Intravenous vs Oral Acetaminophen in Postoperative Hip Fracture Adult Patients
NCT ID: NCT05425355
Last Updated: 2025-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
42 participants
INTERVENTIONAL
2023-01-23
2026-06-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Intravenous (IV) acetaminophen plus oral placebo
In this group, the IV study drug will be IV acetaminophen and the oral study drug will be a placebo tablet.
Intravenous (IV) acetaminophen + oral placebo
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.
Intravenous (IV) placebo plus oral acetaminophen
In this group the IV study drug will be normal saline and the pill will be acetaminophen
Intravenous (IV) placebo plus oral acetaminophen
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
Interventions
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Intravenous (IV) acetaminophen + oral placebo
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.
Intravenous (IV) placebo plus oral acetaminophen
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
60 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Jean Wong
Associate Professor, University of Toronto, Department of Anesthesiology and Pain Medicine
Principal Investigators
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Jean Wong, MD
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Locations
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Toronto Western Hospital (UHN)
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Dr. Jean Wong, MD
Role: primary
Dr.Simone Schiavo, MD
Role: backup
References
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Jahr JS, Breitmeyer JB, Pan C, Royal MA, Ang RY. Safety and efficacy of intravenous acetaminophen in the elderly after major orthopedic surgery: subset data analysis from 3, randomized, placebo-controlled trials. Am J Ther. 2012 Mar;19(2):66-75. doi: 10.1097/MJT.0b013e3182456810.
Chen DX, Yang L, Ding L, Li SY, Qi YN, Li Q. Perioperative outcomes in geriatric patients undergoing hip fracture surgery with different anesthesia techniques: A systematic review and meta-analysis. Medicine (Baltimore). 2019 Dec;98(49):e18220. doi: 10.1097/MD.0000000000018220.
Harris MJ, Brovman EY, Urman RD. Clinical predictors of postoperative delirium, functional status, and mortality in geriatric patients undergoing non-elective surgery for hip fracture. J Clin Anesth. 2019 Dec;58:61-71. doi: 10.1016/j.jclinane.2019.05.010. Epub 2019 May 14.
Other Identifiers
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21-5733
Identifier Type: -
Identifier Source: org_study_id
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