NCT01610882

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 4, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

1.2 years

First QC Date

May 29, 2012

Last Update Submit

October 24, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 2 hours following surgery

Study Arms (2)

Panda first

OTHER

Panda evaluation of post-operative pain first, followed by manual method of pain assessment.

Device: Panda first followed by manual pain assessment

Manual first

OTHER

Manual evaluation of post-operative pain first followed by Panda pain assessment.

Device: Manual first followed by Panda pain assessment

Interventions

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.

Panda first

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.

Manual first

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

British Columbia Children's Hospital Department of Anesthesia

Vancouver, British Columbia, V6H 3V4, Canada

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Mark Ansermino

    UBC/Medicine, Faculty of/Anesthesiology, Pharmacology & Therapeutics

    STUDY DIRECTOR
  • Gillian Lauder

    UBC/Medicine, Faculty of/Anesthesiology, Pharmacology & Therapeutics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

May 29, 2012

First Posted

June 4, 2012

Study Start

May 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

October 26, 2017

Record last verified: 2017-10

Locations