Comparing intravenous and oral acetaminophen for pain management after hip fracture surgery in older adults
INTACT-HIP: INTravenous Acetaminophen vs. Oral Randomized Controlled Trial in HIP Fracture Patients - a Feasibility Trial
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 |
| Enrollment | 42 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05425355 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with neoplastic hip fractures, severe cognitive impairment, or other significant health issues may not benefit from this study.
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 performed: While this specific approach is novel, previous studies have explored similar pain management strategies, indicating potential for success.
Eligibility criteria
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 this trial is running
Toronto, Ontario
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.