Evaluation of a New Lancet Device

(BD QuikHeel) on Pain Response and

Success of Procedure in Term Neonates
Vibhuti Shah, MD, MRCP(UK); Anna Taddio, BScPhm, MSc, PhD; Karthik Kulasekaran, MD;
Lisa OBrien, BSc; Esther Perkins, CNE; Edmond Kelly, FRCPC
Objective: To evaluate 2 heel lancet devices in terms
of pain response and success of the procedure in neo-
nates undergoing the newborn screening test.
Design: Randomized trial.
Setting: Tenth level, mother-and-baby unit of a univer-
sity-affiliated hospital.
Patients: Eighty term neonates.
Interventions: Heel lance using either the BD Safety-
Flow lancet (SF) or the BD QuikHeel lancet (QH).
Main Outcome Measures: Facial grimacing score
(brow bulge, eye squeezed shut, and nasolabial furrow
[range, 0%-100%]), cry duration, duration of the proce-
dure, and number of punctures required to collect the
blood.
Results: Forty neonates were enrolled in each group.
There were no differences in the demographic charac-
teristics between groups. During the first skin punc-
ture, the median score (25th-75th percentile) for facial
grimacing was 100% (76%-100%) for the SF compared
with 73% (42%-100%) for the QH (P=.02). For cry du-
ration, it was 6 seconds (0-9 seconds) vs 0 seconds (0-6
seconds), respectively (P=.01). Pain scores during blood
collection (ie, squeezing) did not differ between groups
(P=.09). The procedure took less time to performin the
QH group (140 seconds [90-236 seconds]) than in
the SF group (215 seconds [137-314 seconds]) (P=.02).
The total crying time was shorter in the QH group (90
seconds [66-196 seconds] vs 148 seconds [92-267 sec-
onds]; P=.03). Thirty-six (90%) of the neonates in the
QHgroup received 1 puncture for blood collection com-
pared with 21 (53%) in the SF group (P.001).
Conclusion: The BD QuikHeel lancet is superior to the
BD Safety-Flow lancet for blood collection in term neo-
nates undergoing the newborn screening test.
Arch Pediatr Adolesc Med. 2003;157:1075-1078
H
EEL LANCE is the tradi-
tional method for obtain-
ing blood samples inneo-
nates for the newborn
screening test and most
other hematologic and biochemical tests.
It is recognized that this technique causes
substantial pain.
1-3
Currently, the BD Safety-Flow lan-
cet (SF) (Becton Dickinson Vacutainer Sy-
tems, Franklin Lakes, NJ) (Figure 1) is
being used to perform heel lances in our
institution. The SF is a partially retract-
able automatic lancet witha widthof 1 mm
and a depth of 2.2 mm. Recently, a fully
retractable automatic lancet, the BD
QuikHeel (QH) (Becton Dickinson Vacu-
tainer Sytems) (Figure 2), was designed
for use during heel lance. Compared with
the SF, the QHproduces a wider but shal-
lower incision (blade width is 2.5 mmand
the depth is 1 mm). It is designed to reach
the superficial dermal blood vessels while
avoiding deepdermal painfibers andthere-
fore may cause less pain. In addition, the
QH may reduce the risk of skin puncture
andexposure toblood-borne pathogens for
operators compared with the SF because
of the fully retractable nature of its blade,
and it may offer better visibility of the site
location because of its tapered contact sur-
face. On the basis of the superior design
characteristics of the QH, we postulated
that the use of the QH would lead to a re-
duction in infant pain and in the dura-
tion of the procedure.
The objectives of this trial were to
compare the pain responses and success
of the procedure (time for blood collec-
tion, number of punctures) in term neo-
nates undergoing heel lance with the SF
compared with the QH.
ARTICLE
From the Departments of
Paediatrics (Drs Shah and
Kelly) and Nursing
(Ms Perkins), Mount Sinai
Hospital, Toronto, Ontario;
Faculty of Medicine (Drs Shah
and Kelly) and Graduate
Department of Pharmaceutical
Sciences, Faculty of Pharmacy
(Ms OBrien), University of
Toronto; Research Institute
and Neonatal Intensive Care,
Department of Pharmacy,
The Hospital for Sick Children,
Toronto (Dr Taddio); and
Department of Neonatology,
The Hospital for Sick Children
(Dr Kulasekaran).
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METHODS
This was a randomized, controlled trial conducted on the 10th
level, mother-and-baby unit of a university-affiliated hospital.
The study was approved by the local research ethics board, and
informed parental consent was obtained for all participants.
Healthy full-term neonates with a gestational age of 37 weeks
or more and weighing 2500 g or more at birth, who were un-
dergoing heel lance for the newborn screening blood test, were
recruited. Neonates with congenital abnormalities and those
exposed previously to a painful procedure other than the in-
tramuscular administration of vitamin K (eg, infants of dia-
betic mothers requiring blood glucose monitoring) were ex-
cluded. By means of a computer-generated list, neonates were
consecutively randomized to either the SF or the QHin blocks
of 10.
The heel lance was performed in a standardized manner by
the nurse responsible for the care of the infant on the day of the
study, and 0.4 mL of blood was collected for the test. The heel
lance consisted of 4 phases: baseline, cleaning the heel, heel lanc-
ing, and squeezing the heel (blood collection). Neonates were
videotaped during the entire procedure. A research assistant
blinded to the study hypotheses and group allocation subse-
quently made pain assessments from the videotapes. Pain was
assessed by means of facial grimacing score and cry duration.
The presence or absence of 3 facial actions (brow bulge, eyes
squeezed shut, and nasolabial furrow) was scored in 2-second
intervals for each phase of the procedure. The data were then
collapsed for each facial action into the percentage of time the
infant expressed the action. An overall pain score was then ob-
tained by summing the percentage scores for the 3 facial actions
andthendividing by 3. The score rangedfrom0%to100%. These
3 facial actions were chosen for the study, as they have been ob-
served in 99% of neonates within 6 seconds of heel lance and
are believed to be the most sensitive indicators of infant pain.
2
Cry duration was expressed in seconds. In addition, the dura-
tion of the procedure and the number of punctures required to
collect the blood sample were recorded.
To achieve a clinically significant reduction in pain scores
(20%) between groups, with 80% power and P.05, we esti-
mated a sample size of 35 neonates in each group. This sample
size was based onthe painscores obtained froma previous study
by our group.
4
A total of 80 neonates were enrolled to account
for possible dropouts and missing data, such as video record-
ing errors.
Demographic characteristics were compared between
groups by means of
2
analysis for categorical data and un-
paired t test for continuous data. Pain scores were compared
between groups by means of the Mann-Whitney test. A P.05
was considered significant.
RESULTS
Eighty neonates participated in the study; 40 were treated
with the SF and 40 with the QH. The demographic char-
acteristics of participating infants are shown in Table 1.
The median score (25th-75th percentile) for facial gri-
macing score during the first skin puncture was higher
in the SF group than the QH group (100% [76%-100%]
vs 73% [42%-100%]; P=.02). Neonates treated with the
SFcried for significantly longer during the first skinpunc-
ture (6 seconds [0-9 seconds] vs 0 seconds [0-6 sec-
onds]; P=.01) (Table 2). Pain scores during blood col-
lection (ie, squeezing) did not differ between groups
(Table 2). The procedure took less time to perform in
the QH group than the SF group (140 seconds [90-236
seconds] vs 215 seconds [137-314 seconds]; P=.02)
(Table 3). The total crying time was shorter in the QH
group than in the SF group (90 seconds [66-196 sec-
onds] vs 148 seconds [92-267 seconds]; P=.03) (Table
2). Ninety percent of the neonates in the QH group re-
ceived1puncture for bloodcollectioncomparedwith53%
for the SF group (P.001) (Table 3).
Figure 1. BD Safety-Flow lancet (Becton Dickinson Vacutainer Systems,
Franklin Lakes, NJ).
Figure 2. BD QuikHeel lancet (Becton Dickinson Vacutainer Systems,
Franklin Lakes, NJ).
Table 1. Demographic Characteristics of Study Subjects*
BD Safety-Flow
Lancet
(n = 40)
BD QuikHeel
Lancet
(n = 40)
Gestational age, mean SD, wk 39.7 1.2 39.6 1.2
Birth weight, mean SD, kg 3.4 0.4 3.4 0.4
Apgar score at 1 min, mean SD 8.8 0.5 8.7 0.6
Apgar score at 5 min, mean SD 9 0 9 0.2
Sex, No. (%) M 23 (58) 21 (53)
Vaginal delivery, No. (%) 31 (78) 26 (65)
Postnatal age, mean SD, h 30.6 6.5 32.6 8.4
*BD Safety-Flow and BD QuikHeel are trademarks of Becton Dickinson
Vacutainer Systems, Franklin Lakes, NJ.
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COMMENT
This is the first study, to our knowledge, that compared
2 automatic heel lancet devices, one with a partially re-
tractable blade (SF) and the other with a fully retract-
able blade (QH), for blood sampling in the newborn. In
this study, the QH was superior to the SF. The QH was
associated with less pain and a reduction in the blood
collection time and number of repeat punctures. The me-
dian total duration of crying was reduced by 58 seconds
(39%) and the time taken to obtain the blood sample was
reduced by 75 seconds (35%) in the QH group.
Heel lancing is the most common method of blood
sampling inthe newbornand causes intense pain.
1-3
There
is accumulating evidence that untreated procedural pain
inthe newbornmay leadto immediate andlong-termcon-
sequences, including conditioning and hyperalgesia.
5-7
Thus, caregivers should work toward preventing or re-
ducing pain in neonates. In recent reviews and consen-
sus statements, the regular provisionof analgesia andpain-
preventive strategies has been strongly recommended.
8-10
This study clearly demonstrated that the use of an alter-
native instrument (ie, the QH) for heel lancing can sig-
nificantly reduce pain from this procedure.
Several studies have evaluated the effect of conven-
tional manual lancets withautomated devices onpainand
distress, duration of the sampling time, and the amount
of hemolysis. McIntosh et al
11
showed that spring-
loaded lances (Autolet; Owen Mumford Ltd, Oxford, En-
gland) reducedpainanddistress associatedwithheel lanc-
ing. In another study, Paes et al
12
showed that an
automated incision device (Tenderfoot; International
Technidyne Corporation, Edison, NJ) was associated with
an increase in the amount of blood collected within a
shorter period and a decrease in the incidence of hemo-
lyzed sample in full-term neonates. Similarly, Vertanen
et al
13
evaluated a manual lancet (Microlance; Becton-
Dickinson, Meylan, France) and an automatic incision
device (Tenderfoot) in preterm infants undergoing re-
peated heel lances for blood sampling. The automated
incision device was associated with less bruising on the
heel, ankle, and leg and decreased heel inflammation. The
number of punctures to obtain a sufficient blood sample
was also reduced. Kazmierczak et al
14
evaluated the ex-
tent of hemolysis by measuring the hemoglobin content
in blood specimens collected with the Microlance or Ten-
derfoot and found that the use of the automated lance
was associated with lower levels of hemoglobin. The ex-
tent of hemolysis in blood samples was not evaluated in
our study.
Our study was not designed to evaluate nursing pref-
erences for the 2 lancets. However, anecdotal comments
were made by nurses that the QH was superior to the SF.
In fact, before the data analysis, nurses requested a change
in clinical practice from the SF to the QH. The approxi-
mate cost (in Canadian dollars) of an SF is $0.50 com-
pared with $2 for the QH. In our study, 47% of neonates
treated with the SF required more than 1 puncture to ob-
tain a blood sample, as compared with only 10% of neo-
nates in the QHgroup. Taking into consideration the cost
of repeat punctures for each group, the additional cost per
neonate to the health care systemif the QHis used instead
of the SF is $1.50. We believe that this additional cost is
justified because of the reduced procedure time and re-
duced pain associated with it.
Our study population was limited to healthy full-
term infants. The effectiveness of this device in the pre-
term population is unknown. The QH device is avail-
able for use in the pretermpopulation with a blade width
of 1.75 mmand a depth of 0.85 mm; however, it has not
been evaluated in a randomized controlled trial. Future
studies that address the effectiveness and safety (ie, re-
peated use) of this device in different populations should
be considered.
In conclusion, this study demonstrated that the BD
QuikHeel lancet causes less pain and a shorter proce-
dure than the BD Safety-Flow lancet in newborn infants
undergoing the newborn screening test. On the basis
of these results, our institution will now change to
the BD Quikheel lancet for collection of blood in term
neonates.
Accepted for publication July 21, 2003.
This study was partially funded by BDVacutainer Sys-
tems, Preanalytical Solutions, Franklin Lakes, NJ.
This study was presented at the annual meeting of the
Paediatric Research Societies; May 6, 2002; Baltimore, Md;
and the annual meeting of the Canadian Paediatric Soci-
ety; June 13, 2002; Toronto, Ontario.
Table 3. Success of the Procedure for BD Safety-Flow
and BD QuikHeel Lancet Devices*
BD Safety-Flow
Lancet
(n = 40)
BD QuikHeel
Lancet
(n = 40) P Value
One lance for blood
collection, No. (%)
21 (53) 36 (90) .001
Total time for lance and
blood collection, s,
median (quartile range)
215 (137-314) 140 (90-236) .02
*BD Safety-Flow and BD QuikHeel are trademarks of Becton Dickinson
Vacutainer Systems, Franklin Lakes, NJ.
Table 2. Pain Scores During Heel Lance
With BD Safety-Flow and BD QuikHeel Lancet Devices*
BD Safety-Flow
Lancet
(n = 40)
BD QuickHeel
Lancet
(n = 40)
P
Value
Facial grimacing score, %
Baseline 0 (0-0) 0 (0-0) .08
Cleaning heel 0 (0-6) 0 (0-58) .06
Heel lance phase 100 (76-100) 73 (42-100) .02
Squeeze (blood collection) 100 (100-100) 100 (53-100) .09
Cry duration, s
Baseline 0 (0-0) 0 (0-0) .98
Cleaning heel 0 (0-0) 0 (0-0) .26
Heel lance phase 6 (0-9) 0 (0-6) .01
Squeeze (blood collection) 97 (56-153) 81 (59-119) .36
Total crying time, s 148 (92-267) 90 (66-196) .03
*Values are median (quartile range). BD Safety-Flow and BD QuikHeel are
trademarks of Becton Dickinson Vacutainer Systems, Franklin Lakes, NJ.
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We are grateful to the parents of the participating neo-
nates, to the nursing staff from the 10th level, mother-and-
baby unit of Mount Sinai Hospital, Toronto, and to Lucia
Taddio and Erwin Darra for aspects of videotape analysis.
Correspondingauthor: Vibhuti Shah, MD, MRCP(UK),
Department of Paediatrics, Room 775A, Mount Sinai Hos-
pital, 600 University Ave, Toronto, Ontario, Canada M5G
1X8 (e-mail: vshah@mtsinai.on.ca).
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What This Study Adds
Heel lance, the conventional method of blood collec-
tion in newborns, is a very painful procedure. Previous
studies have demonstrated that automatic lancets are bet-
ter than manual lancets. This is the first study, to our
knowledge, to compare 2 automatic heel lancet devices,
one with a partially retractable blade and the other with
a fully retractable blade, for blood sampling in the new-
born. The fully retractable automatic lancet was associ-
ated with less pain, a reduction in sampling time, and
fewer repeat punctures. On the basis of the results of the
study, our institution is using the fully retractable au-
tomatic lancet for blood collection in term newborns.
Call for Papers
The Archives of Pediatrics &Adolescent Medicine will pub-
lish a theme issue on mental health in August 2004. Our
call for papers includes studies that provide new infor-
mation on office screening for mental health problems,
and guidance to practitioners on appropriate care and
referral of patients with mental illness. We are espe-
cially interested in randomized trials that test new in-
terventions, particularly those that can be provided by
primary care physicians. For the best chance of consid-
eration for this theme issue, papers should be received
by January 1, 2004. Please consult our Web site
(www.archpediatrics.com) for detailed instructions for
authors.
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