Intravenous vs Oral Acetaminophen in Postoperative Hip Fracture Adult Patients

Surgery Clinical Trial

— INTACT-HIP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05425355
• Other study ID #: 21-5733
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: November 4, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: October 2022
• Source: University Health Network, Toronto
• Contact: Nayeemur Rahman
• Phone: 416-603-5800
• Email: Nayeemur.Rahman[@]uhnresearch.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: June 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures
• Hip-fracture
• Surgery

Intervention

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.
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

References & Publications (3)

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: 10.10 — View 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. — View 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: 10.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Trial safety	Safety will be assessed as the number of participants experiencing intervention-related adverse or serious adverse events.	30 days
Secondary	Postoperative pain	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	Before surgery, on day of surgery, and days 1,2,3 after surgery
Secondary	Opioid consumption	Oral morphine equivalents (OMEQS) in milligrams	Before surgery, on day of surgery, and days 1,2,3 after surgery
Secondary	Delirium	Delirium incidence will be measured using the Confusion assessment method (CAM)-Long Form	On day of surgery, and days 1,2, 3 after surgery
Secondary	Cognitive dysfunction	Cognitive dysfunction will be assessed using the Montreal Cognitive Assessment (MoCA)	Before surgery and day 3 after surgery (or at discharge time if hospital stay less than 3 days after surgery)
Secondary	Overall health and disability	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	Baseline and at 30 days after surgery
Secondary	Depression screen	Patient Health Questionnaire (PHQ)-2 a 2-question questionnaire will be used as a validated measure to screen for depression.	Before surgery and day 3 after surgery (or at discharge time if hospital stay less than 3 days after surgery)
Secondary	Ambulation	Ambulation will be assessed as the ability to walk 10 feet or across a room without human assistance	Before surgery and day 3 after surgery (or at discharge time if hospital stay less than 3 days after surgery)
Secondary	Post-operative adverse events	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.	On day of surgery, days 1,2, 3 after surgery, and at 30 days after surgery
Secondary	Discharge location	Location of discharge after surgery	At the time of discharge (at 1-3 days after surgery in most cases)