A Study of Intravenous Acetaminophen for Small Bowel Obstruction

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Small Bowel Obstruction
• Intervention / Treatment: Drug: Acetaminophen

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IV Acetaminophen Group; Subjects presented to emergency department (ED) and diagnosed with small bowel obstruction which receive IV acetaminophen	Drug: Acetaminophen; 1000mg intravenous every 6 hours on day 1 and day 2. 1000mg intravenous every 8 hours on day 3 as needed.; Other Names: Tylenol
No Intervention: Usual Care Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resolution of small bowel obstruction	Days until small bowel obstruction resolution, measured by admission date to date that diet was placed	3 days
Pain Scores	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 days
Length of hospital stay	Measured by days from admission day to discharge day	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	Number of subject deaths	3 days
Bowel Perforation	Number of subject to experience a bowel perforation	3 days
Surgery	Number of subjects to require surgical intervention for small bowel obstruction treatment	3 days
Allergic reaction to acetaminophen	Number of subjects to experience an allergic reaction to acetaminophen	3 days

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Tatjana Gavrancic, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• A Study of Intravenous Acetaminophen for Small Bowel Obstruction

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: May 18, 2023
• First Submitted That Met QC Criteria: May 18, 2023
• First Posted (Actual): May 26, 2023

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Obstruction; Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Acetaminophen
• Other Study ID Numbers: 23-000547

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No