EVALUATION OF THREE PAIN ASSESSMENT SCALES FOR

NEONATES AT THE MEDICAL CITY

NEONATAL INTENSIVE CARE UNIT
Miki Yamamoto-Balin
The Medical City
Pasig City, Philippines

Objective: The study aims to assess the inter-observer reliability and feasibility
of three neonatal pain scales among NICU residents, nurses and midwives.
Design: This is a prospective study.
Methods: Phase I - Pediatric Residents, Neonatal Nurses and Midwives at The
Medical City Neonatal Intensive Care Unit participated a Pain Scale Training
Seminar. Videos of 8 neonates undergoing the heel-prick procedure were
assessed using the Crying, Requires Oxygen Saturation, Increased Vital Signs,
Expression, Sleeplessness (CRIES) Scale, Neonatal Infant Pain Scale (NIPS),
and Face, Legs, Activity, Cry and Consolability (FLACC) Scale. Thereafter,
participants were asked to evaluate the three pain scales based on ease-of-use.
Preliminary inter-observer reliability was determined based on the data collected.
Phase II Two (2) Pediatric Residents used the 3 pain scales to assess, at
bedside, 30 healthy neonates undergoing heel-prick procedure at the NICU.
Inter-observer reliability was studied.
Results: Phase I - All 3 pain scales showed agreement among observers.
Based on the comparison of the mean scores of observers, there was no
significant difference noted as proven by all p values >0.05. As compared to the
CRIES Scale and FLACC Scale, the Neonatal Infant Pain Scale was chosen as
the easiest pain assessment tool to use at the NICU with 88.9% acceptability.
Phase II - The NIPS and CRIES scale scores given by 2 residents who observed
the neonates at bedside showed moderate agreement with a Kappa of 0.469 and
0.441 respectively. Scores using the FLACC scale showed fair agreement with a
Kappa of 0.221. NIPS had the best rate of agreement at 63.3% as compared to
the CRIES and FLACC scale with 50% and 40%, respectively.
Conclusion: The 3 pain scales had comparable inter-observer reliability among
residents, nurses and midwives. Regarding feasibility, the Neonatal Infant Pain
Scale was assessed as the easiest-to-use pain assessment tool at the NICU.
Bedside assessment done by 2 residents using the NIPS and CRIES scale
showed moderate agreement. The NIPS had the best rate of agreement at
63.3%.

I. BACKGROUND OF THE STUDY

Every parent wants the best quality of care for their newborn. The Neonatal
Intensive Care Unit (NICU), being the 'first home' of their baby, is expected to deliver
routine newborn care and provide a protective environment for their offspring. The
prevention of pain in neonates is an expectation of parents.1 However, it cannot be
denied that infants at the NICU are subjected to potentially painful and stressful
interventions.2 Neonates who undergo routine newborn care procedures such as heelprick, venipuncture, and intravenous catheter insertion are exposed to relative intensity
of pain. Even the most trivial diaper change showed an increased pain response in
neonates based on the study by Morelius et al.2 Neonates feel pain and require the
same level of pain assessment as adults.
The Joint Commission on Accreditation of Healthcare Organizations (JCAHO)
and the American Academy of Pediatrics underscore the importance of pain assessment
and management.3,4 JCAHO recommends the implementation of a standardized pain
assessment and management, recognized as a basic patient right. Despite the growing
number of available neonatal pain assessment tools, these are not implemented
universally in healthcare institutions. Thus, neonatal pain remains under- or untreated. 4
The Neonatal Intensive Care Unit (NICU) of The Medical City (TMC) has yet to
formulate an effective pain management program for neonates. This program can start
with a feasible and reliable pain scale. Establishment of a pain scale that is easy-to-use
and can score pain intensity with consistency will encourage compliance and pave the
way towards the implementation of an effective pain management program in the NICU.
This would ease the burden and potentially uplift the quality of life of neonates
undergoing painful procedures. At present, no studies were found comparing neonatal
pain scales in the local setting.
In this study, the three valid neonatal pain scales were evaluated based on
feasibility and inter-observer reliability. Feasibility refers to the ease with which clinicians
can apply the instrument in the clinical setting.5 On the other hand, reliability refers to the
degree of agreement between different observers.5 This will determine the most
appropriate pain assessment scale to be implemented at the NICU.
Hopefully, the establishment of a reliable and feasible pain assessment scale at
TMC-NICU will pave the way for further studies regarding pain management strategies.

II. REVIEW OF RELATED LITERATURE

The International Association for the Study of Pain defined pain as an
unpleasant sensory and emotional experience associated with actual or potential tissue
damage or described in terms of such damage.6 Neonates are not exempted from this
experience, thus, it is the responsibility of health professionals to recognize, assess and
treat any type of pain to ensure humane management and alleviate suffering of
neonates.
According to Haouari and colleagues, healthy, term newborns in the nursery
experience at least one heel prick for the Newborn Screening Test during the 1st week of
life.7 At TMC-NICU, almost 100% of neonates undergo one heel prick (Newborn
Screening Test) and 2 intramuscular injections (routine Vitamin K and Hepatitis B
vaccine injections) prior to discharge. Healthy neonates at the nursery undergo heel
prick, venipuncture, and intramuscular injections. Though considered to be minor
procedures, these are actual sources of pain that are frequently overlooked.
A dilemma in proper pain assessment and management is that common
misconceptions regarding newborn pain based on old school knowledge still abound.
These include the false premise that (1) newborns do not perceive pain; (2) newborns do
not remember pain, or if they do, it has no adverse effects; (3) it is too dangerous to
administer anesthesia or postoperative analgesia to newborn infants.8
Literature states that neonates respond to noxious stimulation as early as the
2nd trimester. At this time, afferent pathways and spinal cord connect with peripheral
targets. There is also development of rostral projections to the thalamus and cortex.
Studies show that neonates are more hypersensitive to pain as compared to adults since
a lesser amount of stimuli is needed to elicit the reflex withdrawal response.9 The
immaturity of sensory processing within the newborn spinal cord leads to lower
thresholds for excitation and sensitization. This potentially maximizes the central effects
of these tissue-damaging inputs. Fitzgerald also states that the plasticity of the sensory
connections in the neonatal period means that early damage in infancy can lead to
prolonged structural and functional alterations in pain pathways.9
'Pain experienced early in life by term infants may exaggerate affective and
behavioral responses during subsequent painful events.'10 A study done by Johnston CC
et al showed that neonates who were exposed to numerous painful and noxious stimuli

between post-conceptual weeks 28 and 32 showed different behavioral and

physiological responses to pain compared with neonates of a similar post-conceptual
age who had not had such experiences.11 Taddio and colleagues found that there was
an exaggerated response to the pain associated with routine immunization in term
newborn males previously exposed to circumcision without analgesia.10 Aside from
causing distress and delayed recovery, pain in infancy is a developmental issue. This
can last into adult life.11 Painful neonatal experiences have long term consequences.
Although not expressed as conscious memory, memories of pain may be recorded
biologically and alter brain development and subsequent behavior.12
Self-reporting is the single most reliable indicator of the existence and intensity of
acute pain. Self-reporting is the gold standard of pain assessment. However, neonates
are unable to verbalize pain, thus, further complicating its assessment. 13 Assessing pain
in infants and nonverbal children is a challenge for health professionals. It is difficult to
determine whether the distressed behaviors of the neonate represent pain, fear, hunger,
or a range of other emotions. Assessment of pain is a big challenge because of its
subjective nature.14
The pain assessment tool recommended by the American Academy of Pediatrics
should be multidimensional, including measurements for both physiologic and behavioral
indicators of pain, because neonates cannot self-report pain.15 Physiologic indicators of
pain include changes in heart rate, respiratory rate, blood pressure, oxygen saturation,
vagal tone, palmar sweating, and plasma cortisol or catecholamine concentrations.
Behavioral indicators include changes in facial expressions, body movements, and
crying. 13
The most commonly used assessment tools are listed in Appendix 1. Each tool
was described using the physiologic and behavioral indicators of pain, the age of
gestation of the subjects for which they have been validated, and the nature of pain
assessed.
In this study, the Crying, Requires Oxygen Saturation, Increased Vital Signs,
Expression, Sleeplessness (CRIES) Scale [Appendix 5], Neonatal Infant Pain Scale
(NIPS) [Appendix 6], and Face, Legs, Activity, Cry and Consolability (FLACC) Scale
[Appendix 7] were used to evaluate pain in neonates undergoing heel-prick procedure.
The CRIES scale and NIPS were chosen due to their established validity and reliability

in previous studies done abroad. The FLACC scale is currently being used by the
Department of Anesthesiology of TMC in assessing post-operative pain in pre-verbal
patients and children. The FLACC scale was included in the study to determine its
applicability among neonates exposed to procedural pain.
The CRIES (Crying, Requires Oxygen for Saturation >95%, Increased Vital
Signs, Expression, and Sleeplessness) Scale was developed by Judy Bildner, RNC,
MSN. This pain scale was designed to document a neonates pain response to invasive
procedures. The CRIES scale is a multidimensional scale which uses physiological and
behavioral variables previously shown to be associated with neonatal pain. The
variables evaluated are as follows:

(1) Crying, (2) Requires Oxygen for Saturation

>95%, (3) Increased Vital Signs, (4) Expression, and (5) Sleeplessness. Each variable is
scored 0, 1 or 2. The highest score possible for this scale is 10, indicating severe pain.16
Based on the initial testing of the CRIES scale done by SW. Krechel and J.
Bildner,

the scale was found to be a valid, reliable and well-accepted tool by neonatal

nurses and physicians to assess post-operative pain in neonates 32-60 weeks age of
gestation. Reliability and validity were established by measuring pain after administering
analgesics, with a significant decrease in measured pain observed following treatment.17
The Neonatal Infant Pain Scale (NIPS) is a multidimensional scale used in full
term and pre-term infants. The assessment scale is a neonatal adaptation of the
Childrens Hospital of Eastern Ontario Pain Scale (CHEOPS). Five behaviors are
evaluated, namely: (1) facial expression, (2) cry, (3) arm, (4) legs, (5) state of arousal.
Each behavioral variable is scored 0 or 1 except cry which is scored 0, 1 or 2. One
physiological indicator, the breathing pattern, is evaluated also. The total score range
from 0-7. 18
Suraseranivongse et al recommend the NIPS as a valid, reliable and practical
tool. In the study, the NIPS was used to evaluate post-operative pain in 22 neonates.
The scale had excellent interrater reliability (intraclass correlation >0.9), high sensitivity
and specificity (>90%), and in terms of practicality, it was the most acceptable (65%). 19
The Face, Legs, Activity, Cry, and Consolability (FLACC) pain scale is an interval
scale that measures pain by quantifying pain behaviors. Five (5) categories of behavior
are included in the scale: facial expression, leg movement, activity, cry, and
consolability. Total score range from 0-10. The 0-10 score has been interpreted in terms

of absence of pain (0), mild pain (1-3), moderate pain (4-6), and severe pain (7-10).20
Research in a post-anesthesia unit, done by Merkel et al, showed that the
FLACC scale is a valid and reliable tool that was easy to use in patients 2 months to 7
years of age. Manworren and Hynan affirmed the evidence of the validity, reliability, and
clinical utility of the FLACC Pain Assessment Tool for assessing surgical pain intensity in
preverbal children.

In this study, pain in 147 children under 3 years of age was

assessed using the FLACC scale. Pre-analgesia FLACC scores were significantly higher
than post-analgesic scores.20
To give optimal pain management, there is a need for competent pain
assessment, which is especially difficult to perform in neonates.15 'The cornerstone to
adequate pain treatment in this population is the availability of adequate pain
assessment methods.'14 The Policy Statement of the American Academy of Pediatrics
on the Prevention and Management of Pain and Stress in the Neonate states that there
is a need for development and validation of neonatal pain assessment tools that are
easily applicable in the clinical setting.4 'The availability of adequate assessment tools is
critical for reducing the under treatment of neonatal pain'. 14
Every health care facility caring for neonates should implement an effective pain
prevention program which includes strategies for routinely assessing pain. Currently, no
studies are found in the local setting comparing available neonatal pain assessment
tools despite the growing number of research world-wide focused on refining these tools.
Validity and reliability are important characteristics of a pain assessment tool. However,
a tool that is highly valid and reliable in measuring pain may be too cumbersome to use
in the clinical setting. Therefore, when selecting a pain assessment tool, the clinical
utility or feasibility relative to the setting should be taken into consideration. This would
ensure compliance among health professionals and success in the implementation of a
standardized pain assessment and management.
Pain assessment in neonates is complex. There are innumerable challenges but
the opportunity to maximize the comfort and health of the neonate is great.

III. OBJECTIVES
General Objectives:
To evaluate the three pain assessment scales: (1) Neonatal Infant Pain Scale (NIPS),
(2)

Crying,

Requires

Oxygen

Saturation,

Increased

Vital

Signs,

Expression,

Sleeplessness (CRIES) Scale and Face, Legs, Activity, Cry and Consolability (FLACC)
Scale on neonates at The Medical City Neonatal Intensive Care Unit (TMC-NICU)
undergoing heel-prick procedures from July-September 2007
Specific Objectives:
1. To determine the inter-observer reliability of the three pain scales among NICU
residents, nurses and midwives
2. To determine the feasibility of the three pain scales among NICU residents,
nurses and midwives

IV. MATERIALS AND METHODS

A. Patient Participants (Neonates)
After the approval of the research project by the Research Ethics
Committee of The Medical City, this prospective study included neonates
according to the following inclusion and exclusion criteria:
1. Inclusion Criteria
Included in the study were newborn infants with written consent from the
parent; gestational age 37-40 weeks; postnatal age between 24-72 hours of
life; clinically stable from a respiratory, hemodynamic and metabolic point of
view; have not received acute painful stimuli for at least 30 minutes prior to the
experimental observation. An interval of 30-60 minutes was allowed to elapse
between the last feeding and the start of the evaluation. The subjects were calm
and responsive.
2. Exclusion Criteria
The following newborns are excluded from the population to be analyzed:
newborns to whom muscle relaxants, analgesics, and/or sedatives had been
administered; intubated neonates.

B. Identification of Neonates
The subjects were identified and the following neonatal data were
registered: type of delivery, birth weight in grams, gestational age in weeks,
gender, APGAR score at one and five minutes, and postnatal age.
C. NICU Staff Participants (Subjects)
The participants consisted of four (4) NICU residents, eight (8) nurses
and six (6) midwives currently employed full time at The Medical City-NICU for
more than six (6) months. The study participants volunteered to attend the Pain
Scale Training Seminar.

D. Pain Scales
The three (3) pain scales were used with the following parameters:
1. CRIES Scale is defined by the following variables: (1) crying, (2)
requires Oxygen for saturation >95%, (3) increased vital signs, (4)
expression, and (5) sleeplessness. Each variable is scored 0, 1 or 2. The
highest score possible for this scale is 10
2. Neonatal Infant Pain Scale is defined by the following variables:(1)
facial expression, (2) cry, (3) breathing pattern, (4) arms, (5) legs, (6)
state of arousal. Each variable is scored 0 or 1, except cry which is
scored 0,1 or 2. The highest possible score for this scale is 7.
3. FLACC Scale is defined by the following variables: (1) facial
expression, (2) leg movement, (3) activity, (4) cry, and (5) consolability.
Each variable is scored 0,1 or 2. The highest score possible for this scale
is 10.
E. Videotaping
Consents were obtained from parents of the eight subjects to be recorded
on video. The videotaping of the procedure started after each subject was placed
under a radiant warmer, unswaddled and hooked to a pulse oximeter at the left
foot. The video focused on the subjects face and body. Sound was included with
the video to assess crying. The video recording was discontinued five (5) minutes
after the completion of the procedure.

F. Pain Scale Training Seminar

Six (6) residents, eight (8) neonatal nurses and (4) midwives from the
Neonatal Intensive Care Unit of The Medical City, participated in the Pain Scale
Training Seminar. The training seminar included patient identification, discussion
of the categories of the three pain scales (CRIES, NIPS and FLACC), description
of the specific behavioral and physiologic variables in each scale, scoring, and
data collection form completion. The training took 45 minutes.
Each participant independently assigned a score to the videotaped
subjects. The scores were then compared among the participants to determine
inter-observer agreement.
At the end of the seminar, each participant completed a questionnaire
[Appendix 8] ranking the three pain scales according to ease-of-use, identifying
which pain scale was the easiest to understand and which would be most useful
at the NICU. All comments regarding the content of the pain scales were also
documented.
G. Bedside Observation
Consents were obtained from parents of 30 neonates who underwent the
heel-prick procedure for the routine Newborn Screening Test. Each subject was
placed under a radiant warmer, unswaddled and hooked to a pulse oximeter at
the left foot. Heel prick was done by a 1st Year Pediatric Resident in a
standardized manner. (The heel was wiped with cotton soaked in alcohol, pricked
with a lancet and squeezed to collect the required amount of blood. A cotton wool
ball was applied to prevent further bleeding.) Two 2nd Year Pediatric Residents
evaluated the neonates at bedside for five (5) minutes using the three pain
scales (CRIES, NIPS, FLACC). During this period the two doctors independently
gave scores to the three pain scales. The doctors were not allowed to talk with
each other or compare scores. The scoring of scales was done in the same
order: 1st - CRIES, 2nd NIPS, 3rd FLACC.

No pain relief attempts were

performed during the observation period.

H. Data Analysis
In Phase I of the study, data were encoded and tallied in SPSS version
10 for windows. Descriptive statistics were generated for all variables. For
nominal data, frequency and percentage were generated. Comparison of the
different variables under study was done using ANOVA. This is used to compare
more than two groups with numerical data (compares means).
In Phase II of the study, the agreement of all pain scales was analyzed
using the Kappa (K) statistic. Values of K were interpreted as follows: <0.2, poor
agreement; 0.21-0.4, fair agreement; 0.41-0.6, moderate agreement; 0.61-0.8,
good agreement; and 0.81-1.0, very good agreement.

10

V. RESULTS
PHASE I
In Phase I of the study, all three pain scales showed agreement among
observers. The results showed, based from the comparison of the mean scores of
observers, that there was no significant difference noted as proven by all p values >0.05.
Table 1. Observer Agreement on CRIES score
CRIES
(Subjects)

Resident (n= 6)
Mean SD

Nurses (n= 8)
Mean SD

Midwife (n= 4)
Mean SD

P value

6.00 1.78

7.18 2.01

7.67 0.58

0.35 (NS)

6.50 1.70

7.12 2.01

7.50 0.50

0.69 (NS)

5.42 2.15

5.81 1.53

7.00 2.18

0.50 (NS)

6.50 2.09

7.44 0.82

7.16 1.04

0.49 (NS)

5.25 2.32

6.06 1.05

5.33 0.76

0.60 (NS)

4.58 2.04

4.06 1.70

3.83 2.02

0.82 (NS)

5.33 2.42

4.94 1.59

6.16 0.76

0.62 (NS)

6.42 2.99

7.00 1.60

5.17 1.53

0.48 (NS)

Cries Over-all

5.75 1.80

6.20 1.12

6.23 0.69

0.80 (NS)

Table 1 shows the agreement among observers on CRIES score. The results
showed, based from the comparison of the mean scores of observers, that there was no
significant difference noted as proven by all p values >0.05. This means that all three
observers were comparable in their observation of CRIES. Both individual CRIES and
over-all scores for CRIES were not significantly different (p>0.05).

Table 2. Observer Agreement on NIPS score

NIPS
1
2
3
4
5
6
7
8
Nips Over-all

Resident (n= 6)
Mean SD
6.50 1.22
6.25 1.36
4.83 1.63
6.42 1.20
4.83 1.75
4.00 2.04
4.75 2.09
5.92 1.63
5.44 1.06

Nurses (n= 8)
Mean SD
6.31 0.59
5.18 1.39
5.25 1.56
6.38 0.92
5.88 1.33
2.62 1.38
4.19 0.75
6.75 0.71
5.32 0.68

Midwife (n= 4)
Mean SD
6.83 0.29
5.66 0.58
4.00 1.50
6.33 0.58
5.33 0.76
2.67 1.52
3.67 0.76
6.50 0.50
5.12 0.50

P value
0.66 (NS)
0.34 (NS)
0.52 (NS)
0.99 (NS)
0.42 (NS)
0.30 (NS)
0.54 (NS)
0.40 (NS)
0.86 (NS)

Table 2 shows the agreement among observers on NIPS score. The results showed,
based from the comparison of the mean scores of observers, that there was no
significant difference noted as proven by all p values >0.05. This means that all three

11

observers were comparable in their observation of NIPS. Both individual NIPS and overall scores for NIPS were not significantly different (p>0.05).

Table 3. Observer Agreement on FLACC score

FLACC

Resident (n= 6)
Mean SD

Nurses (n= 8)
Mean SD

Midwife (n= 4)
Mean SD

P value

7.75 2.32

7.94 1.12

8.33 1.15

0.88 (NS)

7.75 1.37

6.81 2.37

5.83 0.58

0.36 (NS)

5.17 1.75

6.31 1.89

5.67 0.58

0.48 (NS)

8.92 2.20

8.69 1.22

8.33 1.53

0.89 (NS)

5.50 3.12

7.50 1.83

6.67 7.76

0.31 (NS)

4.42 3.10

4.19 1.77

4.00 1.50

0.96 (NS)

4.67 3.14

5.63 1.16

5.83 1.04

0.63 (NS)

7.08 2.44

8.56 1.12

8.00 1.80

0.34 (NS)

FLACC Over-all

6.40 1.72

6.95 1.23

6.58 0.96

0.76 (NS)

Table 3 shows the agreement among observers on FLACC score. The results
showed, based from the comparison of the mean scores of observers, that there was no
significant difference noted as proven by all p values >0.05. This means that all three
observers were comparable in their observation of FLACC. Both individual FLACC and
over-all scores for FLACC were not significantly different (p>0.05).

Table 4. Ease of Use of each (n=18)

Very easy to use

Fairly easy
Difficult
Easiest
understand
Most Useful

to

CRIES
0
0
18 (100%)

NIPS
16 (88.9%)
2 (11.1%)
0

FLACC
2 (11.1%)
15 (88.9%)
0

16 (88.9%)

2 (11.1%)

16 (88.9%)

2 (11.1%)

The NIPS was selected by 16 participants (88.9%) as the easiest-to-use tool for
pain assessment followed by the FLACC Scale (11.1%), chosen by 2 participants in the
Pain Scale Training Seminar. The NIPS was also chosen as the easiest to understand
and deemed most useful at the NICU (88.9%) by the residents, nurses and midwives.
The CRIES Scale was unanimously chosen as the most difficult pain scale to
understand and implement at the NICU.

12

PHASE II

Table 5. Comparison of the Scoring on CRIES, NIPS and FLACC

Kappa

Interpretation

CRIES

0.441

Moderate agreement

NIPS

0.469

Moderate agreement

FLACC

0.221

Fair agreement

Comparing the agreement of pain scales, the CRIES scale and NIPS showed
Kappa values of 0.441 and 0.467, respectively, interpreted as moderate agreement. The
FLACC scale showed fair agreement with a Kappa of 0.221.
Table 6. Scoring on CRIES
CRIES1
Score of 8
Score of 9
Score of 10
Total

CRIES 2
Score of 7
2
2
0
4

Score of 8
2
4
0
6

Total

Score of 9
1
9
3
13

Score of 10
0
3
4
7

5
18
7
30

Agreement = 50%
Disagreement = 50%
Table 7. Scoring on NIPS
NIPS1
Score of 5
Score of 5
Score of 6
Score of 7
Total

0
2
0
2

NIPS 2
Score of 6
1
8
3
12

Total
Score of 7
0
5
11
16

1
15
14
30

Agreement = 63.3%
Disagreement = 36.7%
Table 8. Scoring on FLACC
FLACC1

FLACC 2

Total

13
Score of 8

Score of 9

Score of 10

Score of 8
Score of 9
Score of 10
Total

1
1
0
2

3
7
8
18

1
5
4
10

5
13
12
30

Agreement = 40.0%
Disagreement = 60.0%
Tables 6, 7 and 8 show the rate of agreement of the score given by 2 observers.
The NIPS had the highest rate of agreement at 63.3% while the FLACC scale showed
40% rate of agreement.

VI. DISCUSSION
The study had two phases: Pain Scale Training Seminar (Phase I) and Bedside
Observation (Phase II). The Pain Scale Training Seminar was participated by the
Neonatal Intensive Care Unit Staff composed of six (6) Resident Pediatricians, eight (8)
Neonatal Nurses, and four (4) Midwives. The participants viewed eight (8) neonatal
subjects undergoing heel-prick on video and assessed the intensity of acute pain using
the three (3) pain scales: CRIES scale, NIPS and FLACC scale.
The participants were grouped according to their medical background. The
scores given by the residents, nurses and midwives were comparable indicating that
standard education enables the NICU staff to use the pain scales. In addition, the scores
assessed by the pain scales were consistent.
However, the video provided the participants with only an audiovisual depiction of
the subjects pain experience. The video format denied them use of palpation to assess
the subjects muscle tone. The participants were also unable to console the video
subjects. These factors definitely affected the accuracy of pain assessment, usually
underestimating the degree of pain. Despite the limitation of assessing videotaped
subjects, the scores given by the different observers were comparable.
The participants of the seminar were also asked to evaluate the pain scales after
applying them on the videotaped subjects. The Neonatal Infant Pain Scale was chosen
as the tool easiest to use and understand. It was deemed most useful in the NICU
setting. The participants preferred the NIPS.
On the other hand, the CRIES scale failed in this aspect. The participants took
more time to understand the variables and answer the pain scale. It was noted that the
preparations needed to use the CRIES scale was time-consuming and taxing. The14

participants specified the use of the pulse oximeter and the monitoring of blood pressure
as obstacles in the completion of the pain assessment. In order to hook and secure the
two equipment (blood pressure cuff and pulse oximeter probe), physical manipulations of
the neonates extremities are needed. This would subject the neonate to undue stress
and cause inaccuracies in the determination of physiologic variables such as oxygen
saturation, heart rate and blood pressure. Based on their observations, even if the pulse
oximeter probe was secured properly, the slightest movement of extremities caused
fluctuations in the readings of the heart rate and pulse oximeter, more so, with the

introduction of the painful stimulus (heel prick). Another participant also commented that
difficulty in the completion of the assessment was due to the need to calculate the
percent (%) change in the heart rate and blood pressure. All the participants identified
the CRIES scale as impractical in the actual setting. Taking into account the limited
number of resources (equipment and manpower) and the increasing number of
admissions at the NICU, the successful implementation of the CRIES scale is highly
improbable.
The Neonatal Infant Pain Scale is the tool-of-choice of the NICU staff. In an open
forum, the staff is amenable in implementing the pain scale. Pain, being the fifth vital
sign, should be included in the routine monitoring of neonates at the NICU. An easy-touse tool such as this will encourage compliance among NICU staff. This would facilitate
consistency in pain assessment which is the building block of a successful pain
management program.
In Phase II of the study, NIPS had the best rate of agreement at 63.3% as
compared to the CRIES and FLACC scale with 50% and 40%, respectively. The NIPS
and CRIES scale scores given by two residents who observed the neonates at bedside
showed moderate agreement with a Kappa of 0.469 and 0.441 respectively. Scores
using the FLACC scale showed only fair agreement with a Kappa of 0.221.
Various research and information on neonatal pain are available but it is not
universally applied. The causes may be due to the additional work load it imposes on the
neonatal staff, misconceptions on the topic of neonatal pain, and fear from deviating
from the status quo. This is the reason why continuous education on pain assessment
and management should be advocated.
The Medical City is in need of standardizing a pain assessment tool for the15

NICU.

A valid, reliable and easy-to-use tool is ideal. In this study, the Neonatal Infant

Pain Scale is highly recommended based on its interobserver reliability and feasibility.
However, further studies supporting the validity and reliability of the NIPS involving a
larger group of observer and neonate at TMC-NICU are highly recommended.
Neonatal

pain

assessment

and

management

is

continuous

quality

improvement measure for international health care facilities such as The Medical City.
There is a need to formulate an effective pain assessment and management strategy to
move a notch higher not just for accreditation purposes but in terms of quality patient
care.
VII. CONCLUSION

The three pain scales had comparable inter-observer reliability among residents,
nurses and midwives. Regarding feasibility, the Neonatal Infant Pain Scale was chosen
as the easiest-to-use pain assessment tool at the NICU. Bedside assessment done by
two residents using the NIPS and CRIES scale showed moderate agreement. The NIPS
had the best rate of agreement at 63.3%.

16

BIBLIOGRAPHY
1. Franck LS, Cox S, Allen A, Winter I. Parental Concern and Distress About Infant
Pain. Arch Dis Child Fetal Neonatal Ed 2004; 89:F71-F75
2. PubMed Morelius E, Hellstrom-Westas L, Carlen C, Norman E, Nelson N. Early
Hum Dev. 2006 Oct; 82[10]669-76.EPUB 2006 FEB 28.
3. Joint Commission on the Accreditation of Healthcare Organizations. (2002). Hospital
accreditation standards: Accreditation policies, standards, intent statements.
Oakbook Terrace, IL: Author
4.

American Academy of Pediatrics. Committee on Fetus and Newborn.

and management of pain and stress in the neonate.

5

Prevention

Pediatrics.2000; 105:454-461

W.B. Saunders. A systematic integrative review of infant pain

assessment

tools. Advanced Neonatal Care 4(3): 126-140, 2004.

6 International Association for the Study of Pain. (2001). IASP definition of pain.
International Association for the Study of Pain Newsletter. 2,2.
7 Haouari, N., Woods, C., Griffiths,G., and Levene, M. (1995). The analgesic effect of
sucrose on full term infants: A randomized controlled trial. British Medical Journal,
310 (6993), 1498-1500.
8 Bell SG. The national pain management guideline: Implications for neonatal
intensive care. Neonatal Network 1994; 13: 9-17.
9 Fitzgerald M, Beggs S. The neurobiology of pain: Developmental aspects. The
Neuroscientist 7[3]: 246-257, 2001.
10. Taddio A, Katz J, Ilersich AL, Koren G. Effect of neonatal circumcision on pain17

response during subsequent routine vaccination. Lancet. 1997; 349:599-603

11. Johnston CC, Stevens BJ. Experience in a neonatal intensive care unit affects
pain response. Pediatrics. 1996; 98:925-930
12. Anand KJS and Scalzo FM. Can adverse experiences alter brain development
and subsequent behavior? Biology of the Neonate 2000; 77:69-82.
13. Howard RF. Current status of pain management in children. JAMA 2003; 290:

2464-69.

14. Perreira A, Guinsburg R. Validity of behavioral and physiologic parameters for

acute pain assessment of term newborn infants. Sao Paolo Med J/Rev Paul
Med.1999; 117[2]:72-80.
15. American Academy of Pediatrics. Committee on Fetus and Newborn.

Prevention

and management of pain and stress in the neonate. Pediatrics.2006; 118:2231-2241

16. Bildner, J. CRIES instrument: Assessment: tool of pain in neonates. 1996.
17. Krechel SW, Bildner J. CRIES: A new neonatal postoperative pain measurement
score. Initial setting of validity and reliability. Paediatric Anaesth 1995; 5: 53-61.
18. Lawrence, J., Alcock, D., Mc Grath,P., Kay, J., Mac Murray, SB., Dulberg, C. The
development of a tool to assess neonatal pain. Neonatal Netw 1993; 12: 59-65.
19. Suraseranivongse, S., Kaosaard,R., Intakong, P., Pornsiriprasert, S., Karnchana, Y.,
Kaopinpruck, J., and Sangjeen K. A comparison of postoperative scales in
neonates. Brit Journal of Anaesthesia 97(4): 540-4 (2006).
20. Manworren, R., Hynan, L. Clinical validation of FLACC: Preverbal patient pain
scale. Pediatric Nurs 29 (2): 140-146, 2003.

18

APPENDIX 1
Pain-Assessment Tools

19

Assessment Tool

Physiologic
Indicators

Behavioral
Indicators

Gestational
Age Tested

Assesses
Sedation

Scoring
Adjusts for
Gestational
Age

Nature of Pain
Assessed

PIPP: Premature
Infant Pain Profile

Heart rate,
oxygen
saturation

Brow bulge, eyes

squeezed shut,
nasolabial furrow

2840 wk

No

Yes

Procedural
and
postoperative
pain

CRIES: Crying,
Requires Oxygen
Saturation,
Increased Vital
Signs,
Expression,
Sleeplessness

Heart rate,
oxygen
saturation

Crying, facial
expression,
sleeplessness

3236 wk

No

No

Postoperative
pain

NIPS: Neonatal
Infant Pain Scale

Respiratory
patterns

Facial
expression, cry,
movements of
arms and legs,
state arousal

2838 wk

No

No

Procedural
pain

N-PASS:
Neonatal Pain
Agitation and
Sedation Scale

Heart rate,
respiratory rate,
blood pressure,
oxygen
saturation

Crying, irritability,
behavior state,
extremities tone

0100 d of
age and
adjusts score
on the basis
of gestational
age

Yes

Yes

Ongoing and
acute pain and
sedation

NFCS: Neonatal
Facing Coding
System

None

Facial muscle
group movement

Preterm and
term
neonates,
infants at 4
mo of age

No

No

Procedural
pain

PAT: Pain
Assessment Tool

Respirations,
heart rate,
oxygen
saturation,
blood pressure

Posture, tone,
sleep pattern,
expression, color,
cry

Neonates

No

No

Acute pain

SUN: Scale for

Use in Newborns

Central nervous
system state,
breathing, heart
rate, mean
blood pressure

Movement, tone,
face

Neonates

No

No

Acute pain

EDIN: Echelle de
la Douleur
Inconfort
Nouveau-Ne'
(Neonatal Pain
and Discomfort
Scale)

None

Facial activity,
body movements,
quality of sleep,
quality of contact
with nurses,
consolability

2536 wk
(preterm
infants)

No

No

Prolonged
pain

BPSN: Bernese
Pain Scale for
Neonates

Heart rate,
respiratory rate,
blood pressure,
oxygen
saturation

Facial
expression, body
posture,
movements,
vigilance

Term and
preterm
neonates

No

No

Acute pain

20

APPENDIX 2
CONSENT FORM
(Heel Prick Procedure)

As parent/legal guardian of ___________________________, I fully consent to my

babys participation in the research study entitled A Comparative Study on Two Pain
Assessment Scales for Neonates at The Medical City Neonatal Intensive Care Unit
under the supervision of Dr. Miki Yamamoto-Balin from The Medical City Hospital. The
following are understood before I agreed to sign this consent form:
1. The purpose of the said study is to compare the two neonatal pain scales based on
ease of use, use of peripheral equipment, intra- and interobserver variability to
effectively manage pain in neonates
2. My babys participation in this study will pave the way for the development of pain
reduction strategies that may be applied in the NICU. This would ease the burden of
neonates undergoing painful but routine procedures in the unit.
3. I am informed that my baby will undergo HEEL PRICK PROCEDURE for the
Newborn Screening Test mandated by law. Blood will be extracted by puncturing the
heel using a sterile lancet. A few drops of blood are required to fill in the space in the
filter paper provided. Pressure will be applied over the puncture site to stop the
bleeding.
4. My baby will be filmed using a video camera throughout the procedure.
5. Dr. Miki Yamamoto-Balin will coordinate with us regarding the results of the
study.
6. All the records/data pertaining to my baby will remain confidential.
7. My babys participation in this study is completely voluntary and we may at any
point choose not to complete the study.
8. We can contact Dr. Miki Yamamoto-Balin at telephone number 631-3599,
Department of Pediatrics, The Medical City for any questions we may have regarding
the study.
Name of Parent/Guardian:___________________
Name of Child:____________________________
Address:_________________________________
________________________________________
Signature:________________________________
Date:____________________________________
Witnessed by:
_______________________
_______________________
Signature over Printed Name
Signature over Printed Name

APPENDIX 3

21

PAHINTULOT
(Heel Prick Procedure)

Bilang magulang/tagapangalaga, sumasang-ayon akong lumahok and aking

anak/alaga na si _____________________________ sa pananaliksik na pinamagatang A
Comparative Study on Two Pain Asssessment Scales for Neonates at The Medical City
Neonatal Intensive Care Unit sa pamamahala ni Dr. Miki Yamamoto-Balin ng Medical
City Department of Pediatrics. Ang mga sumusunod ay lubos kong nauunawaan bago ko
nilagdaan and kasulatang ito:
1. Ang layunin ng pananaliksik ay paghambingin ang dalawang sukatan ng
kirot/sakit sa mga sanggol ayon sa dali ng paggamit, pangangailangan ng mga
kasangkapang medical, at katiyakan sa pagtakda ng antas ng sakit.
2. Ang paglahok ng aking anak/alaga ay magbibigay-daan sa pagbuo ng mga paraan
upang maibsan ang sakit na nadarama ng mga sanggol sa mga mahalagan
pagsusuri na ginagawa sa Neonatal Intensive Care Unit (NICU).
3. Alam ko na sasailalim ang aking anak/alaga sa HEEL-PRICK PROCEDURE o
pagtusok sa sakong gamit ang sterile lancet para sa Newborn Screening Test na
naaayon sa batas. Sa pagsusuring ito, ang dugo mula sa sakong ay ipapatak sa
filter paper na isusumite sa National Institute of Health.
4. Kukunan ng video ang aking anak/alaga habang ginagawa ang pagsusuri.
5. Ipaaalam sa amin ni Dr. Miki Yamamoto-Balin ang mga resulta ng pananaliksik.
6. Ang lahat ng tala ukol sa aking anak/alaga ay mananatiling kumpidensyal.
7. Kusang-loob kong isinasali ang aking anak/alaga sa pananaliksik na ito.
Gayunpaman, karapatan ko na bawiin ang paglahok ng aking anak/alaga sa
pananaliksik na ito anumang oras, sa anumang kadahilanan.
8. Para sa anumang katanungan, maaari akong makipag-ugnayan kay Dr. Miki
Yamamoto-Balin sa numerong 631-3599, Department of Pediatrics, The Medical
City.
Pangalan ng Magulang/Tagapangalaga:________________________________________
Pangalan ng Bata:_________________________________________________________
Tirahan:_________________________________________________________________
Lagda:__________________________________________________________________
Petsa:___________________________________________________________________
Saksi:
_________________________
Pangalan at Lagda

_________________________
Pangalan at Lagda

22

APPENDIX 4

PAIN SCALES

Date:__________________________________________
Evaluator:______________________________________
Age/Sex:________________________________________
Position:

3rd Year Resident

2nd Year Resident
1st Year Resident
Intern
Nurse
Midwife

Length of practice at TMC

>5 years
2-5 years
1 year
6-12 months
0-6 months

23

APPENDIX 5

CRIES Pain Scale

Pain Assessment

Score

Score

Crying - Characteristic cry of pain is high pitched.

0

No cry or cry that is not high-pitched

Cry high pitched but baby is easily consolable

Cry high pitched but baby is inconsolable

Requires O2 for SaO2 < 95% - Babies experiencing pain manifest decreased oxygenation.
Consider other causes of hypoxemia, e.g., oversedation, atelectasis, pneumothorax)
0

No oxygen required

< 30% oxygen required

> 30% oxygen required

Increased vital signs (BP* and HR*) - Take BP last as this may awaken child making other
assessments difficult
0

Both HR and BP unchanged or less than baseline

HR or BP increased but increase in < 20% of baseline

HR or BP is increased > 20% over baseline.

Expression - The facial expression most often associated with pain is a grimace. A grimace may
be characterized by brow lowering, eyes squeezed shut, deepening naso-labial furrow, or open
lips and mouth.
0

No grimace present

Grimace alone is present

Grimace and non-cry vocalization grunt is present

Sleepless - Scored based upon the infants state during the hour preceding this recorded score.
0

Child has been continuously asleep

Child has awakened at frequent intervals

Child has been awake constantly

TOTAL

24

APPENDIX 6

Neonatal/Infant Pain Scale (NIPS)

(Recommended for children less than 1 year old) - A score greater than 3
indicates pain
Pain Assessment

Score

Score

Facial Expression
0 Relaxed
muscles
1 Grimace

Restful face, neutral expression

Tight facial muscles; furrowed brow, chin, jaw, (negative
facial expression nose, mouth and brow)

Cry
0 No Cry

Quiet, not crying

1 Whimper

Mild moaning, intermittent

2 Vigorous Cry

Loud scream; rising, shrill, continuous (Note: Silent cry may

be scored if baby is intubated as evidenced by obvious
mouth and facial movement.

Breathing Patterns
0 Relaxed

Usual pattern for this infant

1 Change in
Breathing
Arms

Indrawing, irregular, faster than usual; gagging; breath

holding

0
Relaxed/Restrained
1
Flexed/Extended
Legs

No muscular rigidity; occasional random movements of arms

0
Relaxed/Restrained
1
Flexed/Extended
State of Arousal

No muscular rigidity; occasional random leg movement

0
Sleeping/Awake
1 Fussy

Quiet, peaceful sleeping or alert random leg movement

Tense, straight legs; rigid and/or rapid extension, flexion

Tense, straight legs; rigid and/or rapid extension, flexion

Alert, restless, and thrashing

TOTAL

25

APPENDIX 7

Face Legs Activity Cry Consolability (FLACC)

Pain Assessment

Score

Score

Face
0

No particular expression or smile

Occasional grimace or frown, withdrawn, disinterested

Frequent to constant quivering chin, clenched jaw

Legs
0

Normal position or relaxed

Uneasy, restless, tense

Kicking, or legs drawn up

Activity
0

Lying quietly, normal position moves easily

Squirming, shifting back and forth, tense

Arched, rigid or jerking

Cry
0

No cry, (awake or asleep)

Moans or whimpers; occasional complaint

Crying steadily, screams or sobs, frequent complaints

Consolability
0

Content, relaxed

Reassured by occasional touching hugging or being

talked to, distractable
Difficulty to console or comfort

2
TOTAL

26

APPENDIX 8

1. Rank the three pain scales according to ease-of-use:

(1- very easy to use, 2- fairly easy to use, 3- difficult to use)
_________CRIES
_________NIPS
_________FLACC

2. Which pain scale is easiest to understand? Check your choice:

_________CRIES
_________NIPS
_________FLACC

3. Which pain scale would be most helpful at the NICU?

_________CRIES
_________NIPS
_________FLACC

APPENDIX 9

27

Videotaped Babies

Baby
1
2
3
4
5
6
7
8

Sex
M
M
M
M
F
F
F
F

BW
3525
3505
3645
3285
2605
3230
2510
2645

Del
NSD
CS
CS
NSD
CS
NSD
CS
CS

AOG
39
38
39
39
38
39
37
39

DOB
9/18
9/18
9/17
9/18
9/18
9/22
9/18
9/21

DOC
9/20
9/20
9/20
9/20
9/20
9/23
9/20
9/23

Age (HR)
48
48
72
48
48
24
48
48

DOC
9/30
9/30
9/30
9/30
9/30
9/30
9/30
9/30
9/30
9/30
9/30
9/30
9/30
9/30
9/30
9/30
9/30
9/29
9/29
9/29
9/29
9/29
9/29
9/29
9/29
9/29
9/28
9/28
9/28
9/28

Age (HR)
48
24
24
48
48
48
72
72
72
24
48
24
48
72
24
48
72
48
24
48
48
48
48
48
72
48
48
48
48
72

Observed Babies

Baby
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30

Sex
M
F
M
F
F
M
M
M
F
F
F
F
F
M
F
M
F
M
F
F
F
F
M
M
M
M
F
F
M
F

BW
3265
2535
3940
2950
3220
3565
2755
3165
3300
3350
2835
3010
2980
2925
3205
3145
2305
2835
3280
2725
3020
2455
4180
3210
2915
3105
2980
2780
3485
2595

Del
NSD
NSD
CS
CS
NSD
NSD
CS
CS
NSD
NSD
NSD
NSD
NSD
CS
NSD
CS
CS
NSD
CS
NSD
CS
NSD
CS
CS
CS
NSD
CS
NSD
CS
NSD

AOG
38
40
39
39
38
40
38
39
39
39
38
39
38
37
40
38
37
38
39
40
40
37
40
39
38
41
38
40
38
40

DOB
9/28
9/29
9/29
9/28
9/28
9/28
9/27
9/27
9/27
9/29
9/28
9/29
9/28
9/27
9/29
9/28
9/27
9/27
9/28
9/27
9/27
9/27
9/27
9/27
9/26
9/27
9/26
9/26
9/26
9/25

28

APPENDIX 10
CRIES

NIPS

FLACC

OBS

BB1

10

BB2

BB3

10

BB4

10

BB5

BB6

BB7

BB8

BB9

BB10

10

BB11

10

BB12

10

10

BB13

10

10

10

10

BB14

10

10

BB15

10

10

BB16

10

10

BB17

10

BB18

BB19

BB20

10

BB21

10

10

BB22

10

10

10

10

BB23

10

10

10

BB24

10

10

10

BB25

10

10

BB26

10

10

BB27

10

BB28

BB29

BB30

18 OBSERVERS

CRIES

NIPS

FLACC

VERY EASY TO USE

16

FAIRLY EASY

16

DIFFICULT

17

16

16

EASIEST TO UNDERSTAND
MOST USEFUL

29

30