NCT05425355

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hip-fracture
• Surgery

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-01-23
• Primary completion: 2025-12-30
• Completion: 2026-06-30
• First posted: 2022-06-21
• Last updated: 2025-05-30

Locations

1 site across 1 country: Canada