Hip Fracture
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGIV Acetaminophen
The patient will receive 1,00mg IV Acetaminophen every 8 hours until 3 doses have been received post-operatively.
DRUGPO Acetaminophen
The patient will receive 1,000mg po Acetaminophen every 8 hours.
Sponsors
Corewell Health West
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Acute, isolated, unilateral femoral neck, intertrochanteric, and per trochanteric hip fractures confirmed by anteroposterior/lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI). 2. Age ≥ 65 years. 3. Low energy mechanism. 4. Hip fracture fixation performed within 48 hours of injury. 5. English speaking. 6. Anticipated medical optimization for operative fixation. 7. No other major trauma.
Exclusion criteria
1. Unable to provide informed consent (dementia, limited decision making capacity) 2. Admitted by medical service for significant co-morbidities 3. Retained hardware around the affected hip 4. Infection around the affected hip 5. Transfer patients with a length of stay \> 24 hours at the transferring hospital 6. Known allergy to acetaminophen 7. Current use of narcotics 8. Receiving a regional anesthetic block at any point during the hospitalization 9. Known history of hepatic disease (hepatitis, cirrhosis) 10. Weight \< 50kg 11. Prisoner 12. Involved in another clinical trial that would interfere with the intervention of this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score | 6 days | Pain scores will be compared between the two groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Amount of Morphine Equivalents, as Determined by an Opioid Dose Calculator, Received by the Patient. | 6 days | 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. |
| Timing of First Day of Ambulation. | 6 days | The timing of the first day of ambulation will be compared between the two groups. |
| Distance Ambulated | 6 days | The distance ambulated will be compared between the two groups. |
| Hospital Stay | 2 weeks | Length of hospital stay will be compared between the two groups. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PO Acetaminophen 1,000mg Acetaminophen po every 8 hours until discharge.
PO Acetaminophen: The patient will receive 1,000mg po Acetaminophen every 8 hours. | 0 |
| 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 |
| Total | 0 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Pain Score
Pain scores will be compared between the two groups.
Time frame: 6 days
Population: No analyses complete due to early termination.
Secondary
Distance Ambulated
The distance ambulated will be compared between the two groups.
Time frame: 6 days
Population: No analyses complete due to early termination.
Secondary
Hospital Stay
Length of hospital stay will be compared between the two groups.
Time frame: 2 weeks
Population: No analyses complete due to early termination.
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.
Time frame: 6 days
Population: No analyses complete due to early termination.
Secondary
Timing of First Day of Ambulation.
The timing of the first day of ambulation will be compared between the two groups.
Time frame: 6 days
Population: No analyses complete due to early termination.