PCDD Generation 1 Oral Liquid Acetaminophen Delivery Evaluation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- PCDD Generation 1 system
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov