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NCT05878015 | ENROLLING BY INVITATION | Small Bowel Obstruction

A Study of Intravenous Acetaminophen for Small Bowel Obstruction
Sponsor:

Mayo Clinic

Information provided by (Responsible Party):

Tatjana Gavrancic

Brief Summary:

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.

Condition or disease

Small Bowel Obstruction

Intervention/treatment

Acetaminophen

Phase

PHASE4

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 18 participants
Masking : SINGLE
Primary Purpose : SUPPORTIVE_CARE
Official Title : A Randomized Study Comparing Intravenous (IV) Acetaminophen to Usual Care for Pain Management for Small Bowel Obstruction - Feasibility Study
Actual Study Start Date : 2023-10-11
Estimated Primary Completion Date : 2026-12
Estimated Study Completion Date : 2026-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
A Study of Intravenous Acetaminophen for Small Bowel Obstruction

Location Details

NCT05878015

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How to Participate

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Locations

Not yet recruiting

United States, Florida

Mayo Clinic Florida

Jacksonville, Florida, United States, 32224