Intravenous vs Oral Acetaminophen in Postoperative Hip Fracture Adult Patients
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversity Health Network, Toronto
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients with neoplastic hip fracture
Severe cognitive impairment (Montreal Cognitive Assessment (MoCA) <10)
Pre-existing delirium
Known hypersensitivity or allergy to acetaminophen
Trial design
Design model
Parallel
Treatments tested in this trial
Intravenous (IV) acetaminophen + oral placebo
DrugPostoperatively 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
DrugPostoperatively 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
Treatment groups
42 Participants
are divided into 2 treatment groupsGroup A: Intravenous (IV) acetaminophen plus oral placeboExperimental treatment 1 intervention
Group B: Intravenous (IV) placebo plus oral acetaminophenActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
30 days2
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.
Time frame
30 days3
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.
Time frame
30 days4
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.
Time frame
30 daysSecondary outcomes
1
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
Time frame
Before surgery, on day of surgery, and days 1,2,3 after surgery2
Opioid consumption
Oral morphine equivalents (OMEQS) in milligrams
Time frame
Before surgery, on day of surgery, and days 1,2,3 after surgery3
Delirium
Delirium incidence will be measured using the Confusion assessment method (CAM)-Long Form
Time frame
On day of surgery, and days 1,2, 3 after surgery4
Cognitive dysfunction
Cognitive dysfunction will be assessed using the Montreal Cognitive Assessment (MoCA)
Time frame
Before surgery and day 3 after surgery (or at discharge time if hospital stay less than 3 days after surgery)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov