- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01610882
Panda: Evaluation of a Smartphone-based Perioperative Pain Assessment Tool (Panda)
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V6H 3V4
- British Columbia Children's Hospital Department of Anesthesia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Panda first
Panda evaluation of post-operative pain first, followed by manual method of pain assessment.
|
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.
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Other: Manual first
Manual evaluation of post-operative pain first followed by Panda pain assessment.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concordance between the electronic and paper versions of the FPS-R and CAS pain scales
Time Frame: Up to 2 hours following surgery
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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.
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Up to 2 hours following surgery
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mark Ansermino, UBC/Medicine, Faculty of/Anesthesiology, Pharmacology & Therapeutics
- Principal Investigator: Gillian Lauder, UBC/Medicine, Faculty of/Anesthesiology, Pharmacology & Therapeutics
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H12-01273
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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