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Duration: 72 hours

140 Participants Needed

Intravenous Acetaminophen for Pain Management
(ACETAPOP Trial)

Overseen ByThierry Nader, PharmD, MSc candidate

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Must not be taking: Long-acting opioids

Disqualifiers: Hepatic insufficiency, Pregnancy, Opioid use disorder, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using long-acting opioids, you must not have taken them within seven days before surgery to participate.

What data supports the effectiveness of the drug intravenous acetaminophen for pain management?

Research shows that intravenous acetaminophen can effectively reduce the need for opioids (strong painkillers) after surgery, making it a safer option for managing pain. It has been used successfully in Europe for over 20 years and is recognized for its safety and ability to relieve pain and reduce fever.¹ ² ³ ⁴ ⁵

Is intravenous acetaminophen safe for humans?

Intravenous acetaminophen is generally considered safe for humans, with rare cases of significant adverse reactions like low blood pressure and liver issues. It has been used safely in both adults and children for pain and fever management, although caution is advised with repeated high doses due to potential liver toxicity.¹ ⁵ ⁶ ⁷ ⁸

How is intravenous acetaminophen different from other pain management drugs?

Intravenous acetaminophen is unique because it is administered directly into the bloodstream, which can provide faster pain relief compared to oral forms. It is also used to reduce the need for opioids, which are stronger painkillers with more side effects, making it a safer option for managing pain, especially after surgery.¹ ² ³ ⁵ ⁹

What is the purpose of this trial?

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.

Research Team

Franck Vandenbroucke-Menu, MD

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria

This trial is for adults in Canada who are undergoing abdominal surgery and may experience post-operative pain, nausea, or vomiting. Participants should not be able to take acetaminophen orally or rectally. The study excludes those with specific conditions that the provided information does not detail.

Inclusion Criteria

I have had surgery on my abdomen.

I have had surgery by choice.

I am hospitalized in a specific surgery unit at CHUM.

See 1 more

Exclusion Criteria

Hypersensitivity to acetaminophen or an excipient in the administered formulations

Use of illicit recreational substances

Prior participation in this study

See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the standard protocol with PO or IR acetaminophen or the modified protocol with IV acetaminophen for postoperative pain management

72 hours

Continuous monitoring during hospital stay

Follow-up

Participants are monitored for opioid consumption, pain levels, nausea, constipation, and functionality post-treatment

72 hours

Extended Follow-up

Participants' length of hospital stay is monitored from the end of surgery until discharge

Up to 6 months

Treatment Details

Interventions

IV Acetaminophen

Trial Overview The trial is testing intravenous (IV) acetaminophen's effectiveness in reducing opioid consumption after surgery. It aims to provide clear data on whether IV acetaminophen can control pain effectively compared to oral or rectal forms.

Participant Groups

2Treatment groups

Active Control

Group I: Pre-intervention arm (standard protocol containing PO or IR Acetaminophen)Active Control1 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.

Group II: Post-intervention arm (modified protocol containing IV Acetaminophen)Active Control1 Intervention

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.

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Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Findings from Research

Intravenous (IV) paracetamol is widely used in hospitals for managing fever and pain, and significant adverse reactions are very rare.

However, there is a case report of severe hypotension and cardiac arrest associated with IV paracetamol infusion, highlighting the need for careful monitoring during its administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paracetamol infusion-related severe hypotension and cardiac arrest in a child.Yaman, A., Demir, B., Belen, FB., et al.[2018]

A study involving 213 adult inpatients found that intravenous (IV) acetaminophen, administered in doses of either 1,000mg every 6 hours or 650mg every 4 hours for up to 5 days, was safe and well tolerated, with a low incidence of treatment-related adverse events.

Despite a high frequency of adverse events reported due to the patients' comorbidities, only 8% withdrew from the study because of these events, and no significant hepatic issues were linked to IV acetaminophen, supporting its use as a safe pain management option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of multiple-dose intravenous acetaminophen in adult inpatients.Candiotti, KA., Bergese, SD., Viscusi, ER., et al.[2022]