A Phase 4 interventional study of IV Acetaminophen in Post Operative Analgesia, Opioid Consumption, Postoperative and Acetaminophen, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-11.
Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Phase 4, Interventional, and Supportive care
Acetaminophen (Tylenol) is a commonly used medication after surgery to control pain. Tablets for oral use and suppositories for rectal use are the most frequently employed forms of acetaminophen after surgery. Intravenous (IV) acetaminophen is widely used in several countries but is not a standard medication for the adult population in Canada. It is mainly considered when it is impossible to take medication in tablet or suppository form. Opioids (Morphine, Hydromorphone, Oxycodone, etc.) are another class of medications commonly used after surgery for pain management. While they are generally very effective and stronger than acetaminophen or other pain relievers (e.g., ibuprofen/Advil), reducing their use is preferable, as they can cause various side effects such as nausea, dizziness, and dependence. IV acetaminophen may help control pain while also reducing opioid consumption. However, there are few high-quality scientific studies proving the benefits of IV acetaminophen compared to other forms, such as tablets or suppositories. Acetaminophen has been available in Canada for many years and has already been recommended for use in Quebec by the Institut national d'excellence en santé et services sociaux (INESSS) under certain conditions. This study aims to validate its benefits with clear data.
In 2019, the Institut national d'excellence en santé et services sociaux (INESSS) stated that IV acetaminophen is an acceptable short-term pain treatment option in combination with opioid analgesics for adults and children aged two years and older when oral (PO) and rectal (IR) acetaminophen cannot be used. Despite this recommendation, there is limited data on IV acetaminophen in patients with a compromised enteral route, even though this is likely one of the populations that could benefit the most from such an intervention. Patients undergoing abdominal surgeries are a prominent example of individuals with a compromised enteral route. Some data exist for other types of surgeries, such as orthopedic surgery. However, such data is challenging to extrapolate to abdominal surgeries since orthopedic surgery does not affect the digestive system. Furthermore, several studies use comparators that do not accurately reflect clinical practice, such as placebo. This study will therefore use standard treatment as a comparator, allowing for a better assessment of IV acetaminophen's role in the therapeutic arsenal.
IV acetaminophen is approved and marketed in Canada. It is not an investigational product. Furthermore, it is currently used in other hospital centers and has already been used at the Centre hospitalier de l'Université de Montréal (CHUM). Given current budgetary limitations, PO and IR formulations of acetaminophen have been preferred over the IV formulation, as their economic burden is less than IV acetaminophen.
Currently, pharmacists play a central role in the healthcare system as medication experts and key players in patient care in both community and hospital settings. Over the years, pharmacists in Québec have also become prescribers by law. They are valuable allies in hospitals, ensuring proper treatment follow-up and continuously validating that pharmacological care standards for patients of the CHUM are met.
The research question is as follows: Compared to standard local postoperative treatment, does IV acetaminophen reduce the amount of opioids administered within the first 72 postoperative hours in patients with a compromised enteral route in the abdominal surgery units of a Québec university hospital center?
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Exclusion Criteria:
This arm will receive the protocol currently used at the CHUM surgical units for post operative pain management, which includes PO or IR acetaminophen.
This arm will receive a modified protocol version of the one used at the CHUM surgical units for post operative pain management, which includes IV acetaminophen.
Drug: IV Acetaminophen
This intervention will be administered to patients undergoing abdominal surgery who are nil per os (NPO) directly after surgery. This patient group has not been properly studied in other clinical studies using IV Acetaminophen. The study aim is to determine if patients who have an altered enteral route may benefit from IV Acetaminophen.
Opioid consumption in oral morphine milligram equivalents (MME)
To determine whether the systematic use of IV acetaminophen in adult NPO patients in the postoperative context of abdominal surgery (post-intervention) reduces the average opioid consumption in oral morphine milligram equivalents (MME) over 72 hours compared to the standard protocol, which includes PO or IR acetaminophen (pre-intervention).
Time frame: 72 hours
Opioid consumption (converted to MME) at 24 and 48 hours postoperatively
To determine whether the systematic use of IV acetaminophen reduces the average opioid consumption in MME over the first 24 and 48 postoperative hours in the post-intervention period compared to the pre-intervention period.
Time frame: 48 hours
Pain level at rest (on a scale from 0 to 10) during the first 72 hours.
Compare the variation in resting pain levels during the periods of 0 to 24 hours, 24 to 48 hours, 0 to 48 hours, 48 to 72 hours, and 0 to 72 hours between the pre-intervention and post-intervention periods. This simple scale asks patients to rate their pain on a scale from zero (no pain) to ten (maximum pain).
Time frame: 72 hours
Pain level during mobilization (on a scale from 0 to 10) during the first 72 hours
Compare the average pain level during mobilization (upon standing) on postoperative days 0, 1, and 2 between the pre-intervention and post-intervention periods. This simple scale asks patients to rate their pain on a scale from zero (no pain) to ten (maximum pain)
Time frame: 72 hours
Length of hospital stay
Compare the length of hospital stay in days from the end of surgery until hospital discharge between the pre-intervention and post-intervention periods.
Time frame: From date of the abdominal surgery until the date of hospital discharge, assessed up to 6 months
Nausea and constipation (antiemetic doses, laxative use)
Compare the frequency of nausea and constipation between the pre-intervention and post-intervention periods
Time frame: 72 hours
Functionality: time to first mobilization, mean chair time on postoperative days 1 and 2, time to return of oral intake, time to epidural discontinuation.
Compare the average time (in days) before the return of an uncompromised enteral route, complete epidural weaning, and first mobilization (first time standing up) between the pre-intervention and post-intervention periods. Compare the average time spent seated in a chair on postoperative days 1 and 2 between the pre-intervention and post-intervention periods.
Time frame: 72 hours
Plan to share: No
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Studies of the drug tested here: Acetaminophen
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