NCT05425355 Intravenous vs Oral Acetaminophen in Postoperative Hip Fracture Adult Patients
| NCT ID | NCT05425355 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University Health Network, Toronto |
| Condition | Hip-fracture |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2023-01-23 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 42 participants in total. It began in 2023-01-23 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Patients with neoplastic hip fracture * 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
Contact & Investigator
Jean Wong, MD
PRINCIPAL INVESTIGATOR
University Health Network, Toronto
Frequently Asked Questions
Who can join the NCT05425355 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Hip-fracture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05425355 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05425355 currently recruiting?
Yes, NCT05425355 is actively recruiting participants. Contact the research team at laurentia.enesi@uhn.ca for enrollment information.
Where is the NCT05425355 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT05425355 clinical trial?
NCT05425355 is sponsored by University Health Network, Toronto. The principal investigator is Jean Wong, MD at University Health Network, Toronto. The trial plans to enroll 42 participants.