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
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
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
NCT ID
NCT05425355
First Posted
May 16, 2022
Last Updated
October 31, 2022
Sponsor
University Health Network, Toronto
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
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Intravenous vs Oral Acetaminophen in Postoperative Hip Fracture Adult Patients
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