Recruiting

Acetaminophen vs. Acetaminophen

Sponsor:

University Health Network, Toronto

Code:

NCT05425355

Conditions

Hip-fracture

Surgery

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Intravenous (IV) acetaminophen + oral placebo

Intravenous (IV) placebo plus oral acetaminophen

Study Details

Brief 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.

Conditions

Hip-fracture

Surgery

Study ID

NCT05425355

Start date

Jan 23, 2023

Status verified date

Jul, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Aug 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intravenous (IV) acetaminophen plus oral placebo

In this group, the IV study drug will be IV acetaminophen and the oral study drug will be a placebo tablet.

active comparator: Intravenous (IV) placebo plus oral acetaminophen

In this group the IV study drug will be normal saline and the pill will be acetaminophen

Interventions

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

Primary outcome measure

  • Trial feasibility-Recruitment [ Time Frame: 30 days ]
  • Trial feasibility-Attrition [ Time Frame: 30 days ]
  • Trial feasibility-Availability of human resources [ Time Frame: 30 days ]
  • Trial feasibility-Comply study procedures [ Time Frame: 30 days ]
  • Trial safety [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Laurentia Enesi

416-603-5800laurentia.enesi@uhn.ca

Aparna P Saripella

416-603-5800aparna.saripella@uhn.ca

Locations

Toronto Western Hospital (UHN)

Recruiting

Toronto, Ontario, Canada, M5T 2S8

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Keywords

  • elderly
  • acetaminophen
  • oral vs intravenous
  • hip fracture surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-07-23.