Intravenous vs Oral Acetaminophen in Postoperative Hip Fracture Adult Patients
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversity Health Network, Toronto
About this trial
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
Qualifiers
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
Disqualifiers
Patients with neoplastic hip fracture
Severe cognitive impairment (Montreal Cognitive Assessment (MoCA) <10)
Pre-existing delirium
Known hypersensitivity or allergy to acetaminophen
Trial design
Treatments tested in this trial
- Intravenous (IV) acetaminophen + oral placebo
- Intravenous (IV) placebo plus oral acetaminophen
Treatment groups
42 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov