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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• 60 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

Locations
Other Locations
Canada
Toronto Western Hospital (UHN)
RECRUITING
Toronto
Contact Information
Primary
Laurentia Enesi
laurentia.enesi@uhn.ca
416-603-5800
Backup
Aparna P Saripella
aparna.saripella@uhn.ca
416-603-5800
Time Frame
Start Date: 2023-01-23
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 42
Treatments
Experimental: 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.
Active_comparator: Intravenous (IV) placebo plus oral acetaminophen
In this group the IV study drug will be normal saline and the pill will be acetaminophen
Related Therapeutic Areas
Sponsors
Leads: University Health Network, Toronto

This content was sourced from clinicaltrials.gov