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Clinical Trial NCT06498713 for Pain, Pain, Postoperative is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Patient Controlled Administration of Liquid Acetaminophen Phase 1 24

Recruiting
Clinical Trial NCT06498713 is designed to study Treatment for Pain, Pain, Postoperative. It is a Phase 1 interventional study that is recruiting, having started on 19 November 2024, with plans to enroll 24 participants. Led by Yale University, it is expected to complete by 1 December 2025. The latest data from ClinicalTrials.gov was last updated on 29 October 2025.
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.
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 les...Show More
Official Title

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

Conditions
PainPain, Postoperative
Other Study IDs
  • 2000037919
NCT ID Number
NCT06498713
Start Date (Actual)
2024-11-19
Last Update Posted
2025-10-29
Completion Date (Estimated)
2025-12
Enrollment (Estimated)
24
Study Type
Interventional
PHASE
Phase 1
Status
Recruiting
Keywords
Pain Management
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorNurse Administered Acetaminophen
Participants will receive acetaminophen pills 650 mg every 4 hours as needed (PRN) administered by nurse per standard of care
Acetaminophen 650 mg Oral Tablet
650 mg pills
ExperimentalCADD 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).
Acetaminophen 650mg Liquid
650 mg liquid
CADD pump
Primed and programmed to delivery 650 mg liquid acetaminophen into a medication cup every 4 hours as needed.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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 MeasureMeasure DescriptionTime 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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All

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.

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.
Yale University logoYale University457 active studies to explore
Study Central Contact
Contact: Jinlei Li, MD, PhD, 475-434-4038, [email protected]
1 Study Locations in 1 Countries

Connecticut

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