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

• ClinicalTrials.gov Identifier: NCT02456909
• Recruitment Status: Completed
• First Posted: May 29, 2015
• Last Update Posted: October 4, 2019
• Sponsor: Medical College of Wisconsin
• Collaborator: Children's Hospital and Health System Foundation, Wisconsin
• Information provided by (Responsible Party): Keri Hainsworth, Medical College of Wisconsin

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Principal Investigator: Keri R. Hainsworth, PhD; Medical College of Wisconsin

More Information

• 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
• Last Update Posted: October 4, 2019
• Last Verified: October 2019

Additional relevant MeSH terms:

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