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Intravenous vs Oral Acetaminophen in Postoperative Hip Fracture Adult Patients (INTACT-HIP)

Primary Purpose

Hip-fracture, Surgery

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Intravenous (IV) acetaminophen + oral placebo
Intravenous (IV) placebo plus oral acetaminophen
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip-fracture focused on measuring elderly, acetaminophen, oral vs intravenous, hip fracture surgery

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 60 years of age and older
  • Patients who were ambulating without human assistance before fracture, with any type of non-neoplastic hip fracture
  • Patients undergoing surgical treatment as an inpatient

Exclusion Criteria:

  • Patients with neoplastic hip fracture
  • Severe cognitive impairment (Montreal Cognitive Assessment (MoCA) <10)
  • Pre-existing delirium
  • Known hypersensitivity or allergy to acetaminophen
  • Severe or chronic liver or kidney dysfunction
  • Planned postoperative ventilation
  • Swallowing issues and/or dysphagia
  • English language limitation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intravenous (IV) acetaminophen plus oral placebo

    Intravenous (IV) placebo plus oral acetaminophen

    Arm Description

    In this group, the IV study drug will be IV acetaminophen and the oral study drug will be a placebo tablet.

    In this group the IV study drug will be normal saline and the pill will be acetaminophen

    Outcomes

    Primary Outcome Measures

    Trial feasibility-Recruitment
    Feasibility as assessed by recruitment rate. This will be assesses as proportion of patients enrolled in the study compared to the number of patients meeting the inclusion/exclusion criteria.
    Trial feasibility-Attrition
    Feasibility as assessed by attrition rates. This will be defined as the proportion of patients completing the study at follow-up compared to the enrolled patients.
    Trial feasibility-Availability of human resources
    Feasibility as assessed by lack of availability of human resources). Inability to include patient in study due to lack of pharmacist or research assistant availability will be documented.
    Trial feasibility-Comply study procedures
    Feasibility as assessed by failure to comply with study procedures. Failure to provide study drug at scheduled time will be documented.
    Trial safety
    Safety will be assessed as the number of participants experiencing intervention-related adverse or serious adverse events.

    Secondary Outcome Measures

    Postoperative pain
    Pain will be assessed using the visual analogue (VAS) scale (0-10) at rest and movement, with 0=no pain and 10=worst pain possible
    Opioid consumption
    Oral morphine equivalents (OMEQS) in milligrams
    Delirium
    Delirium incidence will be measured using the Confusion assessment method (CAM)-Long Form
    Cognitive dysfunction
    Cognitive dysfunction will be assessed using the Montreal Cognitive Assessment (MoCA)
    Overall health and disability
    Overall health and disability will be measured using the WHO Disability Assessment Schedule, version 2.0 (WHODAS 2.0), a 12-item validated measure that assesses cognition, mobility, self-care, interpersonal relationships, work and household roles, and participation in society
    Depression screen
    Patient Health Questionnaire (PHQ)-2 a 2-question questionnaire will be used as a validated measure to screen for depression.
    Ambulation
    Ambulation will be assessed as the ability to walk 10 feet or across a room without human assistance
    Post-operative adverse events
    Post-operative adverse events will be obtained from the study institution's National Surgical Quality Improvement Project (NSQIP) database as as death, ICU admission, standardized cardiac, respiratory and neurological postoperative events, and readmission to hospital.
    Discharge location
    Location of discharge after surgery

    Full Information

    First Posted
    May 16, 2022
    Last Updated
    October 31, 2022
    Sponsor
    University Health Network, Toronto
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05425355
    Brief Title
    Intravenous vs Oral Acetaminophen in Postoperative Hip Fracture Adult Patients
    Acronym
    INTACT-HIP
    Official Title
    INTACT-HIP: INTravenous Acetaminophen vs. Oral Randomized Controlled Trial in HIP Fracture Patients - a Feasibility Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 4, 2022 (Anticipated)
    Primary Completion Date
    March 1, 2024 (Anticipated)
    Study Completion Date
    June 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Health Network, Toronto

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The INTACT-HIP trial study will evaluate feasibility of conducting a randomized, double-blinded controlled trial comparing postoperative treatment with intravenous (IV) acetaminophen versus oral acetaminophen, in older adults undergoing hip fracture surgery. The results of this feasibility trial will be used to inform designing a larger, multi-center, randomized controlled trial to assess the efficacy of IV acetaminophen compared to oral acetaminophen to reduce delirium and improve other clinical and patient-centered outcomes after hip fracture surgery. It will randomize 42 older adults to receive either oral or IV acetaminophen after hip fracture surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hip-fracture, Surgery
    Keywords
    elderly, acetaminophen, oral vs intravenous, hip fracture surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    The study intervention will start after the surgery for the hip fracture with administration of the study drugs, starting in the post-anesthesia care unit (PACU). All patients will receive both a tablet and an IV solution every 6 hours for 48 hours, for a total of 8 doses. In the intravenous (IV) group, the IV study drug will be IV acetaminophen and the oral study drug will be a placebo tablet; vice versa, in the per oral (PO) group, the IV study drug will be normal saline and the pill will be acetaminophen. After 48 hours, all the patients will receive oral acetaminophen every 6 hours as per usual practice
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    42 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intravenous (IV) acetaminophen plus oral placebo
    Arm Type
    Experimental
    Arm Description
    In this group, the IV study drug will be IV acetaminophen and the oral study drug will be a placebo tablet.
    Arm Title
    Intravenous (IV) placebo plus oral acetaminophen
    Arm Type
    Active Comparator
    Arm Description
    In this group the IV study drug will be normal saline and the pill will be acetaminophen
    Intervention Type
    Drug
    Intervention Name(s)
    Intravenous (IV) acetaminophen + oral placebo
    Intervention Description
    Postoperatively patients will receive both a tablet and an IV solution every 6 hours for 48 hours, for a total of 8 doses. In this group, the IV study drug will be IV acetaminophen and the oral study drug will be a placebo tablet.
    Intervention Type
    Drug
    Intervention Name(s)
    Intravenous (IV) placebo plus oral acetaminophen
    Intervention Description
    Postoperatively patients will receive both a tablet and an IV solution every 6 hours for 48 hours, for a total of 8 doses. In this group the IV study drug will be normal saline and the pill will be acetaminophen
    Primary Outcome Measure Information:
    Title
    Trial feasibility-Recruitment
    Description
    Feasibility as assessed by recruitment rate. This will be assesses as proportion of patients enrolled in the study compared to the number of patients meeting the inclusion/exclusion criteria.
    Time Frame
    30 days
    Title
    Trial feasibility-Attrition
    Description
    Feasibility as assessed by attrition rates. This will be defined as the proportion of patients completing the study at follow-up compared to the enrolled patients.
    Time Frame
    30 days
    Title
    Trial feasibility-Availability of human resources
    Description
    Feasibility as assessed by lack of availability of human resources). Inability to include patient in study due to lack of pharmacist or research assistant availability will be documented.
    Time Frame
    30 days
    Title
    Trial feasibility-Comply study procedures
    Description
    Feasibility as assessed by failure to comply with study procedures. Failure to provide study drug at scheduled time will be documented.
    Time Frame
    30 days
    Title
    Trial safety
    Description
    Safety will be assessed as the number of participants experiencing intervention-related adverse or serious adverse events.
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    Postoperative pain
    Description
    Pain will be assessed using the visual analogue (VAS) scale (0-10) at rest and movement, with 0=no pain and 10=worst pain possible
    Time Frame
    Before surgery, on day of surgery, and days 1,2,3 after surgery
    Title
    Opioid consumption
    Description
    Oral morphine equivalents (OMEQS) in milligrams
    Time Frame
    Before surgery, on day of surgery, and days 1,2,3 after surgery
    Title
    Delirium
    Description
    Delirium incidence will be measured using the Confusion assessment method (CAM)-Long Form
    Time Frame
    On day of surgery, and days 1,2, 3 after surgery
    Title
    Cognitive dysfunction
    Description
    Cognitive dysfunction will be assessed using the Montreal Cognitive Assessment (MoCA)
    Time Frame
    Before surgery and day 3 after surgery (or at discharge time if hospital stay less than 3 days after surgery)
    Title
    Overall health and disability
    Description
    Overall health and disability will be measured using the WHO Disability Assessment Schedule, version 2.0 (WHODAS 2.0), a 12-item validated measure that assesses cognition, mobility, self-care, interpersonal relationships, work and household roles, and participation in society
    Time Frame
    Baseline and at 30 days after surgery
    Title
    Depression screen
    Description
    Patient Health Questionnaire (PHQ)-2 a 2-question questionnaire will be used as a validated measure to screen for depression.
    Time Frame
    Before surgery and day 3 after surgery (or at discharge time if hospital stay less than 3 days after surgery)
    Title
    Ambulation
    Description
    Ambulation will be assessed as the ability to walk 10 feet or across a room without human assistance
    Time Frame
    Before surgery and day 3 after surgery (or at discharge time if hospital stay less than 3 days after surgery)
    Title
    Post-operative adverse events
    Description
    Post-operative adverse events will be obtained from the study institution's National Surgical Quality Improvement Project (NSQIP) database as as death, ICU admission, standardized cardiac, respiratory and neurological postoperative events, and readmission to hospital.
    Time Frame
    On day of surgery, days 1,2, 3 after surgery, and at 30 days after surgery
    Title
    Discharge location
    Description
    Location of discharge after surgery
    Time Frame
    At the time of discharge (at 1-3 days after surgery in most cases)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 60 years of age and older Patients who were ambulating without human assistance before fracture, with any type of non-neoplastic hip fracture Patients undergoing surgical treatment as an inpatient Exclusion Criteria: Patients with neoplastic hip fracture Severe cognitive impairment (Montreal Cognitive Assessment (MoCA) <10) Pre-existing delirium Known hypersensitivity or allergy to acetaminophen Severe or chronic liver or kidney dysfunction Planned postoperative ventilation Swallowing issues and/or dysphagia English language limitation
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nayeemur Rahman
    Phone
    416-603-5800
    Ext
    3959
    Email
    Nayeemur.Rahman@uhnresearch.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kawal P Singh
    Phone
    416-603-5800
    Ext
    3959
    Email
    kawalpreet.singh@uhnresearcj.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jean Wong, MD
    Organizational Affiliation
    University Health Network, Toronto
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    22354127
    Citation
    Jahr JS, Breitmeyer JB, Pan C, Royal MA, Ang RY. Safety and efficacy of intravenous acetaminophen in the elderly after major orthopedic surgery: subset data analysis from 3, randomized, placebo-controlled trials. Am J Ther. 2012 Mar;19(2):66-75. doi: 10.1097/MJT.0b013e3182456810.
    Results Reference
    result
    PubMed Identifier
    31804347
    Citation
    Chen DX, Yang L, Ding L, Li SY, Qi YN, Li Q. Perioperative outcomes in geriatric patients undergoing hip fracture surgery with different anesthesia techniques: A systematic review and meta-analysis. Medicine (Baltimore). 2019 Dec;98(49):e18220. doi: 10.1097/MD.0000000000018220.
    Results Reference
    result
    PubMed Identifier
    31100691
    Citation
    Harris MJ, Brovman EY, Urman RD. Clinical predictors of postoperative delirium, functional status, and mortality in geriatric patients undergoing non-elective surgery for hip fracture. J Clin Anesth. 2019 Dec;58:61-71. doi: 10.1016/j.jclinane.2019.05.010. Epub 2019 May 14.
    Results Reference
    result

    Learn more about this trial

    Intravenous vs Oral Acetaminophen in Postoperative Hip Fracture Adult Patients

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