PCDD Generation 1 Oral Liquid Acetaminophen Delivery Evaluation
Part of paid clinical trials in New Haven, Connecticut.
- Sponsor
- Yale University
- Study ID
- NCT07765238
- Status
- Not Yet Recruiting
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Conditions
- Pain Management
- Postoperative Pain
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- PCDD Generation 1 system — DEVICEDispenses prescribed oral liquid medication through a secure, patient-activated mechanism . The system provides access to as needed oral liquid doses only within the prescribed dosing eligibility window.
Study Details
This prospective randomized pilot study evaluates the feasibility, acceptability, and preliminary efficacy of the Patient-Controlled Dispenser and Deactivator (PCDD) Generation 1 system for patient-controlled oral liquid acetaminophen administration in postoperative total shoulder replacement inpatients compared with standard nurse-administered oral acetaminophen delivery.
Key Dates
- First listed
- Aug 14, 2026
- Start date
- Aug 31, 2026
- Status verified
- Aug 2026
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Acetaminophen delivery using the PCDD systemPatient-controlled oral liquid acetaminophen delivery using the PCDD system in postoperative total shoulder replacement while inpatient.
- No Intervention: Standard nurse-administered acetaminophenParticipants will receive standard nurse-administered as-needed acetaminophen pills in postoperative total shoulder replacement while inpatient.
Primary Outcome Measure
Participant enrollment rate [ Time Frame: 1-7 days prior to surgery ]
Central Contacts
- Jinlei Li, MD PhD475-434-4038
- Daniel Wiznia, MD(203) 785-2579
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Yale New Haven Hospital SRC | New Haven | Connecticut | 06520 | - |
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