Intravenous Acetaminophen for Pain Management

(ACETAPOP Trial)

Not yet recruiting at 1 trial location

Overseen By Thierry 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 Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 72 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of intravenous (IV) acetaminophen for managing post-surgical pain. Researchers aim to determine if IV acetaminophen can reduce the need for opioids, which often cause side effects like nausea and dizziness. The trial includes two groups: one will continue with the usual acetaminophen tablets or suppositories, while the other will use the IV form. It suits those who have undergone abdominal or elective surgery at CHUM and cannot take oral medications immediately after surgery. As a Phase 4 trial, this research seeks to understand how this already FDA-approved treatment benefits more patients.

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 is the safety track record for IV Acetaminophen?

Research has shown that IV acetaminophen is generally safe for people. One study found it reduced the need for morphine for pain relief after surgery. This reduction is important because it lowers the risk of side effects like nausea, dizziness, and addiction.

IV acetaminophen also decreased the need for strong painkillers in the first few hours post-surgery, which is significant for those concerned about opioid use. Although its pain relief may diminish over time, it remains crucial for early pain management.

Overall, IV acetaminophen is considered safe and is used in many countries. It is already recommended in certain situations in Quebec, Canada. These findings suggest it is a promising option for managing post-surgery pain while reducing the need for stronger painkillers. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard protocol for post-operative pain management that involves oral (PO) or rectal (IR) acetaminophen, the treatment under study uses intravenous (IV) acetaminophen. Researchers are excited about this approach because IV administration allows for faster absorption and potentially quicker pain relief, which is crucial after surgery. This method might also benefit patients who have difficulty swallowing pills or need immediate pain control. By exploring IV acetaminophen, researchers hope to improve pain management outcomes and enhance patient comfort and recovery.

What evidence suggests that IV acetaminophen could be an effective treatment for pain management?

Research has shown that administering acetaminophen through an IV can effectively manage post-surgery pain. Studies have found that IV acetaminophen can shorten hospital stays and speed up recovery. It reduces pain and decreases the need for opioids, which are strong painkillers that may cause side effects like nausea and dizziness. In this trial, participants in the post-intervention arm will receive a modified protocol that includes IV acetaminophen, while those in the pre-intervention arm will follow the standard protocol with oral or suppository acetaminophen. Although many countries widely use IV acetaminophen, limited data directly compare it to the pill or suppository forms. However, it is expected to be particularly beneficial for patients unable to take medication by mouth or as a suppository. ^{1 6 7 8 9}

Who Is on the Research Team?

Franck Vandenbroucke-Menu, MD

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

Hypersensitivity to acetaminophen or an excipient in the administered formulations

Use of illicit recreational substances

Prior participation in this study

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Pre-intervention arm (standard protocol containing PO or IR Acetaminophen) Active Control 1 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 Control 1 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.

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12019136/

Effectiveness of oral vs intravenous acetaminophen on pain ... These results indicate that intravenous injection of acetaminophen can effectively shorten hospital stay and accelerate postoperative recovery ...

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK538274/

Intravenous Acetaminophen for the Management of ... - NCBI The percentage of patients achieving at least 50% pain relief at six hours showed a decrease in analgesic effects compared to values at four ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2214031X18300846#!

Effectiveness of intravenous acetaminophen for ... IV APAP was used in 17.7% (n = 11,949) of patients with an increasing utilization trend. Most patients received only one dose on the day of surgery (69.5%; n = ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02643394

Efficacy of Oral vs. Intravenous Acetaminophen The comparative efficacy of intravenous (IV) to oral (PO-'per os') acetaminophen in the management of postoperative pain is understudied and largely unknown.

5. journals.lww.com journals.lww.com/md-journal/fulltext/2016/11010/effectiveness_of_postoperative_intravenous.86.aspx

Effectiveness of postoperative intravenous acetaminophen... The aim of this study was to investigate the efficacy of postoperative scheduled intravenous acetaminophen to reduce the opioid use and enhance recovery ...

6. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2022.909572/full

Efficacy and safety of intravenous acetaminophen (2 g/day) ... In the study reported by Delbos and Boccard (1995), intravenous acetaminophen has demonstrated a morphine-sparing effect with 8.6 mg (20.0%) in postoperative ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1091255X23064880

IV Acetaminophen Results in Lower Hospital Costs and ... Using IV acetaminophen for postoperative pain management produced notable indirect cost savings and reduced ED visits in the first 30 days postoperatively.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6476265/

The role of intravenous acetaminophen in post‐operative ... This study demonstrates that intravenous acetaminophen may play a role in reducing the total narcotic requirement in the first 8 hours after surgery.

9. nature.com nature.com/articles/s41598-021-84866-7

Postoperative around-the-clock administration of ... The results suggest that ATC administration of IV acetaminophen was more effective than PRN administration in reducing pain intensity and ...