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Analgesic

Patient-Controlled Acetaminophen for Postoperative Pain

Phase 1

Recruiting

Led By Jinlei Li, MD, PhD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult patients older than 18 years old admitted to SRC for total shoulder and reverse total shoulder arthroplasty

Be older than 18 years old

Must not have

Patients that cannot swallow pills or cannot take liquid (for example due to risk of aspiration)

Liver dysfunction limiting amount of safe oral acetaminophen

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if patients can control when they take their oral acetaminophen medication in the hospital.

Who is the study for?

This trial is for individuals experiencing pain after surgery. Participants must be able to take oral medication and use a patient-controlled pump, but specific inclusion and exclusion criteria are not listed.

What is being tested?

The study explores if patients can manage their postoperative pain by controlling their intake of liquid acetaminophen using a CADD pump versus taking regular acetaminophen tablets.

What are the potential side effects?

Acetaminophen is generally low-risk but may cause side effects like nausea, stomach pain, loss of appetite, itching, rash or headaches when taken in excess.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 and scheduled for shoulder replacement surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot swallow pills or take liquid medication.

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My liver condition limits how much acetaminophen I can safely take.

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I can make my own medical decisions without needing a legal representative.

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I have a long-term high bilirubin level due to liver condition or Gilbert's.

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I cannot take medications by mouth.

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I cannot drink from a cup due to a neurological or movement disorder.

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I am currently taking pain medication, including opioids or others like benzodiazepine.

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I have had emergency surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Nurse Questionnaire

Participant adherence to the study protocol

Participant enrollment rate

Secondary study objectives

Mean Pain score

Mean daily acetaminophen consumption

Mean time to medication delivery

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CADD pump Administered Acetaminophen (Participant Controlled)Experimental Treatment2 Interventions

Participants will receive a CADD pump primed and programmed to deliver 650 mg liquid acetaminophen into a medication cup every 4 hours as needed (PRN).

Group II: Nurse Administered AcetaminophenActive Control1 Intervention

Participants will receive acetaminophen pills 650 mg every 4 hours as needed (PRN) administered by nurse per standard of care

0 / 9Eligibility criteria met