Small Bowel Obstruction Clinical Trial
Official title:
A Randomized Study Comparing Intravenous (IV) Acetaminophen to Usual Care for Pain Management for Small Bowel Obstruction - Feasibility Study
Verified date | April 2024 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 12 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic Florida | Jacksonville | Florida |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Resolution of small bowel obstruction | Days until small bowel obstruction resolution, measured by admission date to date that diet was placed | 3 days | |
Primary | 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 | |
Primary | Length of hospital stay | Measured by days from admission day to discharge day | 3 days | |
Secondary | Death | Number of subject deaths | 3 days | |
Secondary | Bowel Perforation | Number of subject to experience a bowel perforation | 3 days | |
Secondary | Surgery | Number of subjects to require surgical intervention for small bowel obstruction treatment | 3 days | |
Secondary | Allergic reaction to acetaminophen | Number of subjects to experience an allergic reaction to acetaminophen | 3 days |
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