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Pain Control in Elderly Hip Fracture Patients: Is Intravenous Acetaminophen Superior to Oral Administration?

Phase 4
Terminated
Conditions
Hip Fracture
Interventions
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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PO AcetaminophenPO Acetaminophen1,000mg Acetaminophen po every 8 hours until discharge.
IV AcetaminophenIV Acetaminophen1,000mg 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
NameTimeMethod
Pain Score6 days

Pain scores will be compared between the two groups.

Secondary Outcome Measures
NameTimeMethod
Timing of First Day of Ambulation.6 days

The timing of the first day of ambulation will be compared between the two groups.

Distance Ambulated6 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 Stay2 weeks

Length of hospital stay will be compared between the two groups.

Trial Locations

Locations (1)

Spectrum Health

🇺🇸

Grand Rapids, Michigan, United States

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