Acute Post-operative PainPandaNCT01610882
Panda: Evaluation of a Smartphone-based Perioperative Pain Assessment Tool
A study testing Panda first followed by manual pain assessment and Manual first followed by Panda pain assessment in people with Acute Post-operative Pain, run by University of British Columbia at 1 site in Canada.
Trial summary
This study will evaluate Panda, a smartphone-based pain assessment tool. During a child's recovery from surgery, a Post-Anesthetic Care Unit nurse will assess their pain, which helps determine what medication they need. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Acute Post-operative Pain
- What is being tested?
- Panda first followed by manual pain assessment and Manual first followed by Panda pain assessment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteCanada
- Study dates
- May 2012to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Undergoing a surgical procedure for which there is an anticipated post-surgical pain model
- Age 4 - 18 years
- ASA I-III, not requiring admission to PICU
- Written parental/guardian informed consent and subject informed assent when required (subject age ≥ 7 years)
Who cannot join
- Children who have not undergone a surgical procedure (e.g. MRI, X-ray or endoscopy patients)
- Inability or refusal to provide informed consent/assent
- Developmental delay, neurological injury or psychomotor dysfunction
- Children who have a significant visual impairment or have undergone eye surgery
Trial locations and contacts
1 site in 1 country.
Canada1 site
British Columbia Children's Hospital Department of Anesthesia
Vancouver, British Columbia, V6H 3V4
About this study
This study will evaluate Panda, a smartphone-based pain assessment tool. During a child's recovery from surgery, a Post-Anesthetic Care Unit nurse will assess their pain, which helps determine what medication they need. Traditionally, this involves asking the child to rate their pain on a scale from 1 to 10, by moving a slider along a coloured scale or pointing to one of a series of faces on a piece of card. The Panda uses the same methods, but presents them on a smartphone screen. Our evaluation will ensure that the Panda gives the same pain scores as the traditional methods.
Read the detailed description
The purpose of this study is to ensure that Panda, a smartphone-based pain assessment tool, can be used effectively by children after surgery and that the pain scores it obtains agree with the scores obtained using traditional methods of pain assessment. In particular the aim is to show agreement (a) between pain scores obtained using Panda and pain scores obtained using the Faces Pain Scale-Revised for 4-12 year olds and (b) between pain scores obtained using Panda and pain scores obtained using the Coloured Analogue Scale (CAS) for 5-18 year olds.
We will recruit children between 4 and 18 years old, in general good health, who are scheduled for surgery. We will exclude any child who has a psychiatric diagnosis, developmental delay or brain injury, significant visual impairment or psychomotor dysfunction.
This study is taking place in the Post-anesthetic Care Unit (PACU) at BC Children's Hospital. We will recruit 200 children in total. The study procedures include the following:
Stage 1 - pre-clinical usability study: we will conduct a series of participatory design sessions with nurses in the PACU and with 20 children in the Surgical Day Care Unit (SDCU)
Stage 2 - clinical validation study: children will be asked to rate their pain using both the Panda and a traditional tool (which is used first will be decided randomly); during this stage, children will also be asked their opinion (e.g. which tool they preferred using and about any problems they experienced using either tool).
All scores will be recorded on the Panda device and extracted at the end of each day. No pain medication will be administered on the basis of a pain score obtained using the Panda.
Panda will be compared with the traditional method (FPS-R and CAS) within 3 different age groups (4-8, 8-12 and 12-18), using the following criteria: practicality, based on failure rates in obtaining pain scores from Panda compared with traditional method; preference for Panda compared with traditional method; agreement between the Panda score and the traditional score.
- Conditions
- Acute Post-operative Pain
- Being tested
- Panda first followed by manual pain assessment, Manual first followed by Panda pain assessment
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panda first followed by manual pain assessmentDevice
Panda is a smart-phone based application designed to assess post-operative pain; manual method involves use of CAS/FPS-R on paper. Panda will be used first, manual method 5 mins later.
Manual first followed by Panda pain assessmentDevice
Panda is a smart-phone based application designed to assess post-operative pain; manual method involves use of CAS/FPS-R on paper. Manual method will be used first, Panda 5 mins later.
| Study group | Role | What they receive |
|---|---|---|
| Panda first | Other | Panda evaluation of post-operative pain first, followed by manual method of pain assessment. Receives: Device: Panda first followed by manual pain assessment |
| Manual first | Other | Manual evaluation of post-operative pain first followed by Panda pain assessment. Receives: Device: Manual first followed by Panda pain assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance between the electronic and paper versions of the FPS-R and CAS pain scales
The study aims to measure concordance between the (a) pain scores obtained using Panda and pain scores obtained using the Faces Pain Scale-Revised for 4-12 year olds and (b) pain scores obtained using Panda and pain scores obtained using the Coloured Analogue Scale (CAS) for 5-18 year olds.
Measured: Up to 2 hours following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Post-operative PainStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Ansermino, University of British Columbia
- Investigators
- Mark Ansermino, Study director, UBC/Medicine, Faculty of/Anesthesiology, Pharmacology & TherapeuticsGillian Lauder, Principal investigator, UBC/Medicine, Faculty of/Anesthesiology, Pharmacology & Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01610882
- Sponsor's protocol ID
- H12-01273
- Acronym
- Panda
- Status last verified
- Oct 2017
- First submitted
- 29 May 2012
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Panda: Evaluation of a Smartphone-based Perioperative Pain Assessment Tool
- ClinicalTrials.gov ID
- NCT01610882
- Acronym / sponsor ID
- Panda / H12-01273
- Conditions
- Acute Post-operative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 4 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate Panda, a smartphone-based pain assessment tool. During a child's recovery from surgery, a Post-Anesthetic Care Unit nurse will assess their pain, which helps determine what medication they need. Traditionally, this involves asking the child to rate their pain on a scale from 1 to 10, by moving a slider along a coloured scale or pointing to one of a series of faces on a piece of card. The Panda uses the same methods, but presents them on a smartphone screen. Our evaluation will ensure that the Panda gives the same pain scores as the traditional methods.
Detailed description
The purpose of this study is to ensure that Panda, a smartphone-based pain assessment tool, can be used effectively by children after surgery and that the pain scores it obtains agree with the scores obtained using traditional methods of pain assessment. In particular the aim is to show agreement (a) between pain scores obtained using Panda and pain scores obtained using the Faces Pain Scale-Revised for 4-12 year olds and (b) between pain scores obtained using Panda and pain scores obtained using the Coloured Analogue Scale (CAS) for 5-18 year olds.
We will recruit children between 4 and 18 years old, in general good health, who are scheduled for surgery. We will exclude any child who has a psychiatric diagnosis, developmental delay or brain injury, significant visual impairment or psychomotor dysfunction.
This study is taking place in the Post-anesthetic Care Unit (PACU) at BC Children's Hospital. We will recruit 200 children in total. The study procedures include the following:
Stage 1 - pre-clinical usability study: we will conduct a series of participatory design sessions with nurses in the PACU and with 20 children in the Surgical Day Care Unit (SDCU)
Stage 2 - clinical validation study: children will be asked to rate their pain using both the Panda and a traditional tool (which is used first will be decided randomly); during this stage, children will also be asked their opinion (e.g. which tool they preferred using and about any problems they experienced using either tool).
All scores will be recorded on the Panda device and extracted at the end of each day. No pain medication will be administered on the basis of a pain score obtained using the Panda.
Panda will be compared with the traditional method (FPS-R and CAS) within 3 different age groups (4-8, 8-12 and 12-18), using the following criteria: practicality, based on failure rates in obtaining pain scores from Panda compared with traditional method; preference for Panda compared with traditional method; agreement between the Panda score and the traditional score.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Panda first | Other | Device: Panda first followed by manual pain assessmentPanda evaluation of post-operative pain first, followed by manual method of pain assessment. |
| Manual first | Other | Device: Manual first followed by Panda pain assessmentManual evaluation of post-operative pain first followed by Panda pain assessment. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Undergoing a surgical procedure for which there is an anticipated post-surgical pain model
- Age 4 - 18 years
- ASA I-III, not requiring admission to PICU
- Written parental/guardian informed consent and subject informed assent when required (subject age ≥ 7 years)
Key exclusion criteria (4 listed)
- Children who have not undergone a surgical procedure (e.g. MRI, X-ray or endoscopy patients)
- Inability or refusal to provide informed consent/assent
- Developmental delay, neurological injury or psychomotor dysfunction
- Children who have a significant visual impairment or have undergone eye surgery
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 |
|---|---|---|
| Panda first followed by manual pain assessmentPanda is a smart-phone based application designed to assess post-operative pain; manual method involves use of CAS/FPS-R on paper. Panda will be used first, manual method 5 mins later. | Device | Panda first |
| Manual first followed by Panda pain assessmentPanda is a smart-phone based application designed to assess post-operative pain; manual method involves use of CAS/FPS-R on paper. Manual method will be used first, Panda 5 mins later. | Device | Manual first |
Primary outcome
Concordance between the electronic and paper versions of the FPS-R and CAS pain scales
Time frame: Up to 2 hours following surgery
The study aims to measure concordance between the (a) pain scores obtained using Panda and pain scores obtained using the Faces Pain Scale-Revised for 4-12 year olds and (b) pain scores obtained using Panda and pain scores obtained using the Coloured Analogue Scale (CAS) for 5-18 year olds.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
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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.
Mark Ansermino study director
UBC/Medicine, Faculty of/Anesthesiology, Pharmacology & Therapeutics
Gillian Lauder principal investigator
UBC/Medicine, Faculty of/Anesthesiology, Pharmacology & Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Panda first followed by manual pain assessment and Manual first followed by Panda pain assessment in people with Acute Post-operative Pain, run by University of British Columbia at 1 site in Canada.
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 26 Oct 2017. 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 Canada. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Concordance between the electronic and paper versions of the FPS-R and CAS pain scales (time frame: Up to 2 hours following surgery). 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 26 Oct 2017.