Patient Controlled Analgesia Pump Cues on Patient Satisfaction

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Device: Patient-Controlled Analgesia pump with Cues; Device: Patient-Controlled Analgesia pump without Cues; Drug: Morphine

• Registration Number: NCT02456909
• Lead Sponsor: Medical College of Wisconsin

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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-27
• Study First Submitted QC: 2015-05-28
• Study First Posted: 2015-05-29
• Primary Completion: 2019-10-03
• Study Completion: 2019-10-03
• Results First Submitted: 2021-06-11
• Status Verified: 2021-08
• Results First Submitted QC: 2021-08-11
• Last Update Submitted: 2021-08-11
• Results First Posted: 2021-09-08
• Last Update Posted: 2021-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cues	Patient-Controlled Analgesia pump with Cues	The PCA pump will be programmed to provide a cue to the end of the lockout period.
Cues	Morphine	The PCA pump will be programmed to provide a cue to the end of the lockout period.
No Cues	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 (current standard of care).
No Cues	Morphine	The PCA pump will be programmed such that no cues will be provided to the end of the lockout period (current standard of care).

Primary Outcome Measures

Name	Time	Method
Patient Satisfaction Questionnaire	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 Outcome Measures

Name	Time	Method
Opioid Consumption (Total Amount of Opioid Consumed Post-operatively)	Post-op Days [POD] 0 - 2, up to 72 hours	Total amount of opioid consumed post-operatively in mg/kg/hour.
Anxiety (State Anxiety on POD 1 and POD 2)	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.

Trial Locations

Locations (1)

Children's Hospital of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States