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

NCT ID: NCT02774148

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2016-12-31

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.

Conditions

Hip Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PO Acetaminophen

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

Group Type: ACTIVE_COMPARATOR

PO Acetaminophen

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

IV Acetaminophen

Intervention Type: DRUG

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

Interventions

IV Acetaminophen

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

Intervention Type: DRUG

PO Acetaminophen

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

Intervention Type: DRUG

Other Intervention Names

Ofirmev; Tylenol

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spectrum Health Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew R. Fras, MD

Role: PRINCIPAL_INVESTIGATOR

Spectrum Health Hospitals

Locations

Spectrum Health

Grand Rapids, Michigan, United States

Countries

United States

Other Identifiers

2016-225

Identifier Type: -

Identifier Source: org_study_id