A Study of Intravenous Acetaminophen for Small Bowel Obstruction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acetaminophen.
- Who it may be relevant to
- Registry conditions: Small Bowel Obstruction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Study Comparing Intravenous (IV) Acetaminophen to Usual Care for Pain Management for Small Bowel Obstruction - Feasibility Study
Overview
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.
Interventions
- Drug Acetaminophen
1000mg intravenous every 6 hours on day 1 and day 2. 1000mg intravenous every 8 hours on day 3 as needed.
Primary outcome measures
- Resolution of small bowel obstruction [Time frame: 3 days]
- Pain Scores [Time frame: 3 days]
- Length of hospital stay [Time frame: 3 days]
Secondary outcome measures (4)
- Death [Time frame: 3 days]
- Bowel Perforation [Time frame: 3 days]
- Surgery [Time frame: 3 days]
- Allergic reaction to acetaminophen [Time frame: 3 days]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Mayo Clinic Florida — Jacksonville
Identifiers
NCT: NCT05878015 · 23-000547