Analgesic Effect of Breast Milk

Versus Sucrose for Analgesia

During Heel Lance in Late Preterm
Infants
Eva Simonse, Paul G. H. Mulder and Ron H. T. van Beek
Pediatrics 2012

SUPERVISOR :
dr. Yulidar Hafidh, SpA(K)
dr. Dwi Hidayah, SpA, MKes

Presented by :
Argadia Yuniriyadi.
Original Article…
Backgrounds

Pain on infant
– Invasive Medical
Procedure
– Other discomfort
condition reaction
- Behavior (crying)
- Physical (tachycardia, >stomach acid, etc)
 Backgrounds
PAIN IN INFANT
• Ethical
• Repeated Pain Stimulus
– Long term child pain
responds dysfunction
(hypersensitive, over reaction)

(Mancuso et al, 2009; Fitzgerald, 2001; Grunau et al, 2006)

Need :

PAIN MANAGEMENT
Background

Skin to skin Pacifier

PAIN MANAGEMENT
Sucrose
Breastfeeding Drugs
(sweet oral)
Breast Milk Vs Sucrose
• Both are the sweet oral liquid
• Breast is more naturally
• Sucrose
– Evidence proven analgesic effect on infant
– (Harrison 2011)  Sucrose
• Less effective when used for prolonged and/or more
intensely painful procedures.
• poorer neurologic outcomes compared with infants who
received fewer sucrose doses

BREAST MILK
• Breastfeeding or Bottled
Background
Premature Infant
• >> more invasive medical procedural needs
• Important risk infant group

Comparing the analgesic effect

Breastfeeding VS Sucrose on preterm
infant
.. .. .. Method
Study Design Randomized Controlled Trial

Time January 2010 to May 2011

Amphia Hospital, Breda,

Place Netherlands.

Assessed for eligibility

Inclusion & Exclusion

Criteria

Patient Randomly Assigned

Supplemental
Breastfeeding Sucrose
Breast Milk
 Subject
Assessed for eligibility

• GA 32+0 and • perinatal asphyxia,

36+6 weeks, birth trauma,
• were being • Cardiorespiratory
nourished with instability,

Exclusion
breastfeeding,

Inclusion
• Gastroesophageal
• had to have a reflux disease,
clinical blood • drug abuse by the
sample taken mother,
(Diagnose & • Sedative medication
Screening) to mother or child

Patient Randomly Assigned

 Breastfeeding
• Mother’s arm

Supplemental Feed
• Held by a nurse
3 observer
• Breast-milk
• Sterile syringe

Sucrose
• 1-2 ml sucrose 24 %
• 2 minutes before

Monitoring before HL : USING :

- HR an automated
- O2 piercing device
OUTPUT Score
• Premature Infant Pain Profile 3 observer

(PIPP)
Postmenstrual age, behavioral state, heart rate, oxygen
saturation, and 3 facial actions

• COMFORTneo
alertness, calmness, respiratory response or crying, body
movement, facial tension, and muscle tone

Unadjusted score analyses  analysis of variance.

Adjusted score analysis  analysis of covariance
 to adjust the estimated effects for the following co-
variables
OUTCOME
RESULT .. .. ..
 Assessed for eligibility (n = 350)

• Refuse for participate (n=20)

• Breastfeeding difficulty (n=20)
• Unavailable of operator (n=10)
• No breast feeding (n = 229)
• TOTAL excluded ; 279

Patient Randomly Assigned (n = 71)

Breastfeeding Supplemental Sucrose

(n = 23) Breast Milk (n = 23) (n = 25)

No Failure
Treatment failure (2) No failure Exclusion (1)
Analyzed (23) Analyzed (23) Analyzed (24)
Baseline Criteria
 PIPP Score
Group n Unadjusted Adjusted

Group 1 23 7,00 (5,28-8,73) 7,04 (5,27-8,81)

Group 2 23 5,38 (3,65-7,01) 5,11 (3,39-6,84)

Group 1+2 46 6,19 (4,97-7,41) 6,08 (4,85-7,30)

Group 3 24 5,25 (3,56-6,94) 5,47 (3,74-7,20)

Point Difference
Outcome Comparing
Unadjusted Adjusted
(Group 1+2) and 0,94 (-1,15 to 3,02) 0,61 (-1,57 to 2,78)
Primary
Group 3 (p=0,37) (p=0,58)
Group 1 and 1,62 (-0,82 to 1,93) 1,93 (-0,57 to 4,42
Secondary
Group 2 (p=0,19) (p=0,13)
 COMFORT Neo Score
Group n Unadjusted Adjusted

Group 1 23 18,6 (16,9 to 20,3) 19,0 (17,3 to 20,7)

Group 2 23 16,5 (14,8 to 18,2) 16,3 (14,6 to 18,0)

Group 1+2 46 17,5 (16,4 to 18,7) 17,7 (16,5 to 18,8)

Group 3 24 16,0 (14,4 to 17,7) 15,8 (14,1 to 17,5)

Point Difference
Outcome Comparing
Unadjusted Adjusted
(Group 1+2) and 1,5 (- 0,5 to 3,5) 1,8 (-0,3 to 4,0)
Primary
Group 3 (p=0,14) (p=0,092)
Group 1 and 2,1 (-0,3 to 4,4) 2,7(0,3 to 5,1)
Secondary
Group 2 (p=0,09) (p=0,03)
DISCUSSION ..
..
• PAIN :
– Discomfort
Condition
PAIN PATHWAY
1. Breast feeding and
Supplemental breast milk
• Clinical Practice :
– Breast milk can give breastfed or bottle-fed
– Depend on mother attendance
• Skin to skin (breastfed), can be relief the
pain  so it’s assumed to be a better way
– But the PIPP score is not significantly
different.
2. PIPP and COMFORT neo,
• PIPP  Primary assessment tool in research
setting
– Higher ICC point
– But less applicable.
• COMFORTneo
– More applicable,
– Because it didn’t need to measure HR and O2
saturation
• PIPP and COMFORTneo
– Correlation coefficient  2; moderate corelation
LATE PRETERM
• Their immature pain responses
• Inadequate newborn sucking reflect

•  make no differences in this trial

CONCLUSION
• breast milk :
non-invasive, safe and natural method for pain
relief in late preterm infants.
• It can’t be concluded that breast milk has a
superior analgesic effect compared with
sucrose in late preterm infants during a
heel lance procedure, as was suggested
for term newborns in preceding trials.
CRITICAL
APPRAISAL
PICO
LATE PRETERM INFANT WHO HAD TO HAVE CLINICAL
POPULATION
BLOOD SAMPLE

INTERVENTION Breast Milk

COMPARISSON Sucrose

OUTCOME PAIN SCORE

ARE THE STUDY RESULTS
VALID?
1. Was the assignment of patients to treatment
randomized?
– Yes
2. Were the groups similar at the start of trial?
– Yes
3. Aside from the allocated treatment, were
groups treated equally?
– Yes
4. Were all patient who entered the trial accounted
for? And were they analyzed in the groups to
which they were randomized
– Yes
5. Were Measures objective or were the patients
and clinicians kept “BLIND” to which treatment
was being received?
– NO
WHAT WERE THE RESULTS?
• How large was the treatment effect?
• NNT can’t be calculated

• How precise was the estimate of the

treatment effect?
Will the result help me in caring for my
patient?
• Is my patient so different to those in the
study that the result cannot apply?
– No
• Is the treatment feasible in my setting
– Yes
• Will the potential benefits of treatment
outweigh the potential harms of treatment
for my patient
– No
CONCLUSION
• VALID
• IMPORTANT
• APPLICABLE

Level Of Evidence
• Ib
RECOMENDATION
• The breast milk can be used for relief the
pain of late preterm infant during a heel
lance procedure
THANK YOU