A Study of Intravenous Acetaminophen for Small Bowel Obstruction

NCT05878015 | Enrolling By Invitation Phase 4 DMC FDA Drug

• 1 other identifier: 23-000547
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Small Bowel Obstruction

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Death

  3 days

• Bowel Perforation

  3 days

• Surgery

  3 days

• Allergic reaction to acetaminophen

  3 days

Study Arms (2)

IV Acetaminophen Group

EXPERIMENTAL

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

Drug: Acetaminophen

Usual Care Group

NO 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.

Interventions

Acetaminophen DRUG

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

Also known as: Tylenol

IV Acetaminophen Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• A Study of Intravenous Acetaminophen for Small Bowel Obstruction

MeSH Terms

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Tatjana Gavrancic, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: May 26, 2023
• Study Start: October 11, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)