A Study of Intravenous Acetaminophen for Small Bowel Obstruction

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Small Bowel Obstruction

Intervention / Treatment
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* Drug: Acetaminophen


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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