Evaluation of Three Pain Assessment Scales for Neonates at the Medical City Neonatal Intensive Care Unit

8/9/2019 Evaluation of Three Pain Assessment Scales for Neonates at the Medical City Neonatal Intensive Care Unit

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EVALUATION OF THREE PAIN ASSESSMENT SCALES FORNEONATES AT THE MEDICAL CITY

NEONATAL INTENSIVE CARE UNIT

Miki Yamamoto-BalinThe Medical City

Pasig City, Philippines

Objective: The study aims to assess the inter-observer reliability and feasibilityof 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 TheMedical City – Neonatal Intensive Care Unit participated a Pain Scale TrainingSeminar. Videos of 8 neonates undergoing the heel-prick procedure wereassessed 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 nosignificant difference noted as proven by all p values >0.05. As compared to theCRIES Scale and FLACC Scale, the Neonatal Infant Pain Scale was chosen asthe 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 observedthe neonates at bedside showed moderate agreement with a Kappa of 0.469 and0.441 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 tothe CRIES and FLACC scale with 50% and 40%, respectively.

Conclusion: The 3 pain scales had comparable inter-observer reliability amongresidents, nurses and midwives. Regarding feasibility, the Neonatal Infant PainScale was assessed as the easiest-to-use pain assessment tool at the NICU.Bedside assessment done by 2 residents using the NIPS and CRIES scaleshowed moderate agreement. The NIPS had the best rate of agreement at63.3%.


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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 heel-

prick, 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.


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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


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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


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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 neonate’s 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

Children’s 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


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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.


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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 Part ic ipants (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.


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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 Partic ipants (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 subject’s 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.


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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.


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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:


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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

1 6.00 ± 1.78 7.18 ± 2.01 7.67 ± 0.58 0.35 (NS)

2 6.50 ± 1.70 7.12 ± 2.01 7.50 ± 0.50 0.69 (NS)

3 5.42 ± 2.15 5.81 ± 1.53 7.00 ± 2.18 0.50 (NS)

4 6.50 ± 2.09 7.44 ± 0.82 7.16 ± 1.04 0.49 (NS)

5 5.25 ± 2.32 6.06 ± 1.05 5.33 ± 0.76 0.60 (NS)

6 4.58 ± 2.04 4.06 ± 1.70 3.83 ± 2.02 0.82 (NS)

7 5.33 ± 2.42 4.94 ± 1.59 6.16 ± 0.76 0.62 (NS)

8 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 Resident (n= 6)Mean ± SD

Nurses (n= 8)Mean ± SD

Midwife (n= 4)Mean ± SD

P value

1 6.50 ± 1.22 6.31 ± 0.59 6.83 ± 0.29 0.66 (NS)

2 6.25 ± 1.36 5.18 ± 1.39 5.66 ± 0.58 0.34 (NS)

3 4.83 ± 1.63 5.25 ± 1.56 4.00 ± 1.50 0.52 (NS)

4 6.42 ± 1.20 6.38 ± 0.92 6.33 ± 0.58 0.99 (NS)

5 4.83 ± 1.75 5.88 ± 1.33 5.33 ± 0.76 0.42 (NS)

6 4.00 ± 2.04 2.62 ± 1.38 2.67 ± 1.52 0.30 (NS)

7 4.75 ± 2.09 4.19 ± 0.75 3.67 ± 0.76 0.54 (NS)

8 5.92 ± 1.63 6.75 ± 0.71 6.50 ± 0.50 0.40 (NS)

Nips Over-all 5.44 ± 1.06 5.32 ± 0.68 5.12 ± 0.50 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



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observers were comparable in their observation of NIPS. Both individual NIPS and over-

all 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

1 7.75 ± 2.32 7.94 ± 1.12 8.33 ± 1.15 0.88 (NS)

2 7.75 ± 1.37 6.81 ± 2.37 5.83 ± 0.58 0.36 (NS)

3 5.17 ± 1.75 6.31 ± 1.89 5.67 ± 0.58 0.48 (NS)

4 8.92 ± 2.20 8.69 ± 1.22 8.33 ± 1.53 0.89 (NS)

5 5.50 ± 3.12 7.50 ± 1.83 6.67 ± 7.76 0.31 (NS)

6 4.42 ± 3.10 4.19 ± 1.77 4.00 ± 1.50 0.96 (NS)7 4.67 ± 3.14 5.63 ± 1.16 5.83 ± 1.04 0.63 (NS)

8 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


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)

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.

CRIES NIPS FLACC

Very easy to use 0 16 (88.9%) 2 (11.1%)

Fairly easy 0 2 (11.1%) 15 (88.9%)

Difficult 18 (100%) 0 0

Easiest tounderstand

0 16 (88.9%) 2 (11.1%)

Most Useful 0 16 (88.9%) 2 (11.1%)


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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

CRIES 2CRIES1

Score of 7 Score of 8 Score of 9 Score of 10

Total

Score of 8 2 2 1 0 5

Score of 9 2 4 9 3 18

Score of 10 0 0 3 4 7

Total 4 6 13 7 30

Agreement = 50%

Disagreement = 50%

Table 7. Scor ing on NIPS

NIPS 2NIPS1

Score of 5 Score of 6 Score of 7

Total

Score of 5 0 1 0 1

Score of 6 2 8 5 15

Score of 7 0 3 11 14

Total 2 12 16 30

Agreement = 63.3%

Disagreement = 36.7%

Table 8. Scoring on FLACC

FLACC 2FLACC1

Score of 8 Score of 9 Score of 10

Total


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Score of 8 1 3 1 5

Score of 9 1 7 5 13

Score of 10 0 8 4 12

Total 2 18 10 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. The


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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-to-

use 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 the


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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 a 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%.


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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 child ren. 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 postoperat ive 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.


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APPENDIX 1

Pain-Assessment Tools


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Assessment ToolPhysiologicIndicators

BehavioralIndicators

Gestational Age Tested

AssessesSedation

Scoring Adjusts for

Gestational Age

Nature of Pain Assessed

PIPP: PrematureInfant Pain Profile

Heart rate,oxygen

saturation

Brow bulge, eyessqueezed shut,

nasolabial furrow

28–40 wk No Yes Proceduraland

postoperativepain

CRIES: Crying,Requires OxygenSaturation,

Increased VitalSigns,Expression,

Sleeplessness

Heart rate,oxygensaturation

Crying, facialexpression,sleeplessness

32–36 wk No No Postoperati vepain

NIPS: NeonatalInfant Pain Scale

Respiratorypatterns

Facialexpression, cry,

movements ofarms and legs,

state arousal

28–38 wk No No Proceduralpain

N-PASS:Neonatal Pain

Agitation andSedation Scale

Heart rate,respiratory rate,

blood pressure,oxygensaturation

Crying, irritability,behavior state,

extremities tone

0–100 d ofage and

adjusts scoreon the basisof gestational

age

Yes Yes Ongoing andacute pain and

sedation

NFCS: Neonatal

Facing CodingSystem

None Facial muscle

group movement

Preterm and

termneonates,infants at 4

mo of age

No No Procedural

pain

PAT: Pain

Assessment Tool

Respirations,

heart rate,

oxygensaturation,

blood pressure

Posture, tone,

sleep pattern,

expression, color,cry

Neonates No No Acute pain

SUN: Scale forUse in Newborns

Central nervoussystem state,

breathing, heartrate, meanblood pressure

Movement, tone,face

Neonates No No Acute pain

EDIN: Echelle dela Douleur

InconfortNouveau-Ne'(Neonatal Pain

and DiscomfortScale)

None Facial activity,body movements,

quality of sleep,quality of contactwith nurses,

consolability

25–36 wk(preterm

infants)

No No Prolongedpain

BPSN: BernesePain Scale forNeonates

Heart rate,respiratory rate,blood pressure,

oxygensaturation

Facialexpression, bodyposture,

movements,vigilance

Term andpretermneonates

No No Acute pain


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APPENDIX 2

CONSENT FORM(Heel Prick Procedure)

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

baby’s participation in the research study entitled “A Comparative Study on Two PainAssessment Scales for Neonates at The Medical City Neonatal Intensive Care Unit”under the supervision of Dr. Miki Yamamoto-Balin from The Medical City Hospital. Thefollowing 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 toeffectively manage pain in neonates

2. My baby’s 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 theheel 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 baby’s 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 regardingthe study.

Name of Parent/Guardian:___________________ Name of Child:____________________________Address:_________________________________

________________________________________Signature:________________________________

Date:____________________________________Witnessed by:

_______________________ _______________________Signature over Printed Name Signature over Printed Name

APPENDIX 3


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PAHINTULOT(Heel Prick Procedure)

Bilang magulang/tagapangalaga, sumasang-ayon akong lumahok and akinganak/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 konilagdaan and kasulatang ito:

1. Ang layunin ng pananaliksik ay paghambingin ang dalawang sukatan ngkirot/sakit sa mga sanggol ayon sa dali ng paggamit, pangangailangan ng mgakasangkapang medical, at katiyakan sa pagtakda ng antas ng sakit.

2. Ang paglahok ng aking anak/alaga ay magbibigay-daan sa pagbuo ng mga paraanupang 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 nanaaayon 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. MikiYamamoto-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


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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


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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

1 Cry high pitched but baby is easily consolable

2 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

1 < 30% oxygen required

2 > 30% oxygen required

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

0 Both HR and BP unchanged or less than baseline

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

2 HR or BP is increased > 20% over baseline.

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

0 No grimace present

1 Grimace alone is present

2 Grimace and non-cry vocalization grunt is present

Sleepless - Scored based upon the infant’s state during the hour preceding this recorded score.

0 Child has been continuously asleep

1 Child has awakened at frequent intervals

2 Child has been awake constantly

TOTAL


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APPENDIX 6

Neonatal/Infant Pain Scale (NIPS)

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


Facial Expression

0 – Relaxedmuscles

Restful face, neutral expression

1 – Grimace 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 maybe scored if baby is intubated as evidenced by obviousmouth and facial movement.

Breathing Patterns

0 – Relaxed Usual pattern for this infant

1 – Change inBreathing

Indrawing, irregular, faster than usual; gagging; breathholding

Arms

0 –Relaxed/Restrained

No muscular rigidity; occasional random movements of arms

1 –Flexed/Extended

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

Legs

0 –Relaxed/Restrained

No muscular rigidity; occasional random leg movement

1 –Flexed/Extended

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

State of Arousal

0 –Sleeping/Awake

Quiet, peaceful sleeping or alert random leg movement

1 – Fussy Alert, restless, and thrashing

TOTAL


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APPENDIX 7

Face Legs Act ivity Cry Consolability (FLACC)


Face

0 No particular expression or smile

1 Occasional grimace or frown, withdrawn, disinterested

2 Frequent to constant quivering chin, clenched jaw

Legs

0 Normal position or relaxed

1 Uneasy, restless, tense

2 Kicking, or legs drawn up

Act iv ity

0 Lying quietly, normal position moves easily

1 Squirming, shifting back and forth, tense

2 Arched, rigid or jerking

Cry

0 No cry, (awake or asleep)

1 Moans or whimpers; occasional complaint

2 Crying steadily, screams or sobs, frequent complaints

Consolability

0 Content, relaxed

1 Reassured by occasional touching hugging or beingtalked to, distractable

2 Difficulty to console or comfort

TOTAL


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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


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Videotaped Babies

Baby Sex BW Del AOG DOB DOC Age (HR)

1 M 3525 NSD 39 9/18 9/20 48

2 M 3505 CS 38 9/18 9/20 483 M 3645 CS 39 9/17 9/20 72

4 M 3285 NSD 39 9/18 9/20 48

5 F 2605 CS 38 9/18 9/20 48

6 F 3230 NSD 39 9/22 9/23 24

7 F 2510 CS 37 9/18 9/20 48

8 F 2645 CS 39 9/21 9/23 48

Observed Babies

Baby Sex BW Del AOG DOB DOC Age (HR)

1 M 3265 NSD 38 9/28 9/30 48

2 F 2535 NSD 40 9/29 9/30 24

3 M 3940 CS 39 9/29 9/30 24

4 F 2950 CS 39 9/28 9/30 48

5 F 3220 NSD 38 9/28 9/30 48

6 M 3565 NSD 40 9/28 9/30 48

7 M 2755 CS 38 9/27 9/30 72

8 M 3165 CS 39 9/27 9/30 72

9 F 3300 NSD 39 9/27 9/30 72

10 F 3350 NSD 39 9/29 9/30 24

11 F 2835 NSD 38 9/28 9/30 48

12 F 3010 NSD 39 9/29 9/30 24

13 F 2980 NSD 38 9/28 9/30 48

14 M 2925 CS 37 9/27 9/30 72

15 F 3205 NSD 40 9/29 9/30 24

16 M 3145 CS 38 9/28 9/30 48

17 F 2305 CS 37 9/27 9/30 72

18 M 2835 NSD 38 9/27 9/29 48

19 F 3280 CS 39 9/28 9/29 24

20 F 2725 NSD 40 9/27 9/29 48

21 F 3020 CS 40 9/27 9/29 48

22 F 2455 NSD 37 9/27 9/29 48

23 M 4180 CS 40 9/27 9/29 48

24 M 3210 CS 39 9/27 9/29 48

25 M 2915 CS 38 9/26 9/29 72

26 M 3105 NSD 41 9/27 9/29 48

27 F 2980 CS 38 9/26 9/28 48

28 F 2780 NSD 40 9/26 9/28 48

29 M 3485 CS 38 9/26 9/28 48

30 F 2595 NSD 40 9/25 9/28 72


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Evaluation of Three Pain Assessment Scales for Neonates at the Medical City Neonatal Intensive Care Unit

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