Patient Controlled Administration of Liquid Acetaminophen

NCT06498713 | Recruiting Phase 1 FDA Drug FDA Device

• 1 other identifier: 2000037919
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain; Pain, Postoperative

Keywords

Pain Management

Outcome Measures

Primary Outcomes (3)

• Participant enrollment rate

  The percentage of participants that enroll

  up to 12 months

• Participant adherence to the study protocol

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

  up to 12 months

• Nurse Questionnaire

  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)

  Study day 0, 1, 2 and 3

Secondary Outcomes (3)

• Mean daily acetaminophen consumption

  12 months

• Mean Pain score

  12 months

• Mean time to medication delivery

  12 months

Study Arms (2)

Nurse Administered Acetaminophen

ACTIVE COMPARATOR

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

Drug: Acetaminophen 650 mg Oral Tablet

CADD pump Administered Acetaminophen (Participant Controlled)

EXPERIMENTAL

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).

Drug: Acetaminophen 650mg Liquid; Device: CADD pump

Interventions

Acetaminophen 650 mg Oral Tablet DRUG

650 mg pills

Also known as: Tylenol

Nurse Administered Acetaminophen

Acetaminophen 650mg Liquid DRUG

650 mg liquid

Also known as: Tylenol

CADD pump Administered Acetaminophen (Participant Controlled)

CADD pump DEVICE

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

CADD pump Administered Acetaminophen (Participant Controlled)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital at St. Raphael's Campus

New Haven, Connecticut, 06520, United States

RECRUITING

MeSH Terms

Conditions

Pain; Pain, Postoperative; Agnosia

Interventions

Acetaminophen; Tablets; Fluid Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Dosage Forms; Pharmaceutical Preparations; Drug Therapy; Therapeutics

Study Officials

• Jinlei Li, MD, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinlei Li, MD, PhD

CONTACT

475-434-4038; jinlei.li@yale.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients undergoing total shoulder arthroplasty or reverse total shoulder arthroplasty at Yale New Haven Hospital at St. Raphael's Campus.

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 12, 2024
• Study Start: November 19, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)