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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05878015
Other study ID # 23-000547
Secondary ID
Status Enrolling by invitation
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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