Intravenous vs Oral Acetaminophen in Postoperative Hip Fracture Adult Patients
INTACT-HIP: INTravenous Acetaminophen vs. Oral Randomized Controlled Trial in HIP Fracture Patients - a Feasibility Trial
University Health Network, Toronto
42 participants
Jan 23, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria9
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Postoperatively patients will receive both a tablet and an IV solution every 6 hours for 48 hours, for a total of 8 doses. In this group, the IV study drug will be IV acetaminophen and the oral study drug will be a placebo tablet.
Postoperatively patients will receive both a tablet and an IV solution every 6 hours for 48 hours, for a total of 8 doses. In this group the IV study drug will be normal saline and the pill will be acetaminophen
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05425355