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Intravenous Acetaminophen to Reduce Post-operative Opioid Consumption

Evaluating the Impact of IV Acetaminophen on Opioid Consumption in the Postoperative Period in Patients Undergoing Abdominal Surgery

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06923540
Acronym
ACETAPOP
Enrollment
140
Registered
2025-04-11
Start date
2025-04-28
Completion date
2025-08-15
Last updated
2025-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Surgeries, Acetaminophen, Epidural Analgesia, Length of Stay, Mobility, Opioid Consumption, Postoperative, Pain Management, Post Operative Analgesia, Post Operative Bowel Dysfunction, Post Operative Nausea and Vomiting, Post Operative Pain Control

Keywords

IV acetaminophen, intravenous acetaminophen, acetaminophen, post operative analgesia, nil per os, npo, post operative pain, opioid consumption, abdominal surgery, hepato-biliary surgery, digestive surgery, pancreatic surgery, gynecologic surgery, post operative nausea and vomiting, post operative mobility, hospitalization length of stay, co-analgesia

Brief summary

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.

Detailed description

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?

Interventions

DRUGIV 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.

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

The study design is quasi-experimental in pre post fashion. * Part 1: participants will receive the standard post-operative protocol, which includes Acetaminophen PO or IR. * Part 2 : participants will receive the modified post-operative protocol, which includes IV Acetaminophen.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age 18 years or older. * Underwent abdominal surgery * Underwent elective surgery. * Hospitalized in the digestive surgery, hepatobiliary and pancreatic surgery, or gynecology and gynecologic oncology units at CHUM. * Declared NPO immediately post-surgery, meaning they cannot take oral medications.

Exclusion criteria

* Hypersensitivity to acetaminophen or an excipient in the administered formulations * Hepatic insufficiency with a Child-Turcotte-Pugh score of B or C. * Weight \< 50 kg (patients requiring a lower acetaminophen dose). * Active pregnancy or breastfeeding. * Opioid use disorder (OUD) under active treatment * Non-opioid-naïve patients: those who received a long-acting opioid within seven days preceding surgery. This criterion will be verified through patient interviews and cross-checked with medical records. * Use of illicit recreational substances. * Prior participation in this study. * Ectopic patients: physically located in a unit other than digestive surgery (11 South), hepatobiliary and pancreatic surgery (14 South), or gynecology and gynecologic oncology (12 South).

Design outcomes

Primary

MeasureTime frameDescription
Opioid consumption in oral morphine milligram equivalents (MME)72 hoursTo 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).

Secondary

MeasureTime frameDescription
Opioid consumption (converted to MME) at 24 and 48 hours postoperatively48 hoursTo 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.

Other

MeasureTime frameDescription
Length of hospital stayFrom date of the abdominal surgery until the date of hospital discharge, assessed up to 6 monthsCompare the length of hospital stay in days from the end of surgery until hospital discharge between the pre-intervention and post-intervention periods.
Pain level at rest (on a scale from 0 to 10) during the first 72 hours.72 hoursCompare 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).
Functionality: time to first mobilization, mean chair time on postoperative days 1 and 2, time to return of oral intake, time to epidural discontinuation.72 hoursCompare 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.
Nausea and constipation (antiemetic doses, laxative use)72 hoursCompare the frequency of nausea and constipation between the pre-intervention and post-intervention periods
Pain level during mobilization (on a scale from 0 to 10) during the first 72 hours72 hoursCompare 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)

Countries

Canada

Contacts

Primary ContactSuhail Sami Jouni, BSc, PharmD, MSc
suhail.sami.jouni.chum@ssss.gouv.qc.ca514-890-8000
Backup ContactThierry Nader, PharmD, MSc candidate
thierry.nader.chum@ssss.gouv.qc.ca514-890-8000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026