Patient Controlled Administration of Liquid Acetaminophen

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Pain, Postoperative
• Intervention / Treatment: Drug: Acetaminophen 650 mg Oral Tablet; Drug: Acetaminophen 650mg Liquid; Device: CADD pump

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jinlei Li, MD, PhD; Phone Number: 475-434-4038; Email: jinlei.li@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Recruiting
      • Yale New Haven Hospital at St. Raphael's Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nurse Administered Acetaminophen; 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; 650 mg pills; Other Names: Tylenol
Experimental: CADD pump Administered Acetaminophen (Participant Controlled); 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; 650 mg liquid; Other Names: Tylenol; Device: CADD pump; Primed and programmed to delivery 650 mg liquid acetaminophen into a medication cup every 4 hours as needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean daily acetaminophen consumption	Mean daily acetaminophen consumption in milligrams collected using the electronic medical record	12 months
Mean Pain score	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.	12 months
Mean time to medication delivery	Medication delivery: Mean time in minutes from the time when pain medication requested by the participant to the time pain medication is delivered	12 months

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Jinlei Li, MD, PhD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: July 5, 2024
• First Submitted That Met QC Criteria: July 5, 2024
• First Posted (Actual): July 12, 2024

Study Record Updates

• Last Update Posted (Estimated): October 29, 2025
• Last Update Submitted That Met QC Criteria: October 27, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Pain Management
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Pain, Postoperative; Agnosia; Organic Chemicals; Pharmaceutical Preparations; Therapeutics; Dosage Forms; Drug Therapy; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Acetaminophen; Tablets; Fluid Therapy
• Other Study ID Numbers: 2000037919

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No