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

Medical College of Wisconsin

Status: Completed

Conditions: Postoperative Pain

Treatments: Device: Patient-Controlled Analgesia pump with Cues; Device: Patient-Controlled Analgesia pump without Cues; Drug: Morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT02456909

NICU_RCT

Details and patient eligibility

About

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

Full 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.

Enrollment: 176 patients

Sex: All

Ages: 7 to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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176 participants in 2 patient groups, including a placebo group

Cues

Experimental group

Description:

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

Treatment:

Device: Patient-Controlled Analgesia pump with Cues

Drug: Morphine

No Cues

Placebo Comparator group

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).

Treatment:

Device: Patient-Controlled Analgesia pump without Cues

Drug: Morphine