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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous (IV) acetaminophen + oral placebo | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laurentia Enesi | Contact | 416-603-5800 | 3959 | laurentia.enesi@uhn.ca |
| Aparna P Saripella | Contact | 416-603-5800 | 6137 | aparna.saripella@uhn.ca |
| Name | Affiliation | Role |
|---|---|---|
| Jean Wong, MD | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto Western Hospital (UHN) | Recruiting | Toronto | Ontario | M5T 2S8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22354127 | Result | 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. | |
| 31804347 | Result | 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: 10.1097/MD.0000000000018220. |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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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
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Quadruple blinded
|
| Intravenous (IV) placebo plus oral acetaminophen | Drug | 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 |
|
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) |
| 31100691 | Result | 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. Epub 2019 May 14. |
| D007869 |
| Leg Injuries |
| Aniline Compounds |
| D000588 | Amines |