Postoperative PainPCA CuesNCT02456909
Patient Controlled Analgesia Pump Cues on Patient Satisfaction
A study testing Morphine in people with Postoperative Pain, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
To examine whether providing patients with a cue to the availability of pain medication affects patient satisfaction, patient anxiety, PCA efficacy, and safety. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Morphine
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to 3 Oct 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Prior experience with PCA
- Cognitive delay precluding independent use of the PCA button
- Current use of anxiolytics or antidepressants
- Patients receiving epidural analgesia
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53201
About this study
Official title: The Effect of Patient Controlled Analgesia Pump Cues on Patient Satisfaction
To examine whether providing patients with a cue to the availability of pain medication affects patient satisfaction, patient anxiety, PCA efficacy, and safety.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- Patient-Controlled Analgesia pump with Cues, Patient-Controlled Analgesia pump without Cues, Morphine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-Controlled Analgesia pump with CuesDevice
The end of the lockout period will be cued via the PCA pump
Patient-Controlled Analgesia pump without CuesDevice
The PCA pump will be programmed such that no cues will be provided to the end of the lockout period.
MorphineDrug
Morphine will be administered for post-operative pain in both the Cues and Non-Cues groups
| Study group | Role | What they receive |
|---|---|---|
| Cues | Experimental | The PCA pump will be programmed to provide a cue to the end of the lockout period. Receives: 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). Receives: Device: Patient-Controlled Analgesia pump without Cues; Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction Questionnaire
Patient satisfaction with their PCA pump. Satisfaction was measured on a 0 to 10 scale, with higher numbers indicating greater satisfaction.
Measured: Up to 72 hours
Secondary outcomes (2)
Opioid Consumption (Total Amount of Opioid Consumed Post-operatively)
Total amount of opioid consumed post-operatively in mg/kg/hour.
Measured: Post-op Days [POD] 0 - 2, up to 72 hours
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.
Measured: Up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study startApr 2015
- Primary completion3 Oct 2019
- Study completion3 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital and Health System Foundation, Wisconsin
- Responsible party
- Principal investigator, Keri Hainsworth, Medical College of Wisconsin
- Investigators
- Keri R. Hainsworth, PhD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02456909
- Sponsor's protocol ID
- NICU_RCT
- Acronym
- PCA Cues
- Status last verified
- Aug 2021
- First submitted
- 27 Apr 2015
- Last updated
- 8 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Patient Controlled Analgesia Pump Cues on Patient Satisfaction
- ClinicalTrials.gov ID
- NCT02456909
- Acronym / sponsor ID
- PCA Cues / NICU_RCT
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Children's Hospital and Health System Foundation, Wisconsin
- Study start
- Apr 2015
- Primary completion
- 3 Oct 2019 (actual)
- Study completion
- 3 Oct 2019 (actual)
- First posted
- 29 May 2015 (estimated)
- Results
- Posted 8 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To examine whether providing patients with a cue to the availability of pain medication affects patient satisfaction, patient anxiety, PCA efficacy, and safety.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cues | Experimental | Device: Patient-Controlled Analgesia pump with Cues, Drug: MorphineThe PCA pump will be programmed to provide a cue to the end of the lockout period. |
| No Cues | Placebo comparator | Device: Patient-Controlled Analgesia pump without Cues, Drug: MorphineThe PCA pump will be programmed such that no cues will be provided to the end of the lockout period (current standard of care). |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Prior experience with PCA
- Cognitive delay precluding independent use of the PCA button
- Current use of anxiolytics or antidepressants
- Patients receiving epidural analgesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient-Controlled Analgesia pump with CuesThe end of the lockout period will be cued via the PCA pump | Device | Cues |
| Patient-Controlled Analgesia pump without CuesThe PCA pump will be programmed such that no cues will be provided to the end of the lockout period. | Device | No Cues |
| MorphineMorphine will be administered for post-operative pain in both the Cues and Non-Cues groups | Drug | Cues, No Cues |
Primary outcome
Patient Satisfaction Questionnaire
Time frame: Up to 72 hours
Patient satisfaction with their PCA pump. Satisfaction was measured on a 0 to 10 scale, with higher numbers indicating greater satisfaction.
2 secondary outcomes
Opioid Consumption (Total Amount of Opioid Consumed Post-operatively)
Time frame: Post-op Days [POD] 0 - 2, up to 72 hours
Anxiety (State Anxiety on POD 1 and POD 2)
Time frame: Up to 72 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keri R. Hainsworth, PhD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morphine in people with Postoperative Pain, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction Questionnaire (time frame: Up to 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.