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RECRUITING
NCT05425355
PHASE4

Intravenous vs Oral Acetaminophen in Postoperative Hip Fracture Adult Patients

Sponsor: University Health Network, Toronto

View on ClinicalTrials.gov

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.

Official title: INTACT-HIP: INTravenous Acetaminophen vs. Oral Randomized Controlled Trial in HIP Fracture Patients - a Feasibility Trial

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2023-01-23

Completion Date

2026-06-30

Last Updated

2025-05-30

Healthy Volunteers

No

Interventions

DRUG

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.

DRUG

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

Locations (1)

Toronto Western Hospital (UHN)

Toronto, Ontario, Canada