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Enrolling by Invitation

NCT Number: NCT05878015

A Study of Intravenous Acetaminophen for Small Bowel Obstruction

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.

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

About this study

The primary aim of this study is to assess the feasibility of conducting a randomized trial involving intravenous acetaminophen for pain control compared to usual care with opioids in patients admitted for small bowel obstruction and to summarize pain scores up to 72 hours after treatment. Patients presented and diagnosed with small bowel obstruction (SBO) will be screened for eligibility and will be offered participation in this study. Patients admitted for SBO for medical management with pain on admission will be eligible to participate in study. This will include patients with malignant and nonmalignant SBO. Participants will be randomly assigned into one of two groups, either the Treatment Group which receive IV acetaminophen or the Usual Care Group which will receive intravenous morphine or hydromorphone as needed for pain control. A Nasogastric (NG) tube will be placed when it is indicated, if patient is having significant nausea or vomiting. Pain scores will be followed as usual pain management assessment and reported in the medical record. Once SBO is resolved (usually 3 days after admission), active study participation will end. Participants may be followed via their medical record up to 30 days after discharge.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Small bowel obstruction diagnosed by radiographic study; and
  • Abdominal pain on admission.
  • Nothing per mouth diet.
  • The ability to give appropriate consent or have an appropriate representative available to do so.

Exclusion criteria

  • Known liver failure or cirrhosis.
  • Acetaminophen toxicity on admission.
  • Known acetaminophen allergy.
  • Alcohol intoxication on admission.
  • History of substance abuse.
  • Creatinine clearance < 30 (or Creatinine level > 2).
  • Liver transplant recipients.
  • Ileus on admission.
  • Admitted for surgical intervention for SBO.
  • Admitted for venting Gastric tube placement.
  • On chronic opioid therapy (defined as use of opioid on daily or near daily basis within previous 45 days (both long acting and short acting).
  • Presentation without abdominal pain on admission.
  • Already hospitalized for other reasons and develop SBO while at the hospital.
  • Pregnant women.
  • Unable to provide informed consent.

Treatment and study plan

Acetaminophen

Drug

1000mg intravenous every 6 hours on day 1 and day 2. 1000mg intravenous every 8 hours on day 3 as needed.

Other names: Tylenol

Primary outcomes

  1. Resolution of small bowel obstruction

    Time frame: 3 days

    Days until small bowel obstruction resolution, measured by admission date to date that diet was placed

  2. Pain Scores

    Time frame: 3 days

    Pain is measured by a pain scale of subjective pain reported by patients and measured by nurses and ranges from 0 (no pain) to 10 (worst pain).

  3. Length of hospital stay

    Time frame: 3 days

    Measured by days from admission day to discharge day

Secondary outcomes

  1. Death

    Time frame: 3 days

    Number of subject deaths

  2. Bowel Perforation

    Time frame: 3 days

    Number of subject to experience a bowel perforation

  3. Surgery

    Time frame: 3 days

    Number of subjects to require surgical intervention for small bowel obstruction treatment

  4. Allergic reaction to acetaminophen

    Time frame: 3 days

    Number of subjects to experience an allergic reaction to acetaminophen

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

A Randomized Study Comparing Intravenous (IV) Acetaminophen to Usual Care for Pain Management for Small Bowel Obstruction - Feasibility Study

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
May 26, 2023
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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