Patient Controlled Analgesia Pump Cues on Patient Satisfaction

Postoperative Pain Clinical Trial

— PCA Cues  

Official title:

The Effect of Patient Controlled Analgesia Pump Cues on Patient Satisfaction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02456909
• Other study ID #: NICU_RCT
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: October 3, 2019

Study information

• Verified date: August 2021
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: October 3, 2019
• Est. primary completion date: October 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Device:
• Patient-Controlled Analgesia pump with Cues
The end of the lockout period will be cued via the PCA pump
• 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.

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

Locations

Country	Name	City	State
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Children's Hospital and Health System Foundation, Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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