Pain Control in Elderly Hip Fracture Patients: Is Intravenous Acetaminophen Superior to Oral Administration?
- Registration Number
- NCT02774148
- Lead Sponsor
- Spectrum Health Hospitals
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 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).
- Age ≥ 65 years.
- Low energy mechanism.
- Hip fracture fixation performed within 48 hours of injury.
- English speaking.
- Anticipated medical optimization for operative fixation.
- No other major trauma.
- Unable to provide informed consent (dementia, limited decision making capacity)
- Admitted by medical service for significant co-morbidities
- Retained hardware around the affected hip
- Infection around the affected hip
- Transfer patients with a length of stay > 24 hours at the transferring hospital
- Known allergy to acetaminophen
- Current use of narcotics
- Receiving a regional anesthetic block at any point during the hospitalization
- Known history of hepatic disease (hepatitis, cirrhosis)
- Weight < 50kg
- Prisoner
- Involved in another clinical trial that would interfere with the intervention of this study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PO Acetaminophen PO Acetaminophen 1,000mg Acetaminophen po every 8 hours until discharge. IV Acetaminophen 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.
- Primary Outcome Measures
Name Time Method Pain Score 6 days Pain scores will be compared between the two groups.
- Secondary Outcome Measures
Name Time Method 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.
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.
Hospital Stay 2 weeks Length of hospital stay will be compared between the two groups.
Trial Locations
- Locations (1)
Spectrum Health
🇺🇸Grand Rapids, Michigan, United States