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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group | Experimental | Patients receiving oral analgesics via the PCoA™ Acute device |
|
| Control Group | No Intervention | Patients receiving oral analgesics by nurse, upon request |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| patients receiving oral analgesics via the PCoA™ Acute | Device | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of pill intakes during the study | Number of pain medications obtained by the patients during the study | 48hr |
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Inclusion Criteria:
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.
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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Study includes 2 groups: test group comprised patients receiving oral analgesics via the PCoA™ Acute and control group of nurse providing analgesics.
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|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |