Post Operative AnalgesiaPhase 4ACETAPOPNCT06923540
Intravenous Acetaminophen to Reduce Post-operative Opioid Consumption
A Phase 4 study testing IV Acetaminophen in people with Post Operative Analgesia and Opioid Consumption, Postoperative, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Analgesia, Opioid Consumption, Postoperative, Acetaminophen
- What is being tested?
- IV Acetaminophen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteCanada
- Study dates
- 28 Apr 2025to 15 Aug 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Suhail Sami Jouni, BSc, PharmD, MSc contact
Thierry Nader, PharmD, MSc candidate contact
Canada1 site
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0A9
Suhail Sami Vandenbroucke-Menu, MD, 514-890-8000 ext. 36163, suhail.sami.jouni.chum@ssss.gouv.qc.ca
About this study
Official title: Evaluating the Impact of IV Acetaminophen on Opioid Consumption in the Postoperative Period in Patients Undergoing Abdominal Surgery
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.
Read the 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?
- Conditions
- Post Operative Analgesia, Opioid Consumption, Postoperative, Acetaminophen, Abdominal Surgeries, Post Operative Bowel Dysfunction, Post Operative Nausea and Vomiting
- Being tested
- IV Acetaminophen
- 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
- Medical subject headings
- Vomiting, Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV AcetaminophenDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Pre-intervention arm (standard protocol containing PO or IR Acetaminophen) | No intervention | This arm will receive the protocol currently used at the CHUM surgical units for post operative pain management, which includes PO or IR acetaminophen. |
| Post-intervention arm (modified protocol containing IV Acetaminophen) | Active comparator | 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. Receives: Drug: IV Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 72 hours
Secondary outcomes (1)
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.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start28 Apr 2025 (estimated)
- Primary completion15 Aug 2025 (estimated)
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative AnalgesiaStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Franck Vandenbroucke-Menu, MD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06923540
- Sponsor's protocol ID
- 2025-12623
- Other IDs
- 2025
- Acronym
- ACETAPOP
- Status last verified
- Apr 2025
- First submitted
- 13 Mar 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of IV Acetaminophen on Opioid Consumption in the Postoperative Period in Patients Undergoing Abdominal Surgery
- ClinicalTrials.gov ID
- NCT06923540
- Acronym / sponsor ID
- ACETAPOP / 2025-12623
- Conditions
- Post Operative Analgesia, Opioid Consumption, Postoperative, Acetaminophen, Abdominal Surgeries, Post Operative Bowel Dysfunction, Post Operative Nausea and Vomiting
- Keywords
- IV acetaminophen, intravenous acetaminophen, acetaminophen, post operative analgesia, nil per os, npo, post operative pain, opioid consumption
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 28 Apr 2025 (estimated)
- Primary completion
- 15 Aug 2025 (estimated)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 11 Apr 2025 (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.
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?
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pre-intervention arm (standard protocol containing PO or IR Acetaminophen) | No intervention | –This arm will receive the protocol currently used at the CHUM surgical units for post operative pain management, which includes PO or IR acetaminophen. |
| Post-intervention arm (modified protocol containing IV Acetaminophen) | Active comparator | Drug: IV AcetaminophenThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| IV AcetaminophenThis 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. | Drug | Post-intervention arm (modified protocol containing IV Acetaminophen) |
Primary outcome
Opioid consumption in oral morphine milligram equivalents (MME)
Time frame: 72 hours
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).
1 secondary outcome
Opioid consumption (converted to MME) at 24 and 48 hours postoperatively
Time frame: 48 hours
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 11 Apr 2025.
- 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.
Suhail Sami Jouni, BSc, PharmD, MSc contact
Thierry Nader, PharmD, MSc candidate contact
Franck Vandenbroucke-Menu, MD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
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 testing IV Acetaminophen in people with Post Operative Analgesia and Opioid Consumption, Postoperative, run by Centre hospitalier de l'Université de Montréal (CHUM) 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 5 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: opening soon, as of the sponsor's last update on 11 Apr 2025. 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 Suhail Sami Jouni, BSc, PharmD, MSc (514-890-8000 ext. 36163, suhail.sami.jouni.chum@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid consumption in oral morphine milligram equivalents (MME) (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2025.