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Completed

NCT Number: NCT03134001

Evaluation of Oral PCA Device - PCoA™ Acute

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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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Treatment and study plan

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.

Primary outcomes

  1. PCoA™ Acute safety

    Time frame: 48 hr

    No pill overdose, No pills malformation upon dispensing, No pill inhalation during pill sucking, 4. No adverse events

  2. PCoA™ Acute efficacy

    Time frame: 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

  3. PCoA™ Acute usability

    Time frame: 48hr

    At least 80% of patients and medical staff are satisfied with device use and will recommend its use for their colleagues

Secondary outcomes

  1. Number of pill intakes during the study

    Time frame: 48hr

    Number of pain medications obtained by the patients during the study

Sponsors and collaborators

Lead sponsor

Dosentrx Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 28, 2017
Registry last updated
May 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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