Evaluation of Oral PCA Device - PCoA™ Acute

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Device: patients receiving oral analgesics via the PCoA™ Acute

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dosentrx Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): November 30, 2015
• Study Completion (Actual): November 30, 2015

Study Registration Dates

• First Submitted: April 25, 2017
• First Submitted That Met QC Criteria: April 27, 2017
• First Posted (Actual): April 28, 2017

Study Record Updates

• Last Update Posted (Actual): May 8, 2017
• Last Update Submitted That Met QC Criteria: May 3, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Analgesics
• Other Study ID Numbers: PCoAAcute001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No