RecruitingPhase 4NCT05425355

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


Sponsor

University Health Network, Toronto

Enrollment

42 participants

Start Date

Jan 23, 2023

Study Type

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

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Intravenous (IV) acetaminophen + oral placebo and a drug called Intravenous (IV) placebo plus oral acetaminophen for people with hip fracture and surgery. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIntravenous (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.

DRUGIntravenous (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


Locations(1)

Toronto Western Hospital (UHN)

Toronto, Ontario, Canada

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NCT05425355


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