Patient Controlled Analgesia Pump Cues on Patient Satisfaction

NCT02456909 | Completed Results

• 1 other identifier: NICU_RCT
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Opioid Consumption (Total Amount of Opioid Consumed Post-operatively)

  Post-op Days [POD] 0 - 2, up to 72 hours

• Anxiety (State Anxiety on POD 1 and POD 2)

  Up to 72 hours

Study Arms (2)

Cues

EXPERIMENTAL

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

Device: Patient-Controlled Analgesia pump with Cues; Drug: Morphine

No Cues

PLACEBO COMPARATOR

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; Drug: Morphine

Interventions

Patient-Controlled Analgesia pump with Cues DEVICE

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

Cues

Patient-Controlled Analgesia pump without Cues DEVICE

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

No Cues

Morphine DRUG

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

Cues; No Cues

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Prior experience with PCA
• Cognitive delay precluding independent use of the PCA button
• Current use of anxiolytics or antidepressants
• Patients receiving epidural analgesia

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Children's Hospital and Health System Foundation, Wisconsin: collaborator

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53201, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Morphine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Keri R. Hainsworth, PhD
• Organization: Medical College of Wisconsin

khainswo@mcw.edu

414-266-6306

Study Officials

• Keri R. Hainsworth, PhD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 27, 2015
• First Posted: May 29, 2015
• Study Start: April 1, 2015
• Primary Completion: October 3, 2019
• Study Completion: October 3, 2019
• Last Updated: September 8, 2021
• Results First Posted: September 8, 2021

Record last verified: 2021-08

Locations

US (1)