NCT06498713 Patient Controlled Administration of Liquid Acetaminophen
| NCT ID | NCT06498713 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Yale University |
| Condition | Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2024-11-19 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2024-11-19 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Jinlei Li, MD, PhD
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT06498713 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06498713 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06498713 currently recruiting?
Yes, NCT06498713 is actively recruiting participants. Contact the research team at jinlei.li@yale.edu for enrollment information.
Where is the NCT06498713 trial being conducted?
This trial is being conducted at New Haven, United States.
Who is sponsoring the NCT06498713 clinical trial?
NCT06498713 is sponsored by Yale University. The principal investigator is Jinlei Li, MD, PhD at Yale University. The trial plans to enroll 24 participants.