A Study of Intravenous Acetaminophen for Small Bowel Obstruction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-11

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Small Bowel Obstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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IV Acetaminophen Group

Subjects presented to emergency department (ED) and diagnosed with small bowel obstruction which receive IV acetaminophen

Group Type EXPERIMENTAL

Acetaminophen

Intervention Type DRUG

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

Usual Care Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Acetaminophen

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

Intervention Type DRUG

Other Intervention Names

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Tylenol

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No