaminophen | 1,000mg Acetaminophen po every 8 hours until discharge. PO Acetaminophen: The patient will receive 1,000mg po Acetaminophen every 8 hours. |
| FG001 | IV Acetaminophen | 1,000mg Acetaminophen IV every 8 hours until the patient has received 3 doses post-operatively. Then 1,000mg Acetaminophen po every 8 hours until discharge. IV Acetaminophen: The patient will receive 1,00mg IV Acetaminophen every 8 hours until 3 doses have been received post-operatively. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Only one patient was enrolled, therefore data was not sufficient to run an analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | PO Acetaminophen | 1,000mg Acetaminophen po every 8 hours until discharge. PO Acetaminophen: The patient will receive 1,000mg po Acetaminophen every 8 hours. |
| BG001 | IV Acetaminophen |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| 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 | Pain Score | Pain scores will be compared between the two groups. | No analyses complete due to early termination. | Posted | 6 days |
|
3 days
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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 | PO Acetaminophen | 1,000mg Acetaminophen po every 8 hours until discharge. PO Acetaminophen: The patient will receive 1,000mg po Acetaminophen every 8 hours. |
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Early termination due to difficulty enrolling patient population and limitations due to timing required to consent.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrea Mantel | Spectrum Health | 616-486-2051 | andrea.mantel@spectrumhealth.org |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| PO Acetaminophen | Drug | The patient will receive 1,000mg po Acetaminophen every 8 hours. |
|
|
| Timing of First Day of Ambulation. |
The timing of the first day of ambulation will be compared between the two groups. |
| 6 days |
| Distance Ambulated | The distance ambulated will be compared between the two groups. | 6 days |
| Hospital Stay | Length of hospital stay will be compared between the two groups. | 2 weeks |
1,000mg Acetaminophen IV every 8 hours until the patient has received 3 doses post-operatively. Then 1,000mg Acetaminophen po every 8 hours until discharge.
IV Acetaminophen: The patient will receive 1,00mg IV Acetaminophen every 8 hours until 3 doses have been received post-operatively.
| BG002 | Total | Total of all reporting groups |
|
| Sex: Female, Male |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. |
|
| Secondary | The Amount of Morphine Equivalents, as Determined by an Opioid Dose Calculator, Received by the Patient. | The amount of opioid pain medication a patient receives will be recorded and the Morphine equivalents will be determined by an opioid dose calculator. The morphine equivalents will be compared between the two groups. | No analyses complete due to early termination. | Posted | 6 days |
|
|
| Secondary | Timing of First Day of Ambulation. | The timing of the first day of ambulation will be compared between the two groups. | No analyses complete due to early termination. | Posted | 6 days |
|
|
| Secondary | Distance Ambulated | The distance ambulated will be compared between the two groups. | No analyses complete due to early termination. | Posted | 6 days |
|
|
| Secondary | Hospital Stay | Length of hospital stay will be compared between the two groups. | No analyses complete due to early termination. | Posted | 2 weeks |
|
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| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | IV Acetaminophen | 1,000mg Acetaminophen IV every 8 hours until the patient has received 3 doses post-operatively. Then 1,000mg Acetaminophen po every 8 hours until discharge. IV Acetaminophen: The patient will receive 1,00mg IV Acetaminophen every 8 hours until 3 doses have been received post-operatively. | 0 | 0 | 0 | 0 |
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| D007869 |
| Leg Injuries |
| Aniline Compounds |
| D000588 | Amines |