Hip-fracturePhase 4INTACT-HIPNCT05425355
Intravenous vs Oral Acetaminophen in Postoperative Hip Fracture Adult Patients
A Phase 4 study of Hip-fracture and Surgery, run by University Health Network, Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hip-fracture, Surgery
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- 23 Jan 2023to 30 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Swallowing issues and/or dysphagia
- English language limitation
- Weight <50kg
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Toronto Western Hospital (UHN)
Toronto, Ontario, M5T 2S8
Dr. Jean Wong, MD
Dr.Simone Schiavo, MD
About this study
Official title: INTACT-HIP: INTravenous Acetaminophen vs. Oral Randomized Controlled Trial in HIP Fracture Patients - a Feasibility 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.
- Conditions
- Hip-fracture, Surgery
- Being tested
- Intravenous (IV) acetaminophen + oral placebo, Intravenous (IV) placebo plus oral acetaminophen
- Keywords
- elderly, acetaminophen, oral vs intravenous, hip fracture surgery
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous (IV) acetaminophen + oral placeboDrug
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 acetaminophenDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Intravenous (IV) acetaminophen plus oral placebo | Experimental | In this group, the IV study drug will be IV acetaminophen and the oral study drug will be a placebo tablet. Receives: Drug: Intravenous (IV) acetaminophen + oral placebo |
| Intravenous (IV) placebo plus oral acetaminophen | Active comparator | In this group the IV study drug will be normal saline and the pill will be acetaminophen Receives: Drug: Intravenous (IV) placebo plus oral acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 days
Trial safety
Safety will be assessed as the number of participants experiencing intervention-related adverse or serious adverse events.
Measured: 30 days
Secondary outcomes (9)
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
Measured: Before surgery, on day of surgery, and days 1,2,3 after surgery
Opioid consumption
Oral morphine equivalents (OMEQS) in milligrams
Measured: 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
Measured: On day of surgery, and days 1,2, 3 after surgery
Cognitive dysfunction
Cognitive dysfunction will be assessed using the Montreal Cognitive Assessment (MoCA)
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: On day of surgery, days 1,2, 3 after surgery, and at 30 days after surgery
Discharge location
Location of discharge after surgery
Measured: At the time of discharge (at 1-3 days after surgery in most cases)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start23 Jan 2023
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hip-fractureStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean Wong, University Health Network, Toronto
- Investigators
- Jean Wong, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05425355
- Sponsor's protocol ID
- 21-5733
- Acronym
- INTACT-HIP
- Status last verified
- Jul 2026
- First submitted
- 16 May 2022
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 22354127Chen 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.
PubMed 31804347Harris 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.
PubMed 31100691
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INTACT-HIP: INTravenous Acetaminophen vs. Oral Randomized Controlled Trial in HIP Fracture Patients - a Feasibility Trial
- ClinicalTrials.gov ID
- NCT05425355
- Acronym / sponsor ID
- INTACT-HIP / 21-5733
- Conditions
- Hip-fracture, Surgery
- Keywords
- elderly, acetaminophen, oral vs intravenous, hip fracture surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Intravenous (IV) acetaminophen plus oral placebo | Experimental | Drug: Intravenous (IV) acetaminophen + oral placeboIn 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 | Active comparator | Drug: Intravenous (IV) placebo plus oral acetaminophenIn this group the IV study drug will be normal saline and the pill will be acetaminophen |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous (IV) acetaminophen + oral placeboPostoperatively 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) acetaminophen plus oral placebo |
| Intravenous (IV) placebo plus oral acetaminophenPostoperatively 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 | Drug | Intravenous (IV) placebo plus oral acetaminophen |
Primary outcome
Trial feasibility-Recruitment
Time frame: 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
Time frame: 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
Time frame: 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.
Trial feasibility-Comply study procedures
Time frame: 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
Time frame: 30 days
Safety will be assessed as the number of participants experiencing intervention-related adverse or serious adverse events.
9 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Results publication: PubMed 22354127Jahr 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.
- Results publication: PubMed 31804347Chen 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.
- Results publication: PubMed 31100691Harris 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean Wong, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Hip-fracture and Surgery, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurentia Enesi (416-603-5800 ext. 3959, laurentia.enesi@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trial feasibility-Recruitment (time frame: 30 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05425355, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.