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Indian Pediatr 2013;50:
1011-1015 |
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Effect of Kangaroo Mother Care Vs
Expressed Breast Milk Administration on Pain Associated with
Removal of Adhesive Tape in Very Low Birth Weight Neonates:
A
Randomized Controlled Trial
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Ruchi N Nanavati, Rajiv Balan and Nandkishor S Kabra
From Department of Neonatology, Seth GS Medical College and KEM
Hospital, Acharya Donde Marg, Parel, Mumbai 400 012, India.
Correspondence to : Dr Nandkishor S Kabra, Department of Neonatology,
Seth GS Medical College and KEM Hospital,
Acharya Donde Marg, Parel, Mumbai 400012, Maharashtra, India.
Email: [email protected]
Received: April 18, 2012;
Initial review: May 22, 2012;
Accepted: April 26, 2013.
Published online: May 5, 2013.
PII: S097475591200346
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Objective: To compare the pain relief effect of Kangaroo Mother Care
(KMC) and Expressed Breast Milk (EBM) on the pain associated with
adhesive tape removal in very low birth weight (VLBW) neonates.
Design: Randomized Controlled Trial.
Setting: Neonatal intensive care unit of a
tertiary care teaching hospital.
Participants: 15 VLBW neonates who needed
adhesive tape removal for the first part and 50 VLBW neonates needing
adhesive tape removal for the second part.
Methods: In first stage of the study, we studied
whether adhesive tape removal in VLBW neonates was painful. In the
second stage, eligible VLBW neonates were randomised to compare the
efficacy of KMC and EBM in reducing the pain during the procedure of
adhesive tape removal.
Outcome Variables: Premature Infant Pain Profile
(PIPP) Score, heart rate, oxygen saturation.
Results: There was significant increase in pain
associated with the removal of adhesive tape (Mean pre-procedure PIPP
score 3.47 ± 0.74; post-procedure mean PIPP score 12.13 ± 2.59; P<0.0001).
The post intervention mean PIPP pain score was not significantly
different between the KMC and EBM groups
(P= 0.62).
Conclusions: Removal of adhesive tape is a
painful procedure for VLBW neonates. There was no difference between KMC
and EBM in relieving pain associated with adhesive tape removal.
Key words: Pain, Analgesia, Preterm, Newborn, Adhesive
removal.
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T ill recently the management of
pain in the
newborn was hampered by the lack of
awareness among the healthcare professionals
that the neonate is capable of perceiving pain [1,2].
With increasing awareness of pain in neonates,
pain relieving measures are undertaken during NICU procedures like
endotracheal intubation, heel-prick, chest drain insertion, etc. but not
during many other routinely performed procedures [1]. Adhesive tapes are
used in neonates for several procedures like fixing of intravenous
cannula, arterial lines, temperature probes and endotracheal tubes. Even
a simple procedure such as removal of adhesive tape may cause pain in
neonates [1]. Currently no
pain relieving measures are undertaken during adhesive tape removal in
day-to-day practice.
Clinical studies have shown beneficial effects of
pharmacological as well as non-pharmacological interventions in
decreasing neonatal pain and stress [1,3-17].
Non-pharmacological interventions are based on the
implementation of neurobehaviorally supportive relationship-based care
during the actual procedure [4,5,11,12].
Both provision of KMC and EBM are proved to be
non-pharmacological interventions to reduce pain in neonates [1,3,6,16].
We conducted this study in two stages. In first stage
of the study, we assessed whether removal of adhesive tape in very low
birth weight (VLBW) neonates is a painful procedure or not. After
demonstrating that removal of adhesive tape is indeed a painful
procedure, in the second stage of the study, we evaluated the
comparative efficacy of KMC and EBM in VLBW neonates on pain-relief
during removal of adhesive tape.
Methods
This prospective study was carried out from June to
August 2010 in the Neonatal Intensive Care Unit of Department of
Neonatology at Seth G S Medical College and KEM Hospital after obtaining
approval from the Institutional Ethics Committee. VLBW infants requiring
removal of adhesive tape (Micropore Medical Tape, 3M) during removal of
intravenous cannula were enrolled after obtaining informed consent from
parents. Neonates with neurological abnormalities and major congenital
defects and those receiving sedatives or analgesics were excluded from
the study.
Assessment of pain: Pain assessment during
removal of adhesive tape was performed by using the Premature Infant
Pain Profile (PIPP) score [17,18]. The total PIPP score varies for
various gestational ages. For all age groups a total score of
£6 indicates
minimal/no pain while a score of ³12
indicates moderate to severe pain.
The behavioral state in the neonate was scored by
observing the baby for 15 seconds before the intervention by observing
the infant’s activity, status of eye (eyes open or closed), and facial
movements. The baseline heart rate and oxygen saturation were recorded.
A neonatal nurse was then instructed to remove the adhesive tape. The
baby was observed for 30 seconds following the intervention and the
above-mentioned parameters were recorded again. The heart rate and
oxygen saturation were recorded by the investigator. A separate
assistant trained to assess the PIPP profile recorded the facial
characteristics.
This study was performed in two stages. In first
stage of study, we used PIPP score, heart rate, and oxygen saturations
to assess whether removal of adhesive tape in VLBW neonates is a painful
procedure or not. In this study the PIPP pain scores, heart rate and
oxygen satuarions were recorded before and after the removal of adhesive
tape and compared.
In the second stage of the study, the effect of KMC
and EBM on pain during removal of adhesive tape in VLBW neonates was
assessed. The babies were randomized to receive either KMC or EBM. A
computer-generated randomization sequence was used to assign infants to
two treatment groups in 1:1 ratio. Randomisation was balanced in
variable random blocks of two or four patients. Treatment allocations
were inserted in sequentially numbered opaque envelopes and were sealed.
Just prior to adhesive tape removal, a neonatal research nurse opened
the sequentially numbered envelopes. This neonatal nurse was responsible
for adhesive tape removal.
In KMC group, the baby was kept in Kangaroo Mother
Care for 15 minutes before the removal of the adhesive tape. In EBM
group, a swab soaked in EBM was kept in the baby’s mouth for 2 minutes
before the removal of the adhesive tape and continued during the
intervention.
Sample size for first stage of the study was
calculated by using formula for hypothesis of one sample mean.
Hypothesizing a pre-procedure score of 5 and post procedure pain score
of 7 with allowable difference of 0.1 and expected variance of 0.01 ( a
error of 0.05 and
b error of
0.10 and power of 90%), the estimated sample size was 11 subjects.
Sample size calculation for the second stage of the study was calculated
by the formula for hypothesis of two parallel sample means. Allowable
difference of 0.08 (8%) and expected variance of 0.01 (a
error of 0.05,
b error of
0.20 and power of 80%) the estimated sample size was 25 subjects in each
group.
Statistical analysis: The mean and
standard deviation of the total pain score as well as that of each of
the indicator of the PIPP scale were calculated. In first stage of the
study PIPP score, heart rate and oxygen saturations results were
analyzed using two-tailed paired t test. In second stage of the
study, baseline characteristics of enrolled infants were compared by
chi-square test for categorical variables and unpaired t test or Mann
Whitney U test for continuous variables as appropriate. In second stage
of the study, post-procedure PIPP score and its components were compared
by two-tailed unpaired t test or Mann Whitney U test as
appropriate. Statistical significance was accepted for values P<0.05.
All the statistical tests were performed by using the Minitab (version
15) statistical software for Windows.
Results
In first stage of this study, 15 VLBW babies were
enrolled (birth weight in grams, mean ± SD, 1254.67±135.43; gestational
age in weeks, mean ± SD, 32.33±1.35). Results of this part of study are
summarized in Table I. There was a significant increase in
PIPP score with the removal of adhesive tape (P<0.0001).
TABLE I Change in Various Parameters During Adhesive Tape Removal (n=15)
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Variable |
Pre-procedure (n=15) |
Post-procedure (n=15) |
Mean difference (95 % CI) |
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PIPP score |
3.47(0.74) |
12.13(2.59) |
-8.66(-9.91 to -7.42) |
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Heart rate
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140.80(11.48) |
152.53(10.92) |
-11.73(15.78 to -7.69) |
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Oxygen saturation
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94.53(1.73) |
90.33(3.46) |
4.20(2.54 to 5.86) |
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*All values in mean (sd); All P<0.0001. |
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Fig. 1 Flowchart of infants enrolled
in second part of the study.
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In the second part of the study, 66 VLBW neonates
were deemed to be eligible for enrollment in the study. Sixteen infants
were excluded for various reasons (Fig. 1). The final
analysis included 50 babies. The baseline characteristics of infants at
randomization were similar in two groups except the infants in KMC group
were slightly heavier in weight than those in EBM group (Table
II).
TABLE II Baseline Characteristics of The Infants Enrolled in Second Stage of The Study
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Baseline Characteristics |
KMC Group (n=25) |
EBM Group (n=25) |
P value |
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Male
|
13.00 |
13.00 |
1.00 |
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Birth weight (g)
|
1352.76(150.12) |
1235.48(169.12) |
0.01 |
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Gestational age (weeks)
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32.72(2.03) |
32.40(2.16) |
0.59 |
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Postnatal age (d)
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7.12(6.64) |
5.40(3.65) |
0.26 |
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Oxygen saturation (%)
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95.04(2.50) |
96.04(2.89) |
0.19 |
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Heart rate per minute
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149.68(13.78) |
148.20(15.48) |
0.72 |
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KMC: Kangaroo mother care; EBM: Expressed breast milk; all
values in mean (SD). |
The post-intervention PIPP pain score in the KMC
group and EBM group indicated minor or no pain. The difference between
the post-intervention mean PIPP pain score was not significantly
different between the KMC and EBM groups (Table III).
These mean PIPP pain scores during adhesive tape removal in both the
groups (KMC and EBM) were significantly lower as compared to the
post-procedure PIPP scores that were observed in infants enrolled in
first stage of the study. The various indicator components of PIPP
scores, except for exception of Behavioral state points, were
statistically not different between the two groups.
TABLE III Post Procedure PIPP Score and its Components in EBM and KMC Group
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Variables
|
KMC Group (n=25) |
EBM Group (n=25) |
Mean difference
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P value
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|
mean ± SD |
mean ± SD (n=25) |
(95 % CI) |
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PIPP Score |
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Median
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5.92 ± 1.89 |
6.20 ± 2.10 |
- 0.28 (- 1.42, 0.86) |
0.62 |
|
interquartile range |
6.0 |
5.0 |
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4.5 to7.0 |
5.0 to 7.5 |
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0.98
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Components of PIPP Score |
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Gestational age points |
1.00 ± 0.41 |
1.28 ± 0.74 |
-0.28 (-0.62, 0.06) |
0.10 |
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Behavioral state points |
1.84 ± 0.94 |
1.20 ± 0.76
|
0.64 (0.15, 1.13) |
0.011 |
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Median (range) |
2.0 (0.0 to 3.0)
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1.0 (0.0 to 2.0)
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0.023
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interquartile range
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1.0 to 3.0
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1.0 to 2.0
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Heart rate points |
0.32 ± 0.63
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0.16 ± 0.37
|
0.16 (-0.13, 0.45) |
0.28 |
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Oxygen saturation points |
0.16 ± 0.47 |
0.04 ± 0.20 |
0.12 (-0.90, 0.33) |
0.25 |
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Brow bulge points |
0.72 ± 0.54
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0.92 ± 0.76
|
-0.20 (-0.58, 0.18) |
0.29 |
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Eye squeeze points |
0.96 ± 0.89
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1.44 ± 0.82
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-0.48 (-0.97, 0.01) |
0.06 |
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Nasolabial furrow points |
0.76 ± 0.72
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1.08 ± 0.70 |
-0.03 (-0.73, 0.09) |
0.12 |
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All values in mean (SD) unless stated. |
Discussion
This study demonstrated that removal of adhesive tape
is a painful procedure. This study also established that both KMC and
EBM can provide pain relief in babies (whose adhesive tapes are being
removed) as assessed by PIPP score. There was no statistically
significant difference between KMC and EBM in relieving the pain
associated with adhesive tape removal.
The babies in the KMC group may score higher in the
behavioral component of the PIPP profile for physiological reasons; this
was observed in our study. It is imperative to note that the behavioral
component under the PIPP scale is graded from 0-3 points with active
alert state scoring less on the pain scale (0 points) and sleepy state
being given the highest points (3 points) [17]. It is a well-known fact
that skin-to-skin contact with KMC is known to induce sleep state.
Strengths of our study were: robust randomized
controlled trial design, sufficient sample size with adequate power to
detect a difference if there was one, and use of PIPP score for
assessment of pain. This is the only study to date which evaluated the
pain reducing interventions during adhesive tape removal in neonates.
There are no studies in literature that have evaluated the effect of any
intervention in amelioration of pain associated with removal of adhesive
tape. Limitations of our study are: lack of blinding of outcome
measures, use of PIPP in real time as opposed to videotaping for
subsequent analysis, and single assessor with no inter-rater reliability
checks. Additional limitation of our study was that we have only
assessed short term outcomes.
In our study, with the provision of KMC during the
removal of adhesive tape, we found a significant decrease in PIPP pain
score. Loss of parental role and the pain the infant experiences in NICU
are reported as being the most stressful aspects of having an infant in
the intensive care setting. This has lead to several studies to explore
the means of involving mothers to provide comfort during painful events.
Thus for the very preterm group, skin-to-skin maternal contact or KMC
would appear to be a method which could decrease pain response and
provide mother an opportunity to comfort her infant during painful
procedures in a technologically invasive environment. The study
conducted to evaluate the effect of skin-to-skin contact of full-term
neonates with mothers during heel lance showed significant decrease in
crying and heart rate acceleration [7]. Kangaroo care is shown to have
positive effects on autonomic behavior and sleep state [9,10,15]. Sleep
state has been associated with decreased pain response and KMC increases
the amount of time in the sleep state. Facilitated tucking which is
similar to provision of KMC is also an effective comfort measure in
attenuating premature infants’ responses to minor pain [5,11,12].
Recently published studies demonstrated the
effectiveness of EBM in providing pain relief [19,20]. In a Cochrane
review that assessed the impact of breastfeeding or breast milk for
procedural pain, it was noted that neonates in the breastfeeding group
had statistically significantly less increase in the heart rate, reduced
duration of crying during procedure compared to swaddled group or
pacifier group [14].
Components of breastfeeding that may be responsible include presence of
a comforting person (mother), physical sensation (skin-to-skin contact
with comforting person), diversion of attention, and sweetness of
breastmilk (presence of lactose or other ingredients present in the
breast milk). Results from one study indicate that it may be the contact
of breast-feeding, as opposed to the breastmilk, which is efficacious
[13]. Preterm neonates incapable of direct breastfeeding from the mother
may benefit from placement of breast milk on the tongue or administering
breast milk via the nasogastric or orogastric route. One study found
that rocking or giving a baby a pacifier are more effective
non-pharmacological analgesics than EBM, dextrose, sucrose or massage
for the pain of heel pricks in neonates [15].
Our study results suggest that neonatal units need to
include removal of adhesive tape as one of the procedure that can cause
pain in VLBW neonates. KMC or EBM or other pain relief measures should
be provided during adhesive tape removal in VLBW neonates.
Acknowledgements: Dean, Seth GS Medical College
and KEM Hospital, Mumbai for permitting us to publish the manuscript.
Contributors: RNN: management of patients,
designing of study, and drafting the manuscript; RB: review of
literature, data collection and writing the first draft; NSK: drafting
the article, analysis and interpretation of data. NSK will act as
guarantor. The final manuscript was approved by all the authors.
Funding: None; Competing interests: None
stated.
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What Is Already Known?
• There are no studies on assessment and management of pain
associated with adhesive tape removal.
What This Study Adds?
•
Removal of adhesive tape is a painful procedure for VLBW
neonates
•
Giving Kangaroo mother
care or providing expressed breast-milk during procedure can
relieve pain associated with adhesive tape removal.
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