Comparing intravenous and oral acetaminophen for pain management after hip fracture surgery in older adults
Official title: INTACT-HIP: INTravenous Acetaminophen vs. Oral Randomized Controlled Trial in HIP Fracture Patients - a Feasibility Trial
Run by University Health Network, Toronto · NCT05425355 · Data updated 2026-11-12
This study is testing whether giving older adults IV acetaminophen or oral acetaminophen after hip fracture surgery helps them manage pain better and recover more effectively.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 60 Years and up |
| Sex | All |
| Enrollment | 42 (estimated) |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Status | Recruiting |
| Started | January 23, 2023 |
| Main results expected | August 30, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | July 23, 2026 |
| Trial ID | NCT05425355 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 60 and older who were independently mobile prior to their hip fracture and are undergoing surgical treatment for a non-neoplastic hip fracture.
✕Probably not a fit
Patients with neoplastic hip fractures, severe cognitive impairment, or other significant health issues may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The INTACT-HIP trial will assess the feasibility of a randomized, double-blinded controlled trial comparing intravenous (IV) acetaminophen to oral acetaminophen in older adults recovering from hip fracture surgery. This study will involve 42 participants who will be randomly assigned to receive either IV acetaminophen with an oral placebo or oral acetaminophen with an IV placebo. The aim is to gather preliminary data that will inform a larger trial focused on the efficacy of these pain management strategies in reducing delirium and improving overall recovery outcomes. The results will help shape future research on postoperative care for hip fracture patients.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies that enhance recovery and reduce complications like delirium in older adults after hip surgery.
How similar studies have gone: While this specific approach is novel, previous studies have explored similar pain management strategies, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Toronto Western Hospital (UHN)
Toronto, Ontario, Canada Recruiting
Study contacts
- Principal investigator: Jean Wong, MD — University Health Network, Toronto
- Study coordinator: Laurentia Enesi
- Email: laurentia.enesi@uhn.ca
- Phone: 416-603-5800
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Total Intravenous Versus Inhalational Anesthesia in Hip Fracture Surgery
This study compares TIVA with sevoflurane anesthesia in people 65 and older undergoing hip fracture surgery to see which method helps them recover better after surgery.
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Comparison of meta-PENG vs suprainguinal fascia iliaca block for hip fracture pain
This study tests whether two ultrasound-guided nerve blocks help with pain control for adults having hip fracture surgery under spinal anesthesia.
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Frailty plus Nottingham Hip Fracture Score to predict 90-day death risk after hip surgery
This project will test whether adding a quick frailty check (Clinical Frailty Scale) to the Nottingham Hip Fracture Score helps doctors better predict 90-day death risk for people aged 60 and older having hip fracture surgery.
-
MDW blood test to predict complications and survival after hip fracture
This will test whether a routine blood measure called Monocyte Distribution Width (MDW) can help predict complications or death in people aged 65 and older who have a low-energy hip fracture.
-
Comparing regional (spinal) versus general anesthesia effects on breathing after hip fracture surgery
This study will test whether spinal (regional) or general anesthesia leads to better oxygen levels in people over 65 having hip fracture surgery.
-
Delirium Zero protocol to prevent delirium after hip fracture surgery
This trial will try whether a family-led Delirium Zero protocol (orientation poster, wall clock, and a caregiver checklist) can prevent delirium in people over 65 having hip fracture surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.