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NCT Number: NCT06498713

Patient Controlled Administration of Liquid Acetaminophen

This is a proof of concept pilot study investigating the feasibility and acceptability of patient controlled oral medication administration, using the commonly used and low risk medication in the hospital, oral acetaminophen.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Yale New Haven Hospital at St. Raphael's Campus

New Haven, Connecticut, 06520, United States

Location status: Recruiting

About this study

The primary objective of this prospective pilot study is to determine the feasibility of patient-controlled administration of liquid oral acetaminophen using recruitment rate and adherence to the study protocol rate as surrogate markers. Investigators hypothesize that patients will accept the new concept of self-controlled oral administration of liquid acetaminophen, with more than 50% patient enrollment rate and less than 20% withdrawal rate from the study group to the traditional nurse-administered acetaminophen pills.

The secondary objective of this study is to determine the preliminary efficacy of patient-controlled delivery of oral acetaminophen administration.

If the medication is spilled or otherwise not dispensed correctly, the patients will be instructed to report this instantly to the nurse. The nurse will document and provide a replacement.

All study participants have the option to call the nurse for assistance with break through pain. In addition, there is a call button to call for help with any other needs or discomfort.

All other medications, such as NSAIDs or oral opioids, will be administered as prescribed.

Participants will have to fill out a paper questionnaire and keep a pain diary, and nurses will have to fill out a questionnaire.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants

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

Nurses

  • The nurse who will administer acetaminophen to a study patient.

Exclusion criteria

Participants

  • Pregnant patient
  • Patients that cannot swallow pills or cannot take liquid (for example due to risk of aspiration)
  • Emergency surgery
  • Chronic pain
  • On home opioids, any other pain modulating medications including benzodiazepine, Neurontin, ketamine.
  • Past medical or social history of substance abuse disorder, including ethanol misuse disorder, marijuana misuse disorder
  • History of any psychiatric disorders including anxiety, depression, any cognitive dysfunction
  • Any patients who cannot provide informed consents on their own (those who would need Legally Authorized Representatives (LARs) or surrogates)
  • Liver dysfunction limiting amount of safe oral acetaminophen
  • baseline hyperbilirubinemia (ex: chronic liver disease, Gilbert's)
  • patients unable to take PO
  • Patients with neurologic, neuromuscular, or movement disorders unable to drink from a cup.

Nurses

  • any nurse who is not involved in the direct care of a study patient, or who is not comfortable with setting up the PCA pump.

Treatment and study plan

Acetaminophen 650 mg Oral Tablet

Drug

650 mg pills

Other names: Tylenol

Acetaminophen 650mg Liquid

Drug

650 mg liquid

Other names: Tylenol

CADD pump

Device

Primed and programmed to delivery 650 mg liquid acetaminophen into a medication cup every 4 hours as needed.

Primary outcomes

  1. Participant enrollment rate

    Time frame: up to 12 months

    The percentage of participants that enroll

  2. Participant adherence to the study protocol

    Time frame: up to 12 months

    Percentage of participants that withdraw from treatment group, i.e. switch from patient controlled liquid group to the nurse-administered pill control group

  3. Nurse Questionnaire

    Time frame: Study day 0, 1, 2 and 3

    Nurse ranking of patient controlled liquid oral acetaminophen vs. nurse-administered pill acetaminophen. (Mean score, Total Scale of 0-10: 0: much worse; 5:same; 10: much better)

Secondary outcomes

  1. Mean daily acetaminophen consumption

    Time frame: 12 months

    Mean daily acetaminophen consumption in milligrams collected using the electronic medical record

  2. Mean Pain score

    Time frame: 12 months

    Participants will be asked via Pain Diary to rate their pain using numeric pain scores from 0 to 10, 0 as no pain, 10 is the worst possible.

  3. Mean time to medication delivery

    Time frame: 12 months

    Medication delivery: Mean time in minutes from the time when pain medication requested by the participant to the time pain medication is delivered

Study contacts

Contact information is provided by the study sponsor or research team.

Jinlei Li, MD, PhD

CONTACT

[email protected]

475-434-4038

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

Patient Controlled Self-Administration of Oral Liquid Medication: Acetaminophen Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 12, 2024
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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