Intravenous vs Oral Acetaminophen in Postoperative Hip Fracture Adult Patients

Condition(s) studied

Investigational drug(s) / intervention(s)

Intravenous (IV) acetaminophen + oral placebo: Postoperatively patients will receive both a tablet and an IV solution every 6 hours for 48 hours, for a total of 8 doses. In this group, the IV study drug will be IV acetaminophen and the oral study drug will be a placebo tablet.

Intravenous (IV) placebo plus oral acetaminophen: Postoperatively patients will receive both a tablet and an IV solution every 6 hours for 48 hours, for a total of 8 doses. In this group the IV study drug will be normal saline and the pill will be acetaminophen

Study 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

Primary outcome measure(s)

• Trial feasibility-Recruitment — 30 days
  Feasibility as assessed by recruitment rate. This will be assesses as proportion of patients enrolled in the study compared to the number of patients meeting the inclusion/exclusion criteria.
• Trial feasibility-Attrition — 30 days
  Feasibility as assessed by attrition rates. This will be defined as the proportion of patients completing the study at follow-up compared to the enrolled patients.
• Trial feasibility-Availability of human resources — 30 days
  Feasibility as assessed by lack of availability of human resources). Inability to include patient in study due to lack of pharmacist or research assistant availability will be documented.
• Trial feasibility-Comply study procedures — 30 days
  Feasibility as assessed by failure to comply with study procedures. Failure to provide study drug at scheduled time will be documented.
• Trial safety — 30 days
  Safety will be assessed as the number of participants experiencing intervention-related adverse or serious adverse events.

Trial sites (1)

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