A Study of Intravenous Acetaminophen for Small Bowel Obstruction

Small Bowel Obstruction Clinical Trial

Official title:

A Randomized Study Comparing Intravenous (IV) Acetaminophen to Usual Care for Pain Management for Small Bowel Obstruction - Feasibility Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05878015
• Other study ID #: 23-000547
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: October 11, 2023
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 12
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intestinal Obstruction
• Small Bowel Obstruction

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of small bowel obstruction	Days until small bowel obstruction resolution, measured by admission date to date that diet was placed	3 days
Primary	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).	3 days
Primary	Length of hospital stay	Measured by days from admission day to discharge day	3 days
Secondary	Death	Number of subject deaths	3 days
Secondary	Bowel Perforation	Number of subject to experience a bowel perforation	3 days
Secondary	Surgery	Number of subjects to require surgical intervention for small bowel obstruction treatment	3 days
Secondary	Allergic reaction to acetaminophen	Number of subjects to experience an allergic reaction to acetaminophen	3 days