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NCT Number: NCT05425355

Intravenous vs Oral Acetaminophen in Postoperative Hip Fracture Adult Patients

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.

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Key information

Conditions

Hip-fracture Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Surgery Wounds and Injuries

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Toronto Western Hospital (UHN)

Toronto, Ontario, M5T 2S8, Canada

Location status: Recruiting

Location contact

Dr. Jean Wong, MD

CONTACT

Dr.Simone Schiavo, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous (IV) acetaminophen + oral placebo

Drug

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

Drug

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 outcomes

  1. Trial feasibility-Recruitment

    Time frame: 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.

  2. Trial feasibility-Attrition

    Time frame: 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.

  3. Trial feasibility-Availability of human resources

    Time frame: 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.

  4. Trial feasibility-Comply study procedures

    Time frame: 30 days

    Feasibility as assessed by failure to comply with study procedures. Failure to provide study drug at scheduled time will be documented.

  5. Trial safety

    Time frame: 30 days

    Safety will be assessed as the number of participants experiencing intervention-related adverse or serious adverse events.

Secondary outcomes

  1. Postoperative pain

    Time frame: Before surgery, on day of surgery, and days 1,2,3 after surgery

    Pain will be assessed using the visual analogue (VAS) scale (0-10) at rest and movement, with 0=no pain and 10=worst pain possible

  2. Opioid consumption

    Time frame: Before surgery, on day of surgery, and days 1,2,3 after surgery

    Oral morphine equivalents (OMEQS) in milligrams

  3. Delirium

    Time frame: On day of surgery, and days 1,2, 3 after surgery

    Delirium incidence will be measured using the Confusion assessment method (CAM)-Long Form

  4. Cognitive dysfunction

    Time frame: Before surgery and day 3 after surgery (or at discharge time if hospital stay less than 3 days after surgery)

    Cognitive dysfunction will be assessed using the Montreal Cognitive Assessment (MoCA)

  5. Overall health and disability

    Time frame: Baseline and at 30 days after surgery

    Overall health and disability will be measured using the WHO Disability Assessment Schedule, version 2.0 (WHODAS 2.0), a 12-item validated measure that assesses cognition, mobility, self-care, interpersonal relationships, work and household roles, and participation in society

  6. Depression screen

    Time frame: Before surgery and day 3 after surgery (or at discharge time if hospital stay less than 3 days after surgery)

    Patient Health Questionnaire (PHQ)-2 a 2-question questionnaire will be used as a validated measure to screen for depression.

  7. Ambulation

    Time frame: Before surgery and day 3 after surgery (or at discharge time if hospital stay less than 3 days after surgery)

    Ambulation will be assessed as the ability to walk 10 feet or across a room without human assistance

  8. Post-operative adverse events

    Time frame: On day of surgery, days 1,2, 3 after surgery, and at 30 days after surgery

    Post-operative adverse events will be obtained from the study institution's National Surgical Quality Improvement Project (NSQIP) database as as death, ICU admission, standardized cardiac, respiratory and neurological postoperative events, and readmission to hospital.

  9. Discharge location

    Time frame: At the time of discharge (at 1-3 days after surgery in most cases)

    Location of discharge after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Aparna P Saripella

CONTACT

[email protected]

416-603-5800 ext. 6137

Laurentia Enesi

CONTACT

[email protected]

416-603-5800 ext. 3959

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

INTACT-HIP: INTravenous Acetaminophen vs. Oral Randomized Controlled Trial in HIP Fracture Patients - a Feasibility Trial

Acronym: INTACT-HIP

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 21, 2022
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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