Actively Recruiting
Led by University Health Network, Toronto · Updated on 2025-05-30
42
Participants Needed
1
Research Sites
26 weeks
Total Duration
This trial evaluates the feasibility of conducting a randomized, double-blinded study comparing intravenous (IV) acetaminophen to oral acetaminophen for pain management after hip fracture surgery in older adults aged 60 and above. The study aims to inform a larger trial assessing whether IV acetaminophen can better reduce delirium and improve clinical and patient-centered outcomes after surgery. Participants will be randomly assigned to one of two groups. One group receives IV acetaminophen plus an oral placebo tablet, while the other gets an IV placebo (normal saline) plus oral acetaminophen. Both treatments are administered every 6 hours for 48 hours, totaling eight doses postoperatively. During the study, researchers will monitor recruitment, retention, procedure compliance, and safety within 30 days. They will also assess pain, opioid use, delirium, cognitive function, overall health, depression, ambulation, adverse events, and discharge location from before surgery up to 30 days after. The trial is led by the University Health Network, Toronto, and participants will be closely followed for these outcomes.
CONDITIONS
Intravenous vs Oral Acetaminophen in Postoperative Hip Fracture Adult Patients
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 48 hours
Participants receive either intravenous acetaminophen with oral placebo or intravenous placebo with oral acetaminophen postoperatively every 6 hours for 48 hours, totaling 8 doses.
1 baseline visit and daily visits during treatment
Duration - Up to 30 days after surgery
Participants are assessed for postoperative pain, opioid consumption, delirium, cognitive function, overall health, disability, depression, ambulation, adverse events, and discharge location up to 30 days after surgery.
Visits on the day of surgery, days 1, 2, 3 after surgery, and at 30 days post-surgery
Total: 1 location
1
Toronto Western Hospital (UHN)
Toronto, Ontario, Canada, M5T 2S8
Actively Recruiting
L
Laurentia Enesi
A
Aparna P Saripella
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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