Evaluation of the Patient-Controlled Dispenser & Deactivator (PCDD) Generation 1 System for Oral Liquid Acetaminophen Delivery
Yale University
Summary
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.
Description
The primary objective of this prospective pilot study is to determine the feasibility of patient-controlled administration of liquid oral acetaminophen using the Patient-Controlled Dispenser and Deactivator (PCDD) system, using recruitment rate and cross-over rates as surrogate markers. The secondary objective of this study is to determine the preliminary efficacy of patient-controlled delivery of oral acetaminophen administration using the PCDD system.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Participants * Admitted to the participating orthopedic service for elective total shoulder replacement * Received a preoperative brachial plexus block * English speaking - as on-site study members are only fluent in English * Able to independently use the PCDD system and follow basic operating instructions Nurses * Registered nurse employed at Yale New Haven Hospital. * Provides clinical care to an enrolled study participant during the participant's hospitalization. * Willing and able to provide informed consent. Exclusion Criteria: Participants * Patient refusal to…
Interventions
- DevicePCDD Generation 1 system
Dispenses 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.
Location
- Yale New Haven Hospital SRCNew Haven, Connecticut