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A Study of Intravenous Acetaminophen for Small Bowel Obstruction

Primary Purpose

Small Bowel Obstruction

Status
Enrolling by invitation
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Acetaminophen
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Small Bowel Obstruction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

IV Acetaminophen Group

Usual Care Group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Resolution of small bowel obstruction
Days until small bowel obstruction resolution, measured by admission date to date that diet was placed
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).
Length of hospital stay
Measured by days from admission day to discharge day

Secondary Outcome Measures

Death
Number of subject deaths
Bowel Perforation
Number of subject to experience a bowel perforation
Surgery
Number of subjects to require surgical intervention for small bowel obstruction treatment
Allergic reaction to acetaminophen
Number of subjects to experience an allergic reaction to acetaminophen

Full Information

First Posted
May 18, 2023
Last Updated
October 12, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05878015
Brief Title
A Study of Intravenous Acetaminophen for Small Bowel Obstruction
Official Title
A Randomized Study Comparing Intravenous (IV) Acetaminophen to Usual Care for Pain Management for Small Bowel Obstruction - Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 11, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Bowel Obstruction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IV Acetaminophen Group
Arm Type
Experimental
Arm Description
Subjects presented to emergency department (ED) and diagnosed with small bowel obstruction which receive IV acetaminophen
Arm Title
Usual Care Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
Tylenol
Intervention Description
1000mg intravenous every 6 hours on day 1 and day 2. 1000mg intravenous every 8 hours on day 3 as needed.
Primary Outcome Measure Information:
Title
Resolution of small bowel obstruction
Description
Days until small bowel obstruction resolution, measured by admission date to date that diet was placed
Time Frame
3 days
Title
Pain Scores
Description
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).
Time Frame
3 days
Title
Length of hospital stay
Description
Measured by days from admission day to discharge day
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Death
Description
Number of subject deaths
Time Frame
3 days
Title
Bowel Perforation
Description
Number of subject to experience a bowel perforation
Time Frame
3 days
Title
Surgery
Description
Number of subjects to require surgical intervention for small bowel obstruction treatment
Time Frame
3 days
Title
Allergic reaction to acetaminophen
Description
Number of subjects to experience an allergic reaction to acetaminophen
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tatjana Gavrancic, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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A Study of Intravenous Acetaminophen for Small Bowel Obstruction

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