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

Spectrum Health Hospitals

Status and phase: Terminated; Phase 4

Conditions: Hip Fracture

Treatments: Drug: PO Acetaminophen; Drug: IV Acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT02774148

2016-225

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

PO Acetaminophen

Active Comparator group

Description:

1,000mg Acetaminophen po every 8 hours until discharge.

Treatment:

Drug: PO Acetaminophen

IV Acetaminophen

Experimental group

Description:

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.

Treatment:

Drug: IV Acetaminophen