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

The Effect of 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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Device: Patient-Controlled Analgesia pump with Cues; Drug: Morphine; Device: Patient-Controlled Analgesia pump without Cues

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.

• Study Type: Interventional
• Enrollment (Actual): 176
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53201
      • Children's Hospital of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cues; The PCA pump will be programmed to provide a cue to the end of the lockout period.	Device: Patient-Controlled Analgesia pump with Cues; The end of the lockout period will be cued via the PCA pump; Drug: Morphine; Morphine will be administered for post-operative pain in both the Cues and Non-Cues groups
Placebo Comparator: No Cues; The PCA pump will be programmed such that no cues will be provided to the end of the lockout period (current standard of care).	Drug: Morphine; Morphine will be administered for post-operative pain in both the Cues and Non-Cues groups; Device: Patient-Controlled Analgesia pump without Cues; The PCA pump will be programmed such that no cues will be provided to the end of the lockout period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction Questionnaire	Patient satisfaction with their PCA pump. Satisfaction was measured on a 0 to 10 scale, with higher numbers indicating greater satisfaction.	Up to 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Consumption (Total Amount of Opioid Consumed Post-operatively)	Total amount of opioid consumed post-operatively in mg/kg/hour.	Post-op Days [POD] 0 - 2, up to 72 hours
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.	Up to 72 hours

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Collaborators: Children's Hospital and Health System Foundation, Wisconsin
• Investigators: Principal Investigator: Keri R. Hainsworth, PhD, Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): October 3, 2019
• Study Completion (Actual): October 3, 2019

Study Registration Dates

• First Submitted: April 27, 2015
• First Submitted That Met QC Criteria: May 28, 2015
• First Posted (Estimate): May 29, 2015

Study Record Updates

• Last Update Posted (Actual): September 8, 2021
• Last Update Submitted That Met QC Criteria: August 11, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: NICU_RCT