Status:
RECRUITING
Patient Controlled Administration of Liquid Acetaminophen
Lead Sponsor:
Yale University
Conditions:
Pain
Pain, Postoperative
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 hosp...
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 stud...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06498713
Start Date
November 19 2024
End Date
December 1 2025
Last Update
October 29 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Yale New Haven Hospital at St. Raphael's Campus
New Haven, Connecticut, United States, 06520