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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02456909
Recruitment Status : Completed
First Posted : May 29, 2015
Last Update Posted : October 4, 2019
Sponsor:
Collaborator:
Children's Hospital and Health System Foundation, Wisconsin
Information provided by (Responsible Party):
Keri Hainsworth, 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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Device: Patient-Controlled Analgesia pump with Cues Device: Patient-Controlled Analgesia pump without Cues Drug: Morphine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effect of Patient Controlled Analgesia Pump Cues on Patient Satisfaction
Study Start Date : April 2015
Actual Primary Completion Date : October 3, 2019
Actual Study Completion Date : October 3, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cues
The PCA pump will be programmed to provide a cue to the end of the lockout period.
Device: Patient-Controlled Analgesia pump with Cues
The end of the lockout period will be cued via the PCA pump

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

Placebo Comparator: 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).
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.

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




Primary Outcome Measures :
  1. Patient Satisfaction Questionnaire [ Time Frame: Up to 72 hours ]
    Patient satisfaction with their PCA pump


Secondary Outcome Measures :
  1. Opioid consumption (Total amount of opioid consumed post-operatively) [ Time Frame: Up to 72 hours ]
  2. Anxiety (State anxiety on POD 1 and POD 2) [ Time Frame: Up to 72 hours ]
    State anxiety on POD 1 and POD 2



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02456909


Locations
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United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53201
Sponsors and Collaborators
Medical College of Wisconsin
Children's Hospital and Health System Foundation, Wisconsin
Investigators
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Principal Investigator: Keri R. Hainsworth, PhD Medical College of Wisconsin
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Responsible Party: Keri Hainsworth, Associate Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT02456909    
Other Study ID Numbers: NICU_RCT
First Posted: May 29, 2015    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents