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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Acetaminophen delivery using the PCDD systemExperimental treatment 1 intervention
Group B: Standard nurse-administered acetaminophenNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Participant enrollment rate
Percent participants enrolled out of all screened
Time frame
1-7 days prior to surgery2
Retention in assigned treatment group
Percentage of participants who remain in their assigned treatment group for the duration of study participation.
Time frame
From enrollment to discharge, up to 3 days3
Mean score Patient Questionnaire
Patient satisfaction with PCDD system. Total score range 0-10 with higher scores indicating more satisfaction.
Time frame
Baseline up to Day 34
Mean score Nurse Questionnaire
Nurse satisfaction with PCDD system. Total score range 0-10 with higher scores indicating more satisfaction.
Time frame
Baseline up to Day 3Secondary outcomes
1
Mean Acetaminophen consumption
Postoperative acetaminophen consumption in milligrams will be monitored between anesthesia end time and discharge time.
Time frame
From anesthesia end time to discharge time, up to 48 hours2
Mean Opioid consumption
Postoperative opioid consumption in oral milligram morphine equivalent (OME) will be monitored between anesthesia end time and discharge time.
Time frame
From anesthesia end time to discharge time, up to 48 hours3
Mean Pain scores
Participants will be asked via Pain Diary to rate their pain using numeric pain scores from 0 to 10, 0 as no pain, 10 is the worst possible.
Time frame
From anesthesia end time to discharge time, up to 48 hours4
Mean Time to first opioid request
Mean time in minutes from the time when opioid medication requested by the participant to the time opioid medication is delivered
Time frame
From anesthesia end time to discharge time, up to 48 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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