Intravenous Vs Oral Acetaminophen in Postoperative Hip Fracture Adult Patients (INTACT-HIP)

University Health Network, Toronto

Status and phase: Enrolling; Phase 4

Conditions: Hip-fracture; Surgery

Treatments: Drug: Intravenous (IV) acetaminophen + oral placebo; Drug: Intravenous (IV) placebo plus oral acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT05425355

21-5733

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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
• Weight <50kg

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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42 participants in 2 patient groups

Intravenous (IV) acetaminophen plus oral placebo

Experimental group

Description:

In this group, the IV study drug will be IV acetaminophen and the oral study drug will be a placebo tablet.

Treatment:

Drug: Intravenous (IV) acetaminophen + oral placebo

Intravenous (IV) placebo plus oral acetaminophen

Active Comparator group

Description:

In this group the IV study drug will be normal saline and the pill will be acetaminophen

Treatment:

Drug: Intravenous (IV) placebo plus oral acetaminophen