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Completed

NCT Number: NCT01610882

Panda: Evaluation of a Smartphone-based Perioperative Pain Assessment Tool

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.

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Key information

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

British Columbia Children's Hospital Department of Anesthesia

Vancouver, British Columbia, V6H 3V4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Panda first followed by manual pain assessment

Device

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 assessment

Device

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Acronym: Panda

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 4, 2012
Registry last updated
Oct 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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