Intravenous vs Oral Acetaminophen in Postoperative Hip Fracture Adult Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Hip-fracture, Surgery

Intervention / Treatment
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* Drug: Intravenous (IV) acetaminophen + oral placebo
* Drug: Intravenous (IV) placebo plus oral acetaminophen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravenous (IV) acetaminophen plus oral placebo<br>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<br>* 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.<br>|
| Active Comparator: Intravenous (IV) placebo plus oral acetaminophen<br>In this group the IV study drug will be normal saline and the pill will be acetaminophen | Drug: Intravenous (IV) placebo plus oral acetaminophen<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Opioid consumption | Oral morphine equivalents (OMEQS) in milligrams | Before surgery, on day of surgery, and days 1,2,3 after surgery | 
| 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 | 
| 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) | 
| 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 | 
| 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) | 
| 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) | 
| 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 | 
| Discharge location | Location of discharge after surgery | At the time of discharge (at 1-3 days after surgery in most cases) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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elderly, acetaminophen, oral vs intravenous, hip fracture surgery