Evaluation of Oral PCA Device - PCoA™ Acute

Dosentrx

Status: Completed

Conditions: Pain, Postoperative

Treatments: Device: patients receiving oral analgesics via the PCoA™ Acute

Study type: Interventional

Funder types: Industry

Identifiers

NCT03134001

PCoAAcute001

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Test Group

Experimental group

Description:

Patients receiving oral analgesics via the PCoA™ Acute device

Treatment:

Device: patients receiving oral analgesics via the PCoA™ Acute

Control Group

No Intervention group

Description:

Patients receiving oral analgesics by nurse, upon request