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Analgesic
Acetaminophen for Small Bowel Obstruction
Phase 4
Waitlist Available
Led By Tatjana Gavrancic, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 days
Awards & highlights
Study Summary
This trial compares the effectiveness of Acetaminophen to Opioids in relieving pain from Small Bowel Obstruction.
Who is the study for?
This trial is for patients with abdominal pain due to small bowel obstruction, who can't eat by mouth and have a confirmed diagnosis via imaging. They must be able to consent or have someone who can. It's not for those with substance abuse history, severe kidney issues, acetaminophen allergy, liver failure, current intoxication or on chronic opioids.Check my eligibility
What is being tested?
The study tests IV Acetaminophen as a pain reliever against standard opioid care in patients hospitalized for small bowel obstruction. The goal is to see if it's an effective alternative for managing pain without the usual opioid-related side effects.See study design
What are the potential side effects?
While generally considered safe at prescribed doses, IV Acetaminophen may cause potential side effects such as allergic reactions, skin rash, headache or mild gastrointestinal symptoms. Serious side effects are rare but include liver damage.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Length of hospital stay
Pain Scores
Resolution of small bowel obstruction
Secondary outcome measures
Allergic reaction to acetaminophen
Bowel Perforation
Death
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: IV Acetaminophen GroupExperimental Treatment1 Intervention
Subjects presented to emergency department (ED) and diagnosed with small bowel obstruction which receive IV acetaminophen
Group II: Usual Care GroupActive Control1 Intervention
Subjects presented to emergency department (ED) and diagnosed with small bowel obstruction will receive intravenous opioids per their provider's choice as standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetaminophen
2017
Completed Phase 4
~2030
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,205 Previous Clinical Trials
3,766,772 Total Patients Enrolled
Tatjana Gavrancic, MDPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of drug or alcohol abuse.You are allergic to acetaminophen.You have had a liver transplant.
Research Study Groups:
This trial has the following groups:- Group 1: IV Acetaminophen Group
- Group 2: Usual Care Group
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this investigation now open to applicants?
"Clinicaltrials.gov discloses that this clinical trial, initially posted on July 1st 2023, is not currently accepting new enrollees. Nonetheless, there are 13 other medical trials recruiting participants at present."
Answered by AI
Has the FDA endorsed intravenous acetaminophen as a safe treatment?
"IV Acetaminophen Group was granted a score of 3 due to its status as an approved medication in this Phase 4 trial."
Answered by AI
To what purpose is this experiment ultimately striving?
"This 3-day trial aims to assess Pain Scores. Secondary objectives are tracking the Number of subjects who experience a Bowel Perforation, require surgical intervention for Small Bowel Obstruction treatment, and have an Allergic reaction to Acetaminophen."
Answered by AI
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