Intravenous vs Oral Acetaminophen in Postoperative Hip Fracture Adult Patients

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Treatments: Acetaminophen

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