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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
42
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.
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
Toronto Western Hospital (UHN)
Toronto, Ontario, Canada
RECRUITINGTrial 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.
Time frame: 30 days
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.
Time frame: 30 days
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.
Time frame: 30 days
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.
Time frame: 30 days
Trial safety
Safety will be assessed as the number of participants experiencing intervention-related adverse or serious adverse events.
Time frame: 30 days
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
Time frame: Before surgery, on day of surgery, and days 1,2,3 after surgery
Opioid consumption
Oral morphine equivalents (OMEQS) in milligrams
Time frame: Before surgery, on day of surgery, and days 1,2,3 after surgery
Delirium
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
Cognitive dysfunction
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)
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
Time frame: Baseline and at 30 days after surgery
Depression screen
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)
Ambulation
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)
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.
Time frame: On day of surgery, days 1,2, 3 after surgery, and at 30 days after surgery
Discharge location
Location of discharge after surgery
Time frame: At the time of discharge (at 1-3 days after surgery in most cases)
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