Intravenous vs Oral Acetaminophen in Postoperative Hip Fracture Adult Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intravenous (IV) acetaminophen + oral placebo, Intravenous (IV) placebo plus oral acetaminophen.
- Who it may be relevant to
- Registry conditions: Hip-fracture, Surgery. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
INTACT-HIP: INTravenous Acetaminophen vs. Oral Randomized Controlled Trial in HIP Fracture Patients - a Feasibility Trial
Overview
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.
Interventions
- Drug 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. - Drug 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 measures
- 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]
Secondary outcome measures (9)
- Postoperative pain [Time frame: Before surgery, on day of surgery, and days 1,2,3 after surgery]
- Opioid consumption [Time frame: Before surgery, on day of surgery, and days 1,2,3 after surgery]
- Delirium [Time frame: On day of surgery, and days 1,2, 3 after surgery]
- Cognitive dysfunction [Time frame: Before surgery and day 3 after surgery (or at discharge time if hospital stay less than 3 days after surgery)]
- Overall health and disability [Time frame: Baseline and at 30 days after surgery]
- Depression screen [Time frame: Before surgery and day 3 after surgery (or at discharge time if hospital stay less than 3 days after surgery)]
- Ambulation [Time frame: Before surgery and day 3 after surgery (or at discharge time if hospital stay less than 3 days after surgery)]
- Post-operative adverse events [Time frame: On day of surgery, days 1,2, 3 after surgery, and at 30 days after surgery]
- Discharge location [Time frame: At the time of discharge (at 1-3 days after surgery in most cases)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Toronto Western Hospital (UHN) — Toronto
Publications
- 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
- 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
- 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
Identifiers
NCT: NCT05425355 · 21-5733