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

18 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to compare IV Acetaminophen for pain control to the usual care with opioids in patients admitted for small bowel obstruction.

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 data supports the effectiveness of the drug acetaminophen for small bowel obstruction?

Acetaminophen is widely used to relieve mild-to-moderate pain and reduce fever, and its use in postsurgical pain management has been shown to decrease opioid usage and subjective pain. However, there is no direct evidence from the provided research specifically supporting its effectiveness for small bowel obstruction. ^{1 2 3 4 5}

Is acetaminophen generally safe for humans?

Acetaminophen (also known as paracetamol) is widely used for pain and fever relief and is generally considered safe with minimal side effects. However, rare cases of skin reactions have been reported. ^{3 6 7 8 9}

How does the drug acetaminophen differ from other treatments for small bowel obstruction?

Acetaminophen is unique for small bowel obstruction as it can be administered via alternative routes like buccal (inside the cheek) or intravenous (IV) when oral administration is not possible, providing flexibility in pain management. ^{1 4 10 11 12}

Research Team

Tatjana Gavrancic, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Oral naproxen but not oral paracetamol reduces the need for rescue analgesic after adenoidectomy in children. [2013]

2. England 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Use of intravenous acetaminophen (paracetamol) in a pediatric patient at the end of life: case report. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Randomized trial of OFIRMEV versus placebo for pain management after laparoscopic sleeve gastrectomy. [2017]

5. England pubmed.ncbi.nlm.nih.gov

Treatment with paracetamol in infants. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Cellulitis-like fixed drug eruption attributed to paracetamol (acetaminophen). [2013]

7. England pubmed.ncbi.nlm.nih.gov

Current perceptions and use of paracetamol in dogs among veterinary surgeons working in the United Kingdom. [2023]

8. England 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). [2021]

9. Singapore pubmed.ncbi.nlm.nih.gov

Safety of nimesulide, meloxicam and rofecoxib as alternative analgesics. [2018]

10. France 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. [2019]

11. New Zealand pubmed.ncbi.nlm.nih.gov

Buccal acetaminophen provides fast analgesia: two randomized clinical trials in healthy volunteers. [2021]

12. New Zealand pubmed.ncbi.nlm.nih.gov

Acetaminophen for analgesia following pyloromyotomy: does the route of administration make a difference? [2020]