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

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.

Study Overview

• Status: Terminated
• Conditions: Hip Fracture
• Intervention / Treatment: Drug: PO Acetaminophen; Drug: IV Acetaminophen

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PO Acetaminophen; 1,000mg Acetaminophen po every 8 hours until discharge.	Drug: PO Acetaminophen; The patient will receive 1,000mg po Acetaminophen every 8 hours.; Other Names: Tylenol
Experimental: 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.	Drug: IV Acetaminophen; The patient will receive 1,00mg IV Acetaminophen every 8 hours until 3 doses have been received post-operatively.; Other Names: Ofirmev

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score	Pain scores will be compared between the two groups.	6 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 days
Timing of First Day of Ambulation.	The timing of the first day of ambulation will be compared between the two groups.	6 days
Distance Ambulated	The distance ambulated will be compared between the two groups.	6 days
Hospital Stay	Length of hospital stay will be compared between the two groups.	2 weeks

Collaborators and Investigators

• Sponsor: Spectrum Health Hospitals
• Investigators: Principal Investigator: Andrew R. Fras, MD, Spectrum Health Hospitals

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: May 9, 2016
• First Submitted That Met QC Criteria: May 16, 2016
• First Posted (Estimated): May 17, 2016

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: 2016-225

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO