PCDD Generation 1 Oral Liquid Acetaminophen Delivery Evaluation (NCT07765238)
Evaluation of the Patient-Controlled Dispenser & Deactivator (PCDD) Generation 1 System for Oral Liquid Acetaminophen Delivery
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (8 items).
Location: Yale New Haven Hospital SRC — New Haven, Connecticut
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria: Participants
- Patient refusal to participate
- Pregnancy: all child bearing age patients will receive a urine screening test on the day of surgery and this result will be documented in the EMR epic. This is an elective procedure and the surgery will almost always be cancelled in the case of positive pregnancy test. In the extremely rare event the care proceeds, we will exclude the patient from the study. Emergency surgery
- Cognitive impairment preventing informed consent or independent use of the device
- Chronic pain requiring ongoing pain management or home opioid use
- Substance use disorder
- Failed preoperative brachial plexus block, defined as significant postoperative pain in the PACU requiring early escalation of analgesic management Nurses
- Declines or is unwilling to provide informed consent.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Yale New Haven Hospital SRC — New Haven, Connecticut
📞 Contact the Study Coordinator
Phone: (475) 434-4038
Email: jinlei.li@yale.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
- 💵 Compensation indicated: Exclusion Criteria: Participants * Patient refusal to participate * Pregnancy: all child bearing age patients will receive a urine screening test on the day of surgery and this result will be doc...
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.