Patient Controlled Analgesia Pump Cues on Patient Satisfaction

Study Overview
=================
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.

Official Title
-----------------
The Effect of Patient Controlled Analgesia Pump Cues on Patient Satisfaction

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Device: Patient-Controlled Analgesia pump with Cues
* Device: Patient-Controlled Analgesia pump without Cues
* Drug: Morphine


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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 |