Evaluation of Oral PCA Device - PCoA™ Acute

Not Applicable

Completed

• Conditions: Pain, Postoperative
• Interventions: Device: patients receiving oral analgesics via the PCoA™ Acute

• Registration Number: NCT03134001
• Lead Sponsor: Dosentrx Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-01
• Primary Completion: 2015-11-30
• Study Completion: 2015-11-30
• Status Verified: 2017-04
• Study First Submitted: 2017-04-25
• Study First Submitted QC: 2017-04-27
• Study First Posted: 2017-04-28
• Last Update Submitted: 2017-05-03
• Last Update Posted: 2017-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Test Group	patients receiving oral analgesics via the PCoA™ Acute	Patients receiving oral analgesics via the PCoA™ Acute device

Primary Outcome Measures

Name	Time	Method
PCoA™ Acute safety	48 hr	No pill overdose, No pills malformation upon dispensing, No pill inhalation during pill sucking, 4. No adverse events
PCoA™ Acute efficacy	48hr	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	48hr	At least 80% of patients and medical staff are satisfied with device use and will recommend its use for their colleagues

Secondary Outcome Measures

Name	Time	Method
Number of pill intakes during the study	48hr	Number of pain medications obtained by the patients during the study