Clinical trial NCT05425355: Intravenous vs Oral Acetaminophen in Postoperative Hip Fracture Adult Patients
Official title: INTACT-HIP: INTravenous Acetaminophen vs. Oral Randomized Controlled Trial in HIP Fracture Patients - a Feasibility Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hip-fracture
Surgery
Keywords: elderly
acetaminophen
oral vs intravenous
hip fracture surgery
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 42
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Trial feasibility-Recruitment
timeFrame: 30 days
measure: Trial feasibility-Attrition
timeFrame: 30 days
measure: Trial feasibility-Availability of human resources
timeFrame: 30 days
measure: Trial feasibility-Comply study procedures
timeFrame: 30 days
measure: Trial safety
timeFrame: 30 days
Secondary outcomes:
measure: Postoperative pain
timeFrame: Before surgery, on day of surgery, and days 1,2,3 after surgery
measure: Opioid consumption
timeFrame: Before surgery, on day of surgery, and days 1,2,3 after surgery
measure: Delirium
timeFrame: On day of surgery, and days 1,2, 3 after surgery
measure: Cognitive dysfunction
timeFrame: Before surgery and day 3 after surgery (or at discharge time if hospital stay less than 3 days after surgery)
measure: Overall health and disability
timeFrame: Baseline and at 30 days after surgery
measure: Depression screen
timeFrame: Before surgery and day 3 after surgery (or at discharge time if hospital stay less than 3 days after surgery)
measure: Ambulation
timeFrame: Before surgery and day 3 after surgery (or at discharge time if hospital stay less than 3 days after surgery)
measure: Post-operative adverse events
timeFrame: On day of surgery, days 1,2, 3 after surgery, and at 30 days after surgery
measure: Discharge location
timeFrame: At the time of discharge (at 1-3 days after surgery in most cases)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital (UHN)
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Jean Wong, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.