Intravenous vs Oral Acetaminophen in Postoperative Hip Fracture Adult Patients

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Hip-fracture, Surgery

In brief

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.

Key facts

Study ID

NCT05425355

Run by

University Health Network, Toronto

People needed

42

Starts

2023-01-23

Expected to finish

2026-12-30

Last updated by the study team

2026-07-23

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Weight <50kg

Where it is running

• Toronto Western Hospital (UHN) — Toronto, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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