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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV Acetaminophen Group | Experimental | Subjects presented to emergency department (ED) and diagnosed with small bowel obstruction which receive IV 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen | Drug | 1000mg intravenous every 6 hours on day 1 and day 2. 1000mg intravenous every 8 hours on day 3 as needed. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Death | Number of subject deaths | 3 days |
| Bowel Perforation | Number of subject to experience a bowel perforation | 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tatjana Gavrancic, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | United States |
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| Label | URL |
|---|---|
| A Study of Intravenous Acetaminophen for Small Bowel Obstruction | View source |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| 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 |
| Aniline Compounds |
| D000588 | Amines |