Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
NCT Number: NCT05878015
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
Jacksonville, Florida, 32224, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1000mg intravenous every 6 hours on day 1 and day 2. 1000mg intravenous every 8 hours on day 3 as needed.
Other names: Tylenol
Time frame: 3 days
Days until small bowel obstruction resolution, measured by admission date to date that diet was placed
Time frame: 3 days
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
Measured by days from admission day to discharge day
Time frame: 3 days
Number of subject deaths
Time frame: 3 days
Number of subject to experience a bowel perforation
Time frame: 3 days
Number of subjects to require surgical intervention for small bowel obstruction treatment
Time frame: 3 days
Number of subjects to experience an allergic reaction to acetaminophen
Mayo Clinic
Other
A Randomized Study Comparing Intravenous (IV) Acetaminophen to Usual Care for Pain Management for Small Bowel Obstruction - Feasibility Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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