Evaluation of Oral PCA Device - PCoA™ Acute

NCT03134001 | Completed

• 1 other identifier: PCoAAcute001
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Number of pill intakes during the study

  48hr

Study Arms (2)

Test Group

EXPERIMENTAL

Patients receiving oral analgesics via the PCoA™ Acute device

Device: patients receiving oral analgesics via the PCoA™ Acute

Control Group

NO INTERVENTION

Patients receiving oral analgesics by nurse, upon request

Interventions

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.

Test Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Dosentrx Ltd.: lead

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: April 25, 2017
• First Posted: April 28, 2017
• Study Start: June 1, 2015
• Primary Completion: November 30, 2015
• Study Completion: November 30, 2015
• Last Updated: May 8, 2017

Record last verified: 2017-04