Evaluation of Oral PCA Device - PCoA™ Acute

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03134001
• Other study ID #: PCoAAcute001
• Status: Completed
• Phase: N/A
• First received: April 25, 2017
• Last updated: May 3, 2017
• Start date: June 1, 2015
• Est. completion date: November 30, 2015

Study information

• Verified date: April 2017
• Source: Dosentrx Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 30, 2015
• Est. primary completion date: November 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dosentrx Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PCoA™ Acute safety	No pill overdose, No pills malformation upon dispensing, No pill inhalation during pill sucking, 4. No adverse events	48 hr
Primary	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
Primary	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	Number of pill intakes during the study	Number of pain medications obtained by the patients during the study	48hr