Intravenous vs Oral Acetaminophen in Postoperative Hip Fracture Adult Patients

NCT05425355 | Recruiting Phase 4

• 1 other identifier: 21-5733
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Keywords

elderly; acetaminophen; oral vs intravenous; hip fracture surgery

Outcome Measures

Primary Outcomes (5)

• Trial feasibility-Recruitment

  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.

  30 days

• Trial feasibility-Attrition

  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.

  30 days

• Trial feasibility-Availability of human resources

  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.

  30 days

• Trial feasibility-Comply study procedures

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

  30 days

• Trial safety

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

  30 days

Secondary Outcomes (9)

• Postoperative pain

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

• Opioid consumption

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

• Delirium

  On day of surgery, and days 1,2, 3 after surgery

• Cognitive dysfunction

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

• Overall health and disability

  Baseline and at 30 days after surgery

Study Arms (2)

Intravenous (IV) acetaminophen plus oral placebo

EXPERIMENTAL

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

Drug: Intravenous (IV) acetaminophen + oral placebo

Intravenous (IV) placebo plus oral acetaminophen

ACTIVE COMPARATOR

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

Drug: Intravenous (IV) placebo plus oral acetaminophen

Interventions

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) acetaminophen plus oral placebo

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

Intravenous (IV) placebo plus oral acetaminophen

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify 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
• Swallowing issues and/or dysphagia
• English language limitation
• Weight \<50kg

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital (UHN)

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

Related Publications (3)

• Jahr JS, Breitmeyer JB, Pan C, Royal MA, Ang RY. Safety and efficacy of intravenous acetaminophen in the elderly after major orthopedic surgery: subset data analysis from 3, randomized, placebo-controlled trials. Am J Ther. 2012 Mar;19(2):66-75. doi: 10.1097/MJT.0b013e3182456810.

  PMID: 22354127 RESULT

• Chen DX, Yang L, Ding L, Li SY, Qi YN, Li Q. Perioperative outcomes in geriatric patients undergoing hip fracture surgery with different anesthesia techniques: A systematic review and meta-analysis. Medicine (Baltimore). 2019 Dec;98(49):e18220. doi: 10.1097/MD.0000000000018220.

  PMID: 31804347 RESULT

• Harris MJ, Brovman EY, Urman RD. Clinical predictors of postoperative delirium, functional status, and mortality in geriatric patients undergoing non-elective surgery for hip fracture. J Clin Anesth. 2019 Dec;58:61-71. doi: 10.1016/j.jclinane.2019.05.010. Epub 2019 May 14.

  PMID: 31100691 RESULT

MeSH Terms

Conditions

Hip Fractures

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Jean Wong, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurentia Enesi

CONTACT

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

Aparna P Saripella

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, University of Toronto, Department of Anesthesiology and Pain Medicine

Model Details: The study intervention will start after the surgery for the hip fracture with administration of the study drugs, starting in the post-anesthesia care unit (PACU). All patients will receive both a tablet and an IV solution every 6 hours for 48 hours, for a total of 8 doses. In the intravenous (IV) group, the IV study drug will be IV acetaminophen and the oral study drug will be a placebo tablet; vice versa, in the per oral (PO) group, the IV study drug will be normal saline and the pill will be acetaminophen. After 48 hours, all the patients will receive oral acetaminophen every 6 hours as per usual practice

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: June 21, 2022
• Study Start: January 23, 2023
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)