Back to resultsEvaluation of Oral PCA Device - PCoA™ Acute
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
patients receiving oral analgesics via the PCoA™ Acute
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
Eligibility Criteria
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.
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Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Test Group
Control Group
Arm Description
Patients receiving oral analgesics via the PCoA™ Acute device
Patients receiving oral analgesics by nurse, upon request
Outcomes
Primary Outcome Measures
PCoA™ Acute safety
No pill overdose, No pills malformation upon dispensing, No pill inhalation during pill sucking, 4. No adverse events
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
PCoA™ Acute usability
At least 80% of patients and medical staff are satisfied with device use and will recommend its use for their colleagues
Secondary Outcome Measures
Number of pill intakes during the study
Number of pain medications obtained by the patients during the study
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03134001
Brief Title
Evaluation of Oral PCA Device - PCoA™ Acute
Official Title
Evaluation of Oral Patient-Controlled Analgesia (PCA) Device - PCoA™ Acute , for Hospitalized Patients With Post-operative Pain
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 1, 2015 (Actual)
Primary Completion Date
November 30, 2015 (Actual)
Study Completion Date
November 30, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dosentrx Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test Group
Arm Type
Experimental
Arm Description
Patients receiving oral analgesics via the PCoA™ Acute device
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patients receiving oral analgesics by nurse, upon request
Intervention Type
Device
Intervention Name(s)
patients receiving oral analgesics via the PCoA™ Acute
Intervention Description
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.
Primary Outcome Measure Information:
Title
PCoA™ Acute safety
Description
No pill overdose, No pills malformation upon dispensing, No pill inhalation during pill sucking, 4. No adverse events
Time Frame
48 hr
Title
PCoA™ Acute efficacy
Description
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
Time Frame
48hr
Title
PCoA™ Acute usability
Description
At least 80% of patients and medical staff are satisfied with device use and will recommend its use for their colleagues
Time Frame
48hr
Secondary Outcome Measure Information:
Title
Number of pill intakes during the study
Description
Number of pain medications obtained by the patients during the study
Time Frame
48hr
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Evaluation of Oral PCA Device - PCoA™ Acute
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