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

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ClinicalTrials.gov Identifier: NCT02774148
Recruitment Status : Terminated (Proved difficult to consent patient population due to comorbidities)
First Posted : May 17, 2016
Results First Posted : February 7, 2018
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Spectrum Health Hospitals

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.

Condition or disease Intervention/treatment Phase
Hip Fracture Drug: IV Acetaminophen Drug: PO Acetaminophen Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pain Control in Elderly Hip Fracture Patients: Is Intravenous Acetaminophen Superior to Oral Administration?
Study Start Date : December 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Ofirmev




Primary Outcome Measures :
  1. Pain Score [ Time Frame: 6 days ]
    Pain scores will be compared between the two groups.


Secondary Outcome Measures :
  1. The Amount of Morphine Equivalents, as Determined by an Opioid Dose Calculator, Received by the Patient. [ Time Frame: 6 days ]
    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.

  2. Timing of First Day of Ambulation. [ Time Frame: 6 days ]
    The timing of the first day of ambulation will be compared between the two groups.

  3. Distance Ambulated [ Time Frame: 6 days ]
    The distance ambulated will be compared between the two groups.

  4. Hospital Stay [ Time Frame: 2 weeks ]
    Length of hospital stay will be compared between the two groups.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02774148


Locations
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United States, Michigan
Spectrum Health
Grand Rapids, Michigan, United States, 49503
Sponsors and Collaborators
Spectrum Health Hospitals
Investigators
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Principal Investigator: Andrew R. Fras, MD Spectrum Health Hospitals

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Responsible Party: Spectrum Health Hospitals
ClinicalTrials.gov Identifier: NCT02774148     History of Changes
Other Study ID Numbers: 2016-225
First Posted: May 17, 2016    Key Record Dates
Results First Posted: February 7, 2018
Last Update Posted: February 7, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Acetaminophen
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics