Intravenous vs Oral Acetaminophen in Postoperative Hip Fracture Adult Patients

Phase 4

Not yet recruiting

• Conditions: Surgery; Hip-fracture
• Interventions: Drug: Intravenous (IV) placebo plus oral acetaminophen; Drug: Intravenous (IV) acetaminophen + oral placebo

• Registration Number: NCT05425355
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-16
• Study First Submitted QC: 2022-06-15
• Study First Posted: 2022-06-21
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-02
• Study Start: 2022-11-04
• Primary Completion: 2024-03-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 42

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous (IV) placebo plus oral acetaminophen	Intravenous (IV) placebo plus oral acetaminophen	In this group the IV study drug will be normal saline and the pill will be acetaminophen
Intravenous (IV) acetaminophen plus oral placebo	Intravenous (IV) acetaminophen + oral placebo	In this group, the IV study drug will be IV acetaminophen and the oral study drug will be a placebo tablet.

Primary Outcome Measures

Name	Time	Method
Trial feasibility-Comply study procedures	30 days	Feasibility as assessed by failure to comply with study procedures. Failure to provide study drug at scheduled time will be documented.
Trial safety	30 days	Safety will be assessed as the number of participants experiencing intervention-related adverse or serious adverse events.
Trial feasibility-Recruitment	30 days	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.
Trial feasibility-Attrition	30 days	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.
Trial feasibility-Availability of human resources	30 days	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.

Secondary Outcome Measures

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