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OpenTrials
Completed

NCT Number: NCT02456909

Patient Controlled Analgesia Pump Cues on Patient Satisfaction

To examine whether providing patients with a cue to the availability of pain medication affects patient satisfaction, patient anxiety, PCA efficacy, and safety.

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Key information

Conditions

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

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53201, United States

About this study

Post-operative pain is primarily managed via Patient-Controlled Analgesia (PCA). The newest PCA pumps can be programmed so that the button is backlit with a green light at the end of the lockout period, and the green light flashes when the medication is being dispensed. No studies have examined whether this type of visual cue would influence satisfaction or other patient outcomes (such as opioid consumption, PCA safety and patient anxiety) in children and adolescents, and no studies have examined whether pediatric patients' perspectives would be similar to those of adults.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 7-18 years
  • Opioid naïve
  • Scheduled for a surgery for which a PCA is routinely used for post-operative pain management
  • At least 1 parent speaks English

Exclusion criteria

  • Prior experience with PCA
  • Cognitive delay precluding independent use of the PCA button
  • Current use of anxiolytics or antidepressants
  • Patients receiving epidural analgesia

Treatment and study plan

Patient-Controlled Analgesia pump with Cues

Device

The end of the lockout period will be cued via the PCA pump

Patient-Controlled Analgesia pump without Cues

Device

The PCA pump will be programmed such that no cues will be provided to the end of the lockout period.

Morphine

Drug

Morphine will be administered for post-operative pain in both the Cues and Non-Cues groups

Primary outcomes

  1. Patient Satisfaction Questionnaire

    Time frame: Up to 72 hours

    Patient satisfaction with their PCA pump. Satisfaction was measured on a 0 to 10 scale, with higher numbers indicating greater satisfaction.

Secondary outcomes

  1. Opioid Consumption (Total Amount of Opioid Consumed Post-operatively)

    Time frame: Post-op Days [POD] 0 - 2, up to 72 hours

    Total amount of opioid consumed post-operatively in mg/kg/hour.

  2. Anxiety (State Anxiety on POD 1 and POD 2)

    Time frame: Up to 72 hours

    State anxiety on POD 1 and POD 2. The total score is presented as a T-score, which ranges from 0 to 100, with higher scores indicating greater levels of state anxiety. With a T-score, the mean is always 50, and the standard deviation is always 10.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • Children's Hospital and Health System Foundation, Wisconsin

Registry information

Official study title

The Effect of Patient Controlled Analgesia Pump Cues on Patient Satisfaction

Acronym: PCA Cues

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
May 29, 2015
Registry last updated
Sep 8, 2021

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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