Clinical trial NCT02774148: Pain Control in Elderly Hip Fracture Patients: Is Intravenous Acetaminophen Superior to Oral Administration?
Official title: Pain Control in Elderly Hip Fracture Patients: Is Intravenous Acetaminophen Superior to Oral Administration?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hip Fracture
Lead sponsor: Spectrum Health Hospitals
Sponsor class: OTHER
First posted: 2016-05-17
Enrollment: 1
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Score
timeFrame: 6 days
Secondary outcomes:
measure: The Amount of Morphine Equivalents, as Determined by an Opioid Dose Calculator, Received by the Patient.
timeFrame: 6 days
measure: Timing of First Day of Ambulation.
timeFrame: 6 days
measure: Distance Ambulated
timeFrame: 6 days
measure: Hospital Stay
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
Study officials:
affiliation: Spectrum Health Hospitals
name: Andrew R. Fras, MD
role: PRINCIPAL_INVESTIGATOR
References: