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Intravenous vs Oral Acetaminophen in Postoperative Hip Fracture Adult Patients

RecruitingPhase 4Ages 60 Years - anyAllUniversity Health Network, Toronto
NCT05425355 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Intravenous (IV) acetaminophen + oral placebo
  • Intravenous (IV) placebo plus oral acetaminophen
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Where

1 site
Toronto Western Hospital (UHN)
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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