Evaluation of Oral PCA Device - PCoA™ Acute

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Device: patients receiving oral analgesics via the PCoA™ Acute


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Operative procedure with at least 3 days' hospital stay. Planned post-operative pain therapy with oral medication using a strong opioid. No contra-indication for opioid therapy. No contra-indication for oral pain therapy. Patient was able to understand and complete the questionnaire. 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. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Study includes 2 groups: test group comprised patients receiving oral analgesics via the PCoA™ Acute and control group of nurse providing analgesics.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Group<br>Patients receiving oral analgesics via the PCoA™ Acute device | Device: patients receiving oral analgesics via the PCoA™ Acute<br>* 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.<br>|
| No Intervention: Control Group<br>Patients receiving oral analgesics by nurse, upon request | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCoA™ Acute safety | No pill overdose, No pills malformation upon dispensing, No pill inhalation during pill sucking, 4. No adverse events | 48 hr | 
| PCoA™ Acute efficacy | 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 | 48hr | 
| PCoA™ Acute usability | At least 80% of patients and medical staff are satisfied with device use and will recommend its use for their colleagues | 48hr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of pill intakes during the study | Number of pain medications obtained by the patients during the study | 48hr |