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

NCT02774148 | Terminated Phase 4 Results

• 1 other identifier: 2016-225
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Fracture

Outcome Measures

Primary Outcomes (1)

• Pain Score

  Pain scores will be compared between the two groups.

  6 days

Secondary Outcomes (4)

• The Amount of Morphine Equivalents, as Determined by an Opioid Dose Calculator, Received by the Patient.

  6 days

• Timing of First Day of Ambulation.

  6 days

• Distance Ambulated

  6 days

• Hospital Stay

  2 weeks

Study Arms (2)

PO Acetaminophen

ACTIVE COMPARATOR

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

Drug: PO Acetaminophen

IV Acetaminophen

EXPERIMENTAL

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.

Drug: IV Acetaminophen

Interventions

IV Acetaminophen DRUG

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

Also known as: Ofirmev

IV Acetaminophen

PO Acetaminophen DRUG

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

Also known as: Tylenol

PO Acetaminophen

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Acute, isolated, unilateral femoral neck, intertrochanteric, and per trochanteric hip fractures confirmed by anteroposterior/lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI).
• Age ≥ 65 years.
• Low energy mechanism.
• Hip fracture fixation performed within 48 hours of injury.
• English speaking.
• Anticipated medical optimization for operative fixation.
• No other major trauma.

You may not qualify if:

• Unable to provide informed consent (dementia, limited decision making capacity)
• Admitted by medical service for significant co-morbidities
• Retained hardware around the affected hip
• Infection around the affected hip
• Transfer patients with a length of stay \> 24 hours at the transferring hospital
• Known allergy to acetaminophen
• Current use of narcotics
• Receiving a regional anesthetic block at any point during the hospitalization
• Known history of hepatic disease (hepatitis, cirrhosis)
• Weight \< 50kg
• Prisoner
• Involved in another clinical trial that would interfere with the intervention of this study

Sponsors & Collaborators

• Corewell Health West: lead

Study Sites (1)

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

MeSH Terms

Conditions

Hip Fractures

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

Early termination due to difficulty enrolling patient population and limitations due to timing required to consent.

Results Point of Contact

• Title: Andrea Mantel
• Organization: Spectrum Health

andrea.mantel@spectrumhealth.org

616-486-2051

Study Officials

• Andrew R. Fras, MD

  Corewell Health West

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: May 17, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 28, 2023
• Results First Posted: February 7, 2018

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)