Recruiting PHASE4 Hip-fracture

Compares treatment options for Hip-fracture

Official title Intravenous vs Oral Acetaminophen in Postoperative Hip Fracture Adult Patients

ClinicalTrials.gov ID: NCT05425355

What this study is testing

What it's testing
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.
  • Phase 4: studies an already-approved treatment
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 60 and older

You may be able to join if

  • 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

You likely can't join if

  • 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
See the full eligibility criteria
Who can join
  • 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
What rules you out
  • 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

The study team makes the final eligibility decision.

Where it's taking place

  • Toronto, Ontario, Canada

Compensation & support

Compensation mentioned.

ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.