Pediatric Pain Assessment in the Emergency Department
Conditions: Pain, Acute Pain
Sponsor: Wake Forest University Health Sciences

 
 
Pediatric Pain Assessment in the Emergency Department 
NCT03157882 
October 13, 2017 
 
Primary Investigator: 
 
Simone L. Lawson, MD 
 
 
 
 
 
Pediatric Emergency Medicine Fellow 
 
 
 
 
 
Department of Emergency Medicine 
 
 
 
 
 
Division of Pediatric Emergency Medicine 
 
 
 
 
 
1000 Blythe Boulevard 
 
 
 
 
 
MEB Floor 3 
 
 
 
 
 
Charlotte, NC 28203 
 
Co-Investigators: 
Stacy L. Reynolds, MD 
Department of Emergency Medicine 
Division of Pediatric Emergency Medicine 
PO Box 32861 
Charlotte, NC 28232-2861 
Phone: 704.355.3181 
 
Michael Runyon, MD 
Research Director 
Department of Emergency Medicine 
PO Box 32861 
Charlotte, NC 28232-2861 
Phone: 704.355.7205 
 
Melanie Hogg, CCRA 
Department of Emergency Medicine 
1000 Blythe Boulevard 
Cannon Research Center, Room 315 
Charlotte, NC 28203 
Phone: 704.355.4288 
 
Charity G. Moore Patterson, PhD, MSPH 
Director of Research in Biostatistics 
Dickson Advanced Analytics 
1540 Garden Terrace 
Charlotte, NC 28203 
Phone: 704.355.9875 
 
 
 

 
 
Purpose:  
To examine how pediatric pain scales are used in clinical practice in a pediatric emergency 
department (ED).  Specifically we will examine the use of Wong-Baker FACES ® Pain Rating 
Scale (WBF) and Faces Pain Scale – Revised (FPS-R) by ED nurses, as well as the correlation 
of results with the children’s subjective descriptions of pain before and after an analgesic 
intervention as well as parental estimates of their children’s pain.  We will determine if a child’s 
successful use of these scales can be predicted by evaluating his/her neurocognitive 
development. 
Background: 
“Most children five years and older can provide meaningful self-reports of pain if they are 
provided with age appropriate tools and training.”1 Self-report is the desired method of data 
collection.2,3   Face scales provide an ordinal self-report of pain, and the literature suggests that 
they are the preferred method of pain reporting by children.2 
Both the WBF and the FPS-R have been studied extensively in children with chronic pain, post-
operatively, and those experiencing procedural pain; however, data for their use in assessing 
acute pain while in the ED is limited.  It is imperative that pain be assessed accurately, as it is 
the most common reason for presentation to the ED.  However, it is also important because 
often we draw conclusions about the efficacy of an intervention based on the results of these 
pain scales. 
Both the WBF and FPS-R are designed to be delivered with a specific script.  However, in 
practice these scripts are rarely used as intended, and caregivers’ perception of the child’s pain 
is often used as a surrogate for self-report.  There have been no studies determining whether a 
caregiver’s rating of his/her child’s pain using the WBF or FPS-R accurately reflects the child’s 
self-report; however, the practice of relying on the parents’ assessment of their child’s pain has 
been demonstrated in some studies to poorly correlate with the patient’s own perceived pain 
intensity.4  
The WBF has an intended age range of 3-18 years, while the FPS-R is intended for 4-12 year 
olds.5  There are a limited number of studies that have examined whether children can be 
screened to predict their ability to use these scales, but none have used validated 
developmental screening tools.  There are cognitive and social abilities that are necessary to 
self-report pain.6 However, evidence is limited as to whether screening for these skills can 
accurately predict children that will successfully use self-report pain scales.   
 
Phase 1 – Primary Aim: 
To examine how pain scales are administered by clinicians at the bedside in a pediatric ED and 
how it impacts the recorded pain score. 
Hypothesis:  There will be significant variability in how the WBF and FPS-R are administered in 
actual practice, including inconsistency in taking into consideration the caregiver’s perception of 
the child’s pain. 
Rationale: Both the WBF and FPS-R were validated with specific scripts; however, it is 
unknown if the normal variation in application of the scales diminishes their validity. To 

 
 
determine the magnitude of this problem, we will complete an initial survey of patients with 
painful conditions and observe how the WBF is used in actual practice.  Specifically, we will 
determine how often the recommended script is followed, but we will also determine if there are 
common variations from the recommended script.  We will also evaluate how often a caregiver’s 
perception of the child’s pain is considered when completing the self-report scales.  
Methods Summary: Prospective, observational, qualitative examination of bedside pain 
assessment in the pediatric ED. 
The frequency and nature of deviations from the pain scale script at the initial pain assessment 
in triage will be directly observed by the PI and audio recorded for future word-for- word analysis 
of deviations from the script. The audio recordings will be used to make transcripts devoid of 
PHI for this purpose. Field notes will be taken by the PI in order to provide context and other key 
observations not captured by the audio recordings. Variations from the transcript will be 
identified and quantified. Field notes, coupled with quantitative data of the frequency of 
deviations from the pain scale script and their location within the script will be analyzed by 
qualitative methods of interview analysis described in the Qualitative Analysis Guide of Leuven, 
modified to analyze our observations.7 Briefly, the data of the script deviations and field notes 
will be conceptualized, whereby the data will be filtered and the most important data clustered 
into concepts to prepare for analysis. The transcripts and field notes will be re-read with the 
concepts in mind and refined. The individual transcripts will be assessed by the constant 
comparative method with review of common themes and the identification of new themes. 
Concepts will be integrated into a conceptual framework relating to the hypothesis and 
discussed with the research team to obtain consensus prior to generating a final summary of 
concepts. 
 
Phase 2 – Primary Aim #1: 
To determine if level of neurocognitive development impacts responsivity of the WBF and FPS-
R (whether the measure is able to identify changes in pain over time that are clinically important 
to patients) when used in the pediatric ED with children presenting with acute pain.  
Hypothesis: Patients with at or above expected cognitive development will exhibit improved 
responsivity when using the WBF and FPS-R compared to children with lower than expected 
cognitive development.  Those who can successfully complete behavioral tasks such as 
matching and grouping will exhibit improved responsivity when using the WBF and FPS-R 
compared to children who cannot complete such tasks successfully. 
 
Phase 2 – Primary Aim #2: 
To determine the cognitive age equivalent at which children presenting to the emergency 
department with acute pain can use the WBF and FPS-R accurately to self-report their level of 
pain at two separate time points during their ED evaluation. 
Hypothesis: Children with a cognitive age equivalent of at least five years old will more reliably 
use the WBF and FPS-R to self-report acute pain when presenting to the emergency 
department 

 
 
Rationale: Multiple studies have compared children’s ability to use pain scales based on age, 
and both the WBF and FPS-R are conventionally believed to be appropriate for children once 
they are four years old.  However, age is used as a proxy for developmental level; not all four 
year old children have the developmental and cognitive skills to quantify and report their pain.  
Whether children have the skill set to complete a self-report of pain is variable until 
approximately the age of five years.  This study would serve to more clearly classify the level of 
cognitive development needed to use the pain scales effectively. 
Methods Summary: Prospective, observational study to determine if there is correlation 
between neurocognitive development and responsivity when using the WBF and FPS-R as well 
as the minimum cognitive age equivalent needed to effectively use the WBF and FPS-R. Initial 
and repeat WBF and FPS-R self-report scores will be compared at two points during the ED 
evaluation of patients presenting with acute pain. The change in the WBF and FPS-R pain 
scores will be compared to the subjective self-reports of change in pain.  Children will complete 
the BRIGANCE ® Early Childhood Screens III to determine whether they are at, above, or 
below the expected cognitive development for their age.  Children with at or above expected 
cognitive development for their age will be compared to those with lower than expected 
cognitive development.  Children will also complete a series of tasks aimed to assess ability to 
successfully use the WBF and FPS-R (Appendix 2).  Children that complete all tasks 
successfully will be compared to those who do not.  The BRIGANCE will also be used to 
determine the cognitive age equivalent for each subject.  We will determine the minimum 
cognitive age equivalent associated with accurate use of the WBF and FPS-R, defined as a self-
report that matches the subjective report of change in pain. 
 
Phase 2 – Secondary Aim #1: 
To determine whether the WBF and FPS-R exhibit convergent validity (degree to which they 
produce similar results) when used with children presenting to the emergency department with 
acute pain 
Hypothesis: The WBF and FPS-R will demonstrate convergent validity when used to measure 
acute pain in children presenting to the emergency department 
Rationale: Both the WBF and FPS-R have been studied for their use in obtaining self-reports of 
pain in children, and overall have been determined to be two of the preferred methods of pain 
assessment in pediatric patients.  Although each has been compared to other methods of pain 
measurement, the two have not been compared to each other.  If the two studies were proven 
to have convergent validity, it would strengthen the evidence that these methods should be the 
preferred tools for assessing pain in children. 
Methods Summary: Prospective, observational study to determine the convergent validity of 
the WBF and FPS-R for children presenting to the ED with acute pain.  The initial and repeat 
WBF and FPS-R self-report scores will be compared in patients presenting to the ED with acute 
pain. 
 
 

 
 
Phase 2 – Secondary Aim #2 
To determine if there is inter-rater reliability between patients presenting to the pediatric ED with 
acute pain and their caregivers when using the WBF and FPS-R at two separate time points 
during their ED evaluation 
Hypothesis: There will be low inter-rater reliability between patients and their caregivers using 
the WBF and FPS-R. 
Rationale:  Caregiver perception of a pediatric patient’s pain is often used as a substitute for 
the patient’s self report of pain; however, studies are limited to show that caregivers are able to 
predict children’s pain level accurately when in the acute care setting. 
Methods Summary:  Prospective, observational study to determine the inter-rater reliability 
between patients and their caregivers when using the WBF and FPS-R.  The initial and repeat 
WBF and FPS-R self-report scores will be compared to caregivers’ initial and repeat WBF and 
FPS-R ratings in patients presenting to the pediatric ED with acute pain. 
 
Identification of Subjects 
Participants will come from a convenience sample of children presenting to the ED.  Triage 
nurses and ED providers will be aware of the study and notify the PI or designee by phone if 
patients may qualify for the study.  The PI and designees will also have access to the ED track-
board and can screen for possible participants. 
Inclusion Criteria 
Patients > 3 years and <7 years six months old 
Chief complaint of pain or painful condition (Phase 1 only) 
Pain score > 4/10 (Phase 2 only) 
Caregiver speaks English or Spanish 
 
Exclusion criteria 
Altered mental status 
History of traumatic brain injury (TBI) 
History of developmental delay 
History of Autism 
History of chronic pain, defined as persistent or recurrent pain in children with chronic 
health conditions8  
Non-verbal patients 
 
 
 
 
 
 
 

 
 
Outcome Measures: 
Phase 1 - Primary Aim 
Rate of intended script use in pain scale delivery 
Review of themes during nursing pain assessment 
Consistency in delivery of WBF by nursing 
 
Phase 2 - Primary  
Neurocognitive development score 
BRIGANCE ® score 
Initial WBF score 
Repeat WBF score 
Initial FPS-R score 
Repeat FPS-R score 
Anchor report of pain (a lot better, a little better, the same, a little worse, a lot worse) 
 
Phase 2 - Secondary 
Initial WBF score (patient and caregiver) 
Repeat WBF score (patient and caregiver) 
Initial FPS-R score (patient and caregiver) 
Repeat FPS-R score (patient and caregiver) 
 
Study Definitions: 
 “Caregiver” will refer to an adult who is able to provide consent for treatment and provides 
regular care for the child. 
“Chronic pain” includes persistent (ongoing) and recurrent (episodic) pain in children with 
chronic health conditions. 
Convergent validity evaluates the degree to which two different scales that are supposed to 
measure the same thing produce similar results. 
“Repeat pain score” will be completed approximately 20 minutes after the initial pain score, or if 
administered, approximately 20 minutes after analgesic intervention. 
Responsivity is the degree to which a test behaves in a manner that is consistent with what the 
test is purported to measure.  It determines whether the measure is able to identify changes in 
pain over time that are clinically important to patients. 
 
Phase 1 Study Protocol: 
1. Once the subject is identified, the caregiver will provide verbal consent for participation 
in the study. 
2. After verbal consent is obtained, the primary investigator will observe and audio record 
nursing’s assessment of the patient’s pain and complete the observation checklist 
(Appendix 1). 
 

 
 
Phase 2 Study Protocol: 
1. Once the subject is identified, the caregiver will provide written consent for participation 
in the study (if a self-report pain score was not collected in the triage process, patients 
with pain or a potentially painful condition will have their pain assessed using an age 
appropriate self-report pain scale by the PI or designee). 
2. Early in the ED visit, the investigator or designee will help the patient complete Part One 
of the Patient Survey (Appendix 3), which includes the WBF, and the FPS-R. 
3. The caregiver will also complete Part One of the Caregiver Survey (Appendix 4). 
4. Subjects will be treated per usual care by an MD/ACP. 
5. The investigator or designee will help the patient complete Part Two of the Patient 
Survey (Appendix 3), which includes the WBF and the FPS-R.  This will occur 
approximately 20 minutes after analgesic administration, if it was ordered. 
6. The caregiver will also complete Parts Two and Three of the Caregiver Survey 
(Appendix 4). 
7. If the patient indicates in Part Two of the Patient Survey that he/she feels better, the 
investigator or designee will complete a brief neurocognitive skills assessment 
(Appendix 2) as well as the BRIGANCE ® Early Childhood Screens III with the patient. 
8. If the patient indicates that he/she feels the same or worse on Part Two of the Patient 
Survey the treating MD/ACP will be notified. 
9. The patient will be reassessed by the PI or designee at least 20 minutes after analgesic 
administration, if it was ordered, or after a reasonable time period if no analgesic 
medication was ordered. 
10. On reassessment, if the patient says that he/she is willing to participate, the PI or 
designee will complete a brief neurocognitive skills assessment (Appendix 2) as well as 
the BRIGANCE ® Early Childhood Screens III with the patient.  If the patient is not 
willing to participate, study assessments will cease. 
 
Statistical Analysis: 
Phase 1 
Sample size: 30 
Rate of compliance with intended script and rate of consideration of caregiver perception will be 
reported as percentages.  Qualitative data will also be reviewed by the PI for the emergence of 
themes. 
 
Phase 2 
Sample size: approximately 250 
Responsivity will be measured by correlating the change in the WBF and FPS-R scores before 
and after analgesic intervention with the anchor change in pain score (a lot better, a little better, 
the same, a little worse, a lot worse). Pearson correlations will be estimated between each 
change score and the anchor score. In addition, we will use ANOVA to test the difference in 
mean pain change among the children reporting “a lot better”, “a little better”, and “the same”. 
For the scales to be considered responsive, we would need to see significant reductions for the 

 
 
children reporting “a lot better”, minimal to no reduction for those reporting “the same”, and 
increase in pain for those reporting “worse”. We will need a relatively large number of children in 
each category (a lot better, a little better, the same) to be able to test for differences (at least 30 
per group). We will use Fisher’s z-transformation to test if level of neurocognitive development 
impacts responsivity. Levels of neurocognitive development will be defined as at or above 
expected or lower than expected. The Fisher’s z-transformation formally tests if the correlations 
between two measures (change in pain and anchor rating) differ between two groups. Here we 
assume we will have significant variability in change scores and in the anchor ratings to conduct 
these correlations and the formal test. We would need at least 56 children in each 
neurogcognitive development group (expected or above versus below). If the variability is 
limited in that most children report improvement and few report same or worsening, we will test 
for responsivity differences using a two-way ANOVA where the two factors are self reported 
anchor response (“better”, “same” or “worse) and neurocognitive level (expected or above 
expected vs below expected). The outcomes are the change in the WBF and the change in the 
FPS-R. The test of interest will be the two way interaction between the anchor and the 
neurocognitive development level. The BRIGANCE also provides the developmental age for 
each child which can be compared to their actual age. We will test if this difference is significant 
using a paired t-test. We will also explore the age where responsivity worsens by conducting 
similar analyses but stratified by actual age (each year) and developmental age. Given the 
proposed analysis, we will need at least 50 children for each cognitive age (3, 4, 5, 6, and 7 
years) assuming at least 10 fall into the “a lot better”, “a little better”, “the same” categories for 
the anchor pain question.  
Convergent validity will be assessed by determining both Pearson’s correlation and agreement 
using the Bland-Altman method between the WBF and FPS-R scores before and after analgesic 
intervention.  We will compare Pearson correlations using Fisher r-to-Z transformation. 
Inter-rater reliability will be determined by calculating intra-class correlation coefficients (ICCs) 
between the parent and the child reports at the same time points. 
This analysis will be completed with the biostatistics team under the direction of CORE (Center 
for Outcomes of Research and Excellence). 
 
 

Investigator Initials: _______________  Date: _______________ 
Appendix 1 – Qualitative Assessment (Phase 1 Primary Aim) 
Subject # _________ 
Observed Pain Assessment 
Start Time: ______________ 
 
End Time: _____________ 
RN: ________________ 
 
Initial pain scale used 
Wong Baker FACES 
 
Numerical 
 
Other  
 
 
Initial phrasing of question 
_____________________________________________________________________________________ 
How is the question framed? 
 
Zero 
 
 
 
 
 
Ten 
No pain 
 
 
 
 
Worst pain experienced 
No hurt 
 
 
 
Worst pain possible 
Other ______________  
 
Other _______________ 
 
 
 
Example given for 10/10? 
 
 
 
 
Yes 
 
No 
Patient’s initial response  _________ 
Time to give answer  __________ 
Is the question rephrased? 
 
 
 
 
 
Yes 
 
No 
Final scale used 
 
Wong Baker FACES 
 
Numerical 
 
Other  
Is parent asked for confirmation? 
 
 
 
 
Yes 
 
No 
Does the parent rate the child’s pain? 
 
 
 
Yes  ___/10 
No 
Is parent asked for their perception?  
 
 
 
Yes 
 
No 
Other tasks completed during assessment?  
 
 
Yes 
 
No 
 
Vitals 
 
 
Medication 
Is “happy because there is no pain/hurt” mentioned? 
 
Yes 
 
No 
Is “you do not have to be crying” mentioned? 
 
 
Yes 
 
No 
Final score documented  _________ 
Does the RN believe the child understands the scale? 
 
Yes 
 
No 
Does the caregiver believe the child understands the scale? 
Yes 
 
No

 
Appendix 2 – Neurocognitive Assessment (Phase 2 Primary Aims #1 and #2)
 
Part I: Neurocognitive Skills Assessment 
Classification 
Children will be asked to “put together things that are alike” to determine their ability to 
classify objects.  First they will be presented with a total of nine squares of paper of equal 
size (three red, three blue, and three yellow) and will be expected to group them by color.  
They will then be presented with nine faces from the WBF (three of 0/10, three of 4/10, and 
three of 10/10) and asked to group similar faces.  Finally, they will be presented with nine 
faces from the FPS-R (three of 0/10, three of 4/10, and three of 10/10) and asked to group 
similar faces.   Final score will be 0-3 points, with one point assigned for each group properly 
classified. 
 
Seriation 
Participants will be asked to put a series of six squares with increasing size in order from 
smallest to largest.  They will then be asked to put the six individual faces from WBF in order 
from least pain to most pain.  They will repeat the task with the six individual faces from FPS-
R.  Final score will be 0-3, with one point assigned for each group properly ordered. 
 
Magnitude of Pain 
Using pictures and scenarios from the Charleston Pediatric Pain Pictures (CPPP),9 
participants will be asked whether the pictures show “no hurt,” “a little hurt,” or “a lot of hurt” 
and will be assigned one point for each scenario properly classified for a total of 0-3 points. 
 
Matching 
Using pictures from the CPPP, participants will assign face scale levels of pain to a no-pain, 
a medium-pain, and a severe-pain picture using the WBF (0/10, 4/10, and 10/10) and the 
FPS-R (0/10, 4/10, and 10/10).  They will receive one point for each scenario correctly 
matched for a total of 0-6 points. 
 
Reverse Matching 
Participants will be shown faces from the WBF and FPS-R (0/10, 4/10, and 10/10) and asked 
to select a pain scenario from the CPPP to match.  They will receive one point for each 
scenario properly matched for a total of 0-6 points. 
 
Part 2: BRIGANCE ® Early Childhood Screens III 
 

Investigator Initials: _______________  Date: _______________ 
Appendix 3 – Patient Survey (Phase 2 Primary and Secondary Aims) 
Part One 
Time: ________ 
 
1. Does anything hurt on you right now? 
 
 
 
2. Faces Pain Scale-Revised reported score: 
 
 
3. Wong-Baker FACES ® reported score: 
 
 
 
 
 
Medication: ___________________________ 
 
Time administered: ___________ 
 
 
 
 

Investigator Initials: _______________  Date: _______________ 
Part Two 
Time: _______ 
1. Do you feel better, worse, or the same? 
Better (go to Section A) 
Worse (go to Section B) 
Same (go to Section C) 
 
Section A 
Do you feel a little bit better or a lot better? 
A little bit 
 
 
A lot 
 
 
Does anything hurt on you right now? 
Yes 
 
 
No 
What hurts on you right now?  ______________________________________ 
 
Section B 
Do you feel a little bit worse or a lot worse? 
A little bit 
 
 
A lot 
What hurts on you right now? ______________________________________ 
 
 
☐ MD notified 
Section C 
Does anything hurt on you right now? 
Yes 
 
 
No 
What hurts on you right now? _________________________________ 
 
 
☐ MD notified 
2. Faces Pain Scale-Revised reported score: 
 
 
3. Wong-Baker FACES ® reported score: 
 

Investigator Initials: _______________  Date: _______________ 
Appendix 4 – Caregiver Survey (Phase 2 Secondary Aim #2) 
Part One 
Thank you for agreeing to participate in this study of pain scales used in children.  Your 
responses will help us make sure we are doing the best job we can to address your child’s pain.  
Please do not ask your child about his/her pain while you answer these questions. 
What do you believe is hurting on your child? 
___________________________________________________________________________ 
 
These faces show how much something can hurt.  The face on the far-left shows no pain. 
The faces show more and more pain up to the far-right.  It shows very much pain. 
Please circle the face that shows how much you think your child hurts right now. 
 
 
Each face below is for a person who has no pain, or some, or a lot of pain.  Face 0 
doesn’t hurt at all. Face 2 hurts just a little bit. Face 4 hurts a little bit more.  Face 6 hurts 
even more. Face 8 hurts a whole lot. Face 10 hurts as much as you can imagine, although 
you don’t have to be crying to have this worst pain. 
Please circle the face that represents your child’s pain right now. 
 
 

Investigator Initials: _______________  Date: _______________ 
Part Two 
Your child has received medications to help lessen his/her pain.  Please answer the following 
questions about your child and his/her level of pain right now. 
Please do not ask your child about his/her pain while you answer these questions. 
 
These faces show how much something can hurt.  The face on the far-left shows no pain. 
The faces show more and more pain up to the far-right.  It shows very much pain. 
Please circle the face that shows how much you think your child hurts right now. 
 
 
Each face below is for a person who has no pain, or some, or a lot of pain.  Face 0 
doesn’t hurt at all. Face 2 hurts just a little bit. Face 4 hurts a little bit more.  Face 6 hurts 
even more. Face 8 hurts a whole lot. Face 10 hurts as much as you can imagine, although 
you don’t have to be crying to have this worst pain. 
Please circle the face that represents your child’s pain right now. 
 
 
 
 

Investigator Initials: _______________  Date: _______________ 
Do you think your child is in less pain than when you last rated his/her pain in Part One?           
(Circle your answer) 
 
 
Yes 
 
No 
 
If yes, what makes you believe his/her pain is less`? 
______________________________________________________________________ 
______________________________________________________________________ 
 
If no, what makes you think his/her pain is not less? 
______________________________________________________________________ 
______________________________________________________________________ 
 
 
 

Investigator Initials: _______________  Date: _______________ 
Part Three 
If you do not feel that your child’s pain has improved, please notify a provider at this time. 
Please answer the following questions about your child’s ability to report his/her pain. 
 
Do you think that your child would understand the pain scales you used to rate his/her 
pain? 
(Circle your answer) 
 
 
Yes 
 
No 
 
 
Do you think your child can accurately rate the level of his/her pain? 
(Circle your answer) 
 
 
Yes 
 
No 
 
What do you think is the most painful experience your child has had up to this point? 
____________________________________________________________________________ 
Has your child ever had surgery? 
____________________________________________________________________________ 
Has your child ever had stiches? 
____________________________________________________________________________ 
Has your child ever had a broken bone/fracture? 
____________________________________________________________________________ 
 
 

 
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