Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Children's Hospital and Health System Foundation, Wisconsin | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To examine whether providing patients with a cue to the availability of pain medication affects patient satisfaction, patient anxiety, PCA efficacy, and safety.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cues | Experimental | The PCA pump will be programmed to provide a cue to the end of the lockout period. |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient-Controlled Analgesia pump with Cues | Device | The end of the lockout period will be cued via the PCA pump |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Consumption (Total Amount of Opioid Consumed Post-operatively) | Total amount of opioid consumed post-operatively in mg/kg/hour. | Post-op Days [POD] 0 - 2, up to 72 hours |
| Anxiety (State Anxiety on POD 1 and POD 2) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Keri R. Hainsworth, PhD | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53201 | United States |
Not provided
Participants could not be recruited after surgery; therefore, all eligible participants were recruited, but not all received a PCA after surgery.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cues | The PCA pump will be programmed to provide a cue to the end of the lockout period. Patient-Controlled Analgesia pump with Cues: The end of the lockout period will be cued via the PCA pump Morphine: Morphine will be administered for post-operative pain in both the Cues and Non-Cues groups |
| FG001 | 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). 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. Morphine: Morphine will be administered for post-operative pain in both the Cues and Non-Cues groups |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cues | The PCA pump will be programmed to provide a cue to the end of the lockout period. Patient-Controlled Analgesia pump with Cues: The end of the lockout period will be cued via the PCA pump Morphine: Morphine will be administered for post-operative pain in both the Cues and Non-Cues groups |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Satisfaction Questionnaire | Patient satisfaction with their PCA pump. Satisfaction was measured on a 0 to 10 scale, with higher numbers indicating greater satisfaction. | Includes participants who completed the post-intervention survey. | Posted | Median | Inter-Quartile Range | units on a scale | Up to 72 hours |
|
72 hours
Deaths were not assessed in this protocol.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cues | The PCA pump will be programmed to provide a cue to the end of the lockout period. Patient-Controlled Analgesia pump with Cues: The end of the lockout period will be cued via the PCA pump Morphine: Morphine will be administered for post-operative pain in both the Cues and Non-Cues groups |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Itching requiring treatment on POD 0 | Skin and subcutaneous tissue disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Keri R. Hainsworth, PhD | Medical College of Wisconsin | 414-266-6306 | khainswo@mcw.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 30, 2015 | Feb 22, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D009020 | Morphine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
| Morphine | Drug | Morphine will be administered for post-operative pain in both the Cues and Non-Cues groups |
|
State anxiety on POD 1 and POD 2. The total score is presented as a T-score, which ranges from 0 to 100, with higher scores indicating greater levels of state anxiety. With a T-score, the mean is always 50, and the standard deviation is always 10.
| Up to 72 hours |
| 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). 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. Morphine: Morphine will be administered for post-operative pain in both the Cues and Non-Cues groups |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Categorical | Count of Participants | Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
The PCA pump will be programmed such that no cues will be provided to the end of the lockout period (current standard of care).
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.
Morphine: Morphine will be administered for post-operative pain in both the Cues and Non-Cues groups
|
|
| Secondary | Opioid Consumption (Total Amount of Opioid Consumed Post-operatively) | Total amount of opioid consumed post-operatively in mg/kg/hour. | Posted | Median | Inter-Quartile Range | mg/kg/hr | Post-op Days [POD] 0 - 2, up to 72 hours |
|
|
|
| Secondary | Anxiety (State Anxiety on POD 1 and POD 2) | State anxiety on POD 1 and POD 2. The total score is presented as a T-score, which ranges from 0 to 100, with higher scores indicating greater levels of state anxiety. With a T-score, the mean is always 50, and the standard deviation is always 10. | Posted | Median | Inter-Quartile Range | units on a scale | Up to 72 hours |
|
|
|
| 0 |
| 0 |
| 0 |
| 64 |
| 11 |
| 64 |
| EG001 | 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). 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. Morphine: Morphine will be administered for post-operative pain in both the Cues and Non-Cues groups | 0 | 0 | 0 | 62 | 6 | 62 |
Not provided
Not provided
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| Post-op Day 2 |
|