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Patient Controlled Analgesia Pump Cues on Patient Satisfaction (PCA Cues)

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient-Controlled Analgesia pump with Cues
Patient-Controlled Analgesia pump without Cues
Morphine
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cues

No Cues

Arm Description

The PCA pump will be programmed to provide a cue to the end of the lockout period.

The PCA pump will be programmed such that no cues will be provided to the end of the lockout period (current standard of care).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Opioid Consumption (Total Amount of Opioid Consumed Post-operatively)
Total amount of opioid consumed post-operatively in mg/kg/hour.
Anxiety (State Anxiety on POD 1 and POD 2)
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.

Full Information

First Posted
April 27, 2015
Last Updated
August 11, 2021
Sponsor
Medical College of Wisconsin
Collaborators
Children's Hospital and Health System Foundation, Wisconsin
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1. Study Identification

Unique Protocol Identification Number
NCT02456909
Brief Title
Patient Controlled Analgesia Pump Cues on Patient Satisfaction
Acronym
PCA Cues
Official Title
The Effect of Patient Controlled Analgesia Pump Cues on Patient Satisfaction
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
October 3, 2019 (Actual)
Study Completion Date
October 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
Collaborators
Children's Hospital and Health System Foundation, Wisconsin

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
176 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cues
Arm Type
Experimental
Arm Description
The PCA pump will be programmed to provide a cue to the end of the lockout period.
Arm Title
No Cues
Arm Type
Placebo Comparator
Arm Description
The PCA pump will be programmed such that no cues will be provided to the end of the lockout period (current standard of care).
Intervention Type
Device
Intervention Name(s)
Patient-Controlled Analgesia pump with Cues
Intervention Description
The end of the lockout period will be cued via the PCA pump
Intervention Type
Device
Intervention Name(s)
Patient-Controlled Analgesia pump without Cues
Intervention Description
The PCA pump will be programmed such that no cues will be provided to the end of the lockout period.
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
Morphine will be administered for post-operative pain in both the Cues and Non-Cues groups
Primary Outcome Measure Information:
Title
Patient Satisfaction Questionnaire
Description
Patient satisfaction with their PCA pump. Satisfaction was measured on a 0 to 10 scale, with higher numbers indicating greater satisfaction.
Time Frame
Up to 72 hours
Secondary Outcome Measure Information:
Title
Opioid Consumption (Total Amount of Opioid Consumed Post-operatively)
Description
Total amount of opioid consumed post-operatively in mg/kg/hour.
Time Frame
Post-op Days [POD] 0 - 2, up to 72 hours
Title
Anxiety (State Anxiety on POD 1 and POD 2)
Description
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.
Time Frame
Up to 72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keri R. Hainsworth, PhD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53201
Country
United States

12. IPD Sharing Statement

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Patient Controlled Analgesia Pump Cues on Patient Satisfaction

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