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

Primary Purpose

Hip Fracture

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
IV Acetaminophen
PO Acetaminophen
Sponsored by
Spectrum Health Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fracture

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Spectrum Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

PO Acetaminophen

IV Acetaminophen

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Pain Score
Pain scores will be compared between the two groups.

Secondary Outcome Measures

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.
Timing of First Day of Ambulation.
The timing of the first day of ambulation will be compared between the two groups.
Distance Ambulated
The distance ambulated will be compared between the two groups.
Hospital Stay
Length of hospital stay will be compared between the two groups.

Full Information

First Posted
May 9, 2016
Last Updated
September 21, 2023
Sponsor
Spectrum Health Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT02774148
Brief Title
Pain Control in Elderly Hip Fracture Patients: Is Intravenous Acetaminophen Superior to Oral Administration?
Official Title
Pain Control in Elderly Hip Fracture Patients: Is Intravenous Acetaminophen Superior to Oral Administration?
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
Proved difficult to consent patient population due to comorbidities
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spectrum Health Hospitals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PO Acetaminophen
Arm Type
Active Comparator
Arm Description
1,000mg Acetaminophen po every 8 hours until discharge.
Arm Title
IV Acetaminophen
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
IV Acetaminophen
Other Intervention Name(s)
Ofirmev
Intervention Description
The patient will receive 1,00mg IV Acetaminophen every 8 hours until 3 doses have been received post-operatively.
Intervention Type
Drug
Intervention Name(s)
PO Acetaminophen
Other Intervention Name(s)
Tylenol
Intervention Description
The patient will receive 1,000mg po Acetaminophen every 8 hours.
Primary Outcome Measure Information:
Title
Pain Score
Description
Pain scores will be compared between the two groups.
Time Frame
6 days
Secondary Outcome Measure Information:
Title
The Amount of Morphine Equivalents, as Determined by an Opioid Dose Calculator, Received by the Patient.
Description
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
Title
Timing of First Day of Ambulation.
Description
The timing of the first day of ambulation will be compared between the two groups.
Time Frame
6 days
Title
Distance Ambulated
Description
The distance ambulated will be compared between the two groups.
Time Frame
6 days
Title
Hospital Stay
Description
Length of hospital stay will be compared between the two groups.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew R. Fras, MD
Organizational Affiliation
Spectrum Health Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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