A Study of Intravenous Acetaminophen for Small Bowel Obstruction

Phase 4Enrolling By InvitationNCT05878015

Mayo Clinic18 enrolled

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Small Bowel Obstruction

Interventions

AcetaminophenDRUG

1000mg intravenous every 6 hours on day 1 and day 2. 1000mg intravenous every 8 hours on day 3 as needed.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mayo Clinic Florida

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

Resolution of small bowel obstruction

Days until small bowel obstruction resolution, measured by admission date to date that diet was placed

Time frame: 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).

Time frame: 3 days

Length of hospital stay

Measured by days from admission day to discharge day

Time frame: 3 days

Secondary Outcomes

Death

Number of subject deaths

Time frame: 3 days

Bowel Perforation

Number of subject to experience a bowel perforation

Time frame: 3 days

Surgery

Number of subjects to require surgical intervention for small bowel obstruction treatment

Time frame: 3 days

Allergic reaction to acetaminophen

Number of subjects to experience an allergic reaction to acetaminophen

Time frame: 3 days

Data from ClinicalTrials.gov

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