Clinical trial NCT05878015: A Study of Intravenous Acetaminophen for Small Bowel Obstruction
Official title: A Randomized Study Comparing Intravenous (IV) Acetaminophen to Usual Care for Pain Management for Small Bowel Obstruction - Feasibility Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Small Bowel Obstruction
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

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.

Primary outcomes:
measure: Resolution of small bowel obstruction
timeFrame: 3 days
measure: Pain Scores
timeFrame: 3 days
measure: Length of hospital stay
timeFrame: 3 days
Secondary outcomes:
measure: Death
timeFrame: 3 days
measure: Bowel Perforation
timeFrame: 3 days
measure: Surgery
timeFrame: 3 days
measure: Allergic reaction to acetaminophen
timeFrame: 3 days
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Tatjana Gavrancic, MD
role: PRINCIPAL_INVESTIGATOR
References: