Evaluation of Oral PCA Device - PCoA™ Acute

Evaluation of Oral Patient-Controlled Analgesia (PCA) Device - PCoA™ Acute , for Hospitalized Patients With Post-operative Pain

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03134001

Enrollment

Registered

2017-04-28

Start date

2015-06-01

Completion date

2015-11-30

Last updated

2017-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Brief summary

Randomized, open label, controlled pilot clinical study comprised hospitalized post operative patients receiving oral analgesics. The study aims to evaluate the safety, efficacy and usability of a novel pill dispensing system - PCoA™ Acute and compare it to the conventional procedure of nurse providing analgesics.

Interventions

DEVICEpatients receiving oral analgesics via the PCoA™ Acute

PCoA™ Acute is an oral PCA device, designed to provide safe and easy-to-use pain medication at the bedside. It identifies patients by Radio Frequency Identification (RFID) technology and provides pill dispensing upon patient's request.

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Study includes 2 groups: test group comprised patients receiving oral analgesics via the PCoA™ Acute and control group of nurse providing analgesics.

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. Operative procedure with at least 3 days' hospital stay. 2. Planned post-operative pain therapy with oral medication using a strong opioid. 3. No contra-indication for opioid therapy. 4. No contra-indication for oral pain therapy. 5. Patient was able to understand and complete the questionnaire. 6. Patient signed an informed consent form.

Exclusion criteria

1\. Opioid or drug addiction. 2. Opioid intolerance. 3. Pain therapy using IV PCA or infusion. 4. Rejection of opioid therapy. 5. Not able to swallow medicine. \-

Design outcomes

Primary

Measure	Time frame	Description
PCoA™ Acute safety	48 hr	No pill overdose, No pills malformation upon dispensing, No pill inhalation during pill sucking, 4. No adverse events
PCoA™ Acute efficacy	48hr	Success rate of 90% for pill intake upon patient's request, No critical device malfunction, Time of pill intake reduced by at least 50% in the test group compared to the control group
PCoA™ Acute usability	48hr	At least 80% of patients and medical staff are satisfied with device use and will recommend its use for their colleagues

Secondary

Measure	Time frame	Description
Number of pill intakes during the study	48hr	Number of pain medications obtained by the patients during the study

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026