Patient Controlled Analgesia Pump Cues on Patient Satisfaction

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2019-10-03

Brief Summary

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

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Detailed Description

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Cues

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

Group Type EXPERIMENTAL

Patient-Controlled Analgesia pump with Cues

Intervention Type DEVICE

The end of the lockout period will be cued via the PCA pump

Morphine

Intervention Type DRUG

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

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).

Group Type PLACEBO_COMPARATOR

Patient-Controlled Analgesia pump without Cues

Intervention Type DEVICE

The PCA pump will be programmed such that no cues will be provided to the end of the lockout period.

Morphine

Intervention Type DRUG

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

Interventions

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Patient-Controlled Analgesia pump with Cues

The end of the lockout period will be cued via the PCA pump

Intervention Type 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.

Intervention Type DEVICE

Morphine

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

7 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No