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

Phase 4TerminatedNCT02774148

Corewell Health West1 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hip Fracture

Interventions

IV AcetaminophenDRUG

The patient will receive 1,00mg IV Acetaminophen every 8 hours until 3 doses have been received post-operatively.

PO AcetaminophenDRUG

The patient will receive 1,000mg po Acetaminophen every 8 hours.

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Spectrum Health

Grand Rapids, Michigan, United States

Outcomes

Primary Outcomes

Pain Score

Pain scores will be compared between the two groups.

Time frame: 6 days

Secondary Outcomes

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

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

Distance Ambulated

The distance ambulated will be compared between the two groups.

Time frame: 6 days

Hospital Stay

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

Time frame: 2 weeks

Data from ClinicalTrials.gov

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