Acetaminophen for Small Bowel Obstruction

Overseen By Torsak Vimoktayon

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Mayo Clinic

Must not be taking: Opioids

Disqualifiers: Liver failure, Substance abuse, Pregnancy, 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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 3 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether IV acetaminophen (also known as paracetamol or Tylenol) can serve as an alternative to opioids for pain relief in patients with a small bowel obstruction. The goal is to determine if acetaminophen manages pain as effectively as the usual opioid treatment. Participants must have a diagnosis of small bowel obstruction and experience abdominal pain upon admission. As a Phase 4 trial, this research aims to understand how this already FDA-approved and effective treatment can benefit 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, but you cannot participate if you are on chronic opioid therapy.

What is the safety track record for Acetaminophen?

Research shows that IV acetaminophen is generally safe for people and well-tolerated for pain relief. A health cost analysis compared IV to oral acetaminophen for post-surgery pain, suggesting its safety in various situations.

Few reports of serious side effects exist with IV acetaminophen. Most people experience only mild side effects, such as nausea or headaches. The FDA's approval of this treatment for pain in other conditions indicates a good safety record.

Overall, the safety data supports the careful use of IV acetaminophen for managing pain in small bowel obstruction cases. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard of care for small bowel obstruction, which typically involves intravenous opioids to manage pain, the treatment under investigation uses IV acetaminophen. Researchers are excited about this approach because acetaminophen offers pain relief without the risk of opioid-related side effects and dependency issues. Additionally, IV acetaminophen has a different mechanism of action, targeting pain by inhibiting prostaglandin synthesis, which can make it a safer alternative for patients.

What evidence suggests that IV Acetaminophen might be an effective treatment for small bowel obstruction?

Research has shown that acetaminophen effectively relieves mild-to-moderate pain and manages pain with fewer side effects than opioids. In this trial, participants in the IV Acetaminophen Group will receive acetaminophen through an IV, potentially offering a promising alternative to opioids for managing pain in small bowel obstruction. Meanwhile, the Usual Care Group will receive intravenous opioids as standard care. Although acetaminophen is not new, this trial examines its effectiveness and safety in this specific situation. ^{1 2 3 4 6}

Who Is on the Research Team?

Tatjana Gavrancic, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for patients with abdominal pain due to small bowel obstruction, who can't eat by mouth and have a confirmed diagnosis via imaging. They must be able to consent or have someone who can. It's not for those with substance abuse history, severe kidney issues, acetaminophen allergy, liver failure, current intoxication or on chronic opioids.

Inclusion Criteria

Abdominal pain on admission

Nothing per mouth diet

Small bowel obstruction diagnosed by radiographic study

Exclusion Criteria

You have a history of drug or alcohol abuse.

Creatinine clearance < 30 (or Creatinine level > 2)

You are allergic to acetaminophen.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive either IV acetaminophen or usual care with opioids for pain management

3 days

Daily monitoring (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment via medical records

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Acetaminophen

Trial Overview The study tests IV Acetaminophen as a pain reliever against standard opioid care in patients hospitalized for small bowel obstruction. The goal is to see if it's an effective alternative for managing pain without the usual opioid-related side effects.

How Is the Trial Designed?

Group I: IV Acetaminophen Group Experimental Treatment 1 Intervention

Subjects presented to emergency department (ED) and diagnosed with small bowel obstruction which receive IV acetaminophen

Group II: Usual Care Group Active Control 1 Intervention

Subjects presented to emergency department (ED) and diagnosed with small bowel obstruction will receive intravenous opioids per their provider's choice as standard of care.

Acetaminophen is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Tylenol for:

• Pain relief
• Fever reduction

Approved in European Union as Paracetamol for:

• Pain relief
• Fever reduction

Approved in Canada as Tylenol for:

• Pain relief
• Fever reduction

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

Acetaminophen is a well-tolerated first-line pain reliever and fever reducer in children, commonly used in pediatric care with minimal side effects.

The introduction of intravenous acetaminophen in the U.S. provides an important alternative for pediatric patients near end-of-life who may have difficulty with oral intake or rectal administration, enhancing pain management options in palliative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of intravenous acetaminophen (paracetamol) in a pediatric patient at the end of life: case report. Marks, AD., Keefer, P., Saul, D.[2013]

Tramadol/paracetamol (TRM+P) has the highest reporting rate of adverse drug reactions (ADRs) among the three weak opioid analgesics studied, with a rate of 44.5 per 100,000 person-years, compared to 24.9 for dextropropoxyphene/paracetamol (DXP+P) and 12.5 for codeine/paracetamol (COD+P).

Dextropropoxyphene/paracetamol (DXP+P) is associated with a higher frequency of hepatobiliary ADRs and a worse safety profile compared to codeine/paracetamol (COD+P), despite having a lower overall reporting rate of ADRs than tramadol/paracetamol.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting rate of adverse drug reactions to the French pharmacovigilance system with three step 2 analgesic drugs: dextropropoxyphene, tramadol and codeine (in combination with paracetamol). Tavassoli, N., Lapeyre-Mestre, M., Sommet, A., et al.[2021]

Paracetamol and codeine are identified as safe alternative pain relievers for patients who cannot tolerate traditional analgesics.

Recent selective COX-2 inhibitors, including nimesulide, meloxicam, and rofecoxib, are also considered safe options for pain management in these patients, particularly in the context of their recent marketing in Turkey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of nimesulide, meloxicam and rofecoxib as alternative analgesics. Karakaya, G., Kalyoncu, AF.[2018]

A study involving 251 children aged 2-12 years showed that a fixed-dose combination of paracetamol and ibuprofen for pain management after tonsillectomy was well tolerated and effective, with no significant differences in pain scores or rescue medication use between two different dosing groups.

The combination analgesic demonstrated a good safety profile, with the most common side effects being mild (nausea and vomiting), and a low incidence of postoperative bleeding at 4.4%, indicating it can be a reliable option for managing pain at home.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesic effectiveness, pharmacokinetics, and safety of a paracetamol/ibuprofen fixed-dose combination in children undergoing adenotonsillectomy: A randomized, single-blind, parallel group trial. Playne, R., Anderson, BJ., Frampton, C., et al.[2019]

In a study of 180 children undergoing adenoidectomy, oral naproxen (10 mg/kg) significantly reduced the need for rescue analgesics compared to paracetamol (20 mg/kg) and placebo, indicating its efficacy in managing post-operative pain.

The addition of pethidine (1 mg/kg) further decreased the need for rescue fentanyl by 30% and halved the number of doses required, but it also doubled the incidence of post-operative nausea and vomiting (PONV), highlighting a trade-off between pain management and side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral naproxen but not oral paracetamol reduces the need for rescue analgesic after adenoidectomy in children. Korpela, R., Silvola, J., Laakso, E., et al.[2013]

The new fast-dissolving acetaminophen tablet formulation (FD-APAP) disintegrates significantly faster than standard acetaminophen tablets, with a mean disintegration time of 12.9 minutes compared to 69.6 minutes (P < 0.0001).

FD-APAP also shows a quicker absorption rate, with a median time to peak concentration (Tmax) of 0.50 hours versus 0.67 hours for standard acetaminophen (P < 0.01), potentially leading to improved pain relief outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of a novel fast-dissolving acetaminophen tablet formulation (FD-APAP) and standard acetaminophen tablets using gamma scintigraphy and pharmacokinetic studies. Wilson, CG., Clarke, CP., Starkey, YY., et al.[2022]

Citations

1. shmabstracts.org shmabstracts.org/abstract/a-randomized-double-blind-placebo-controlled-clinical-trial-of-intravenous-acetaminophen-use-for-pain-management-in-small-bowel-obstruction-interim-analysis-of-feasibility-and-outcomes/

INTERIM ANALYSIS OF FEASIBILITY AND OUTCOMES This randomized controlled trial (RCT) evaluates the efficacy of IV acetaminophen for pain management in SBO patients, focusing on its impact on ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9666016/

Small Bowel Obstruction Conservatively Managed in ... The patient received the following medications while at home: acetaminophen suppositories 325 mg, D5W and NaCl 0.45% with KCl 20 mEq/L infusion, ...

3. mayo.edu mayo.edu/research/clinical-trials/cls-20548880

A Study of Intravenous Acetaminophen for Small Bowel ... The purpose of this study is to assess the effectiveness of IV Acetaminophen in decreasing pain as measured by a pain scale of subjective pain reported by ...

4. withpower.com withpower.com/trial/phase-4-intestinal-obstruction-6-2023-1e9a7

Acetaminophen for Small Bowel Obstruction What data supports the effectiveness of the drug acetaminophen for small bowel obstruction? Acetaminophen is widely used to relieve mild-to-moderate pain ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10576540/

Complex Surgical Intervention for Small Bowel Obstruction ... Despite taking 1000 mg of acetaminophen, the pain did not improve. The patient also reported experiencing associated symptoms of nausea, ...

6. mallinckrodt.com mallinckrodt.com/about/news-and-media/news-detail/?id=8351

Health Economic Data on OFIRMEV ® (Acetaminophen) ... A retrospective, claims-based health economic analysis on use of intravenous (IV) acetaminophen versus oral acetaminophen for managing post-operative pain.