Topical Anesthetics for Intravenous Insertion in Children: A Randomized
Equivalency Study
Charmaine Kleiber, RN, PhD*; Mark Sorenson, RPh‡; Kathy Whiteside, CCLS§;
B. Ann Gronstal, RN, MSN*; and Raymond Tannous, MD储
ABSTRACT. Objectives. Children view needle sticks
as the worst source of pain and fear in the hospital
setting. In an effort to minimize the pain of needle sticks,
the use of eutectic mixture of lidocaine and prilocaine
(EMLA) has become standard practice in many children’s
hospitals. Unfortunately, EMLA requires at least 60 min-
utes to be fully effective and reportedly may cause vaso-
constriction, leading to difficult vein cannulation. A
newly available local anesthetic (ELA-Max) may require
less time and cause less vasoconstriction. The purpose of
this randomized crossover study was to investigate the
anesthetic equivalence of EMLA and ELA-Max.
Methods. Thirty well children (14 girls and 16 boys)
who were between the ages of 7 and 13 years volunteered
to have EMLA applied to the dorsal aspect of 1 hand for
60 minutes and ELA-Max applied to the other hand for 30
minutes. Right and left hands were randomized to treat-
ment type and order of intravenous (IV) insertion. Clin-
ical Research Center nurses, blind to the anesthetic ran-
domization, attempted to insert a 22-gauge Teflon IV
catheter into a vein in each hand. The children rated pain
during IV insertion on the Oucher scale, and the nurse
rated the difficulty of the insertion.
Results. There was no significant difference in pain
ratings for hands that were treated with EMLA (mean:
20.5) or with ELA-Max (mean: 24), and there was no
difference for the difficulty of vein cannulation. Chil-
dren’s preprocedure state anxiety was positively associ-
ated with pain ratings.
Conclusions. ELA-Max, applied for 30 minutes before
IV cannulation, has an anesthetic effectiveness similar to
EMLA applied for 60 minutes. Some children rated IV
insertion pain fairly high for both hands (eg, 60 on a 0- to
100-point scale) despite anesthetic treatment. Preproce-
dural anxiety may affect the perception and/or rating of
pain. There were no differences between hands that were
treated with EMLA or with ELA-Max for success of IV
insertion. Pediatrics 2002;110:758 –761; pain, children, veni-
puncture, topical anesthetic.
ABBREVIATIONS. IV, intravenous; EMLA, eutectic mixture of
lidocaine and prilocaine; CRC, Clinical Research Center.
From the Departments of *Nursing, ‡Pharmacy, §Rehabilitation Therapies,
and 储Pediatrics, Children’s Hospital of Iowa with University of Iowa Health
Care, Iowa City, Iowa.
Received for publication Sep 4, 2001; accepted Mar 19, 2002.
Reprint requests to (C.K.) Children’s Hospital of Iowa, University of Iowa
Hospitals and Clinics, Children’s and Women’s Services, 200 Hawkins Dr,
Iowa City, IA 52242-1083. E-mail: charmaine-kleiber@uiowa.edu
PEDIATRICS (ISSN 0031 4005). Copyright © 2002 by the American Acad-
emy of Pediatrics.
758 PEDIATRICS Vol. 110from
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4 October 2002 at Philippines:AAP Sponsored on February 25, 2020
V
enipuncture for laboratory tests and intra-
venous (IV) insertion are common medical
procedures, and many children with chronic
illnesses have these procedures done repeatedly dur-
ing the course of their treatment. Needle insertion is
the most frightening and bothersome medical proce-
dure for children.1 Studies have shown that chil-
dren’s previous distress during medical procedures
is a predictor of future distress.2– 4 Some children
develop needle phobia that is extremely difficult to
treat.
Topical anesthetic creams have been developed to
minimize the discomfort of venipuncture and many
children’s hospitals have adopted the use of eutectic
mixture of lidocaine and prilocaine (EMLA) as part
of their pain management standard of practice. Nu-
merous studies have shown that EMLA decreases
pain sensation for children during needle sticks.4 –7
The anesthetic is more effective for simple venipunc-
ture than for IV cannulation.5
Despite the effectiveness of EMLA, some practitio-
ners choose not to use it. Time is 1 issue. The medi-
cation must be left on the skin for at least 60 minutes
to be effective. Also, EMLA may constrict the vein,
making IV cannulation more difficult.8 A recently
marketed 4% lidocaine cream known as ELA-Max
may act more quickly and may produce less vaso-
constriction. The manufacturer suggests that ELA-
Max provides dermal anesthesia after 30 minutes.
ELA-Max is a nonprescription lidocaine cream. The
lidocaine molecules are encapsulated in a lipid layer,
which reportedly enhances absorption into the der-
mal layers. No published studies have evaluated the
efficacy of ELA-Max cream during venipuncture in
children.
The purpose of this study was to assess the equiv-
alence of 2 commercially available local anesthetics:
EMLA and ELA-Max. The research hypotheses were
that there is no significant difference for pain sensa-
tion with IV insertion between hands that are treated
with EMLA or with ELA-Max and that there is no
significant difference for ease of IV insertion.
METHODS
Materials
EMLA cream (AstraZeneca Pharmaceutical LP, Wilmington,
DE) is an emulsion in which the oil phase is a eutectic mixture of
lidocaine and prilocaine in a ratio of 1:1 by weight. The eutectic
mixture has a melting point below room temperature; therefore,
both anesthetics exist as a liquid oil rather than as crystals. Each
gram of EMLA cream contains 25 mg of lidocaine, 25 mg of
prilocaine, emulsifiers, thickening agents, sodium hydroxide to
adjust the product to a pH approximating 9, and purified water.
EMLA cream is commercially available by prescription only.
ELA-Max (Ferndale Laboratories, Inc, Ferndale, MI) is a topical
anesthetic cream that contains only lidocaine as an anesthetic
agent. Each gram of ELA-Max contains 40 mg of lidocaine, leci-
thin, propylene glycol, carbomer 940, benzyl alcohol, vitamin E
acetate, cholesterol, triethanolamine, polysorbate 80, and purified
water. ELA-Max is commercially available as an over-the-counter
medication. Ferndale Laboratories provided ELA-Max samples for
this study.
Sample
This study was approved by the institutional review board and
was conducted in the Clinical Research Center (CRC) at the Uni-
versity of Iowa Hospitals and Clinics. Local advertisements in-
vited children between the ages of 7 and 13 years to volunteer for
this study. This age group was chosen for 2 reasons. At 7 years,
children are more likely to understand the assent process, and
they are more reliable when reporting sensations such as pain.
With the onset of puberty, around 13 years, children develop
larger veins that are easier to cannulate. All of the children who
volunteered for this study were in age-appropriate school grades,
had normal sensation on the dorsal aspect of the hands, and had
no history of allergy or reaction to lidocaine ointments or injec-
tions. Parents signed written consent, and the children gave verbal
and written assent for study procedures.
Procedure
Children were randomized to have EMLA placed on the dor-
sum of the right or left hand. Either an investigator or 1 of the CRC
nurses marked a vein on the hand, applied 2.5 g of EMLA on the
mark, and placed a semiocclusive dressing over the ointment. The
application time was recorded. Thirty minutes later, 2.5 g of ELA-
Max was applied to the opposite hand in the same manner. When
the EMLA had been in place for 60 minutes, it was removed and
the hand was wiped clean. The ELA-Max was removed in the
same manner after it had been in place for 30 minutes.
While the children were waiting for the anesthetics to take
effect, they were asked to rate their current level of anxiety on a
10-point vertical thermometer-like scale. They were also asked
about previous experiences with needle sticks and their usual
coping styles. Most of the waiting time was spent watching tele-
vision or reading.
Within 10 minutes after the anesthetics were removed, a CRC
nurse, who was blind to the type of anesthetic on each hand,
inserted a 22-gauge Teflon IV catheter into the vein on 1 hand. The
order of right and left hands for IV insertion was randomized.
During the IV placement, the children were recumbent, blocked
from watching the needle stick, and asked to concentrate on the
sensations in the hand. When the nurse either cannulated the vein
or felt that it was not possible to cannulate without extensive
maneuvering, the child was asked to rate his or her pain on the
Oucher scale. The needle was then removed, an adhesive bandage
was placed, and the nurses rated the difficulty of the IV place-
ment. The procedure was repeated on the opposite hand. The
children received $40 for their participation in the study.
Instruments
The Oucher is used to assess pain intensity in children as young
as 3 years and includes 2 separate scales.9 One is a series of 6
photographs showing a child in varying degrees of discomfort
and is used by children who are unable to count by number.
Children who are able to count to 100 by ones or tens and can
identify the larger of 2 numbers use the vertical numeric scale
(0 –100) that is printed next to the faces. All of the children in this
study were able to use the numeric scale. The Oucher has been
tested for validity and reliability9 and is widely used for clinical
and research purposes. The correlation between the Oucher and
the Visual Analog Scale for pain has been reported to be 0.89 (P ⬍
.01). Discriminant validity was established by investigating the
relationships between the Oucher and 2 fear report measures. The
associations between the numerical Oucher scale and the Hospital
Fears Rating Scale and Scare Scale were very low, with Gamma
coefficients of ⫺0.003 and 0.075, respectively.10
In this study, anxiety was measured because anxious feelings
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have been shown to influence pain perception. The validity of
comprehensive state anxiety scales for children, such as the State-
Trait Anxiety Inventory for Children, have recently been ques-
tioned.11 Visual analog scales have been recommended as a simple
way to assess state anxiety.12 Therefore, children’s self-report of
state anxiety was measured with a thermometer-like scale. The
thermometer scale is a vertical measure divided by 10 evenly
spaced marks. The instructions to the children are, “Pretend that
all of your worried or anxious feelings are in the bulb or bottom
part of the thermometer. If you have a little bit of anxiety or worry,
the feelings might come up in the thermometer just a little bit. If
you have a lot of worry or anxiety, the feelings might go up, even
all the way to the top. Put a line on the thermometer showing
where your anxiety or worry level is right now.”
Ease of IV insertion was rated by the CRC nurse using 5
categories of difficulty: vein easy to find, vein a little difficult to
find, vein difficult to find, vein very difficult to find and cannulate,
and unable to cannulate vein. The CRC nurses are expert in IV
cannulation and perform venipuncture for children in research
studies as part of their routine practice.
Data Analysis
A power analysis for testing the pain prevention equivalency of
the 2 anesthetics was based on data obtained in our previous
study.4 With ␣ set at 0.05, a sample of 30 subjects gave a power of
0.9 to detect a 10-point difference on the 0- to 100-point pain scale.
Data were entered into an SPSS database (SPSS, Inc, Chicago, IL),
double-checked, and analyzed with nonparametric statistics for
paired data.
RESULTS
Fourteen girls and 16 boys volunteered to be in
this study. None of the children withdrew before
completing the study. The children ranged in age
from 7.4 to 12.9 years (mean: 10.8 years). All of the
children were English speaking, white, and in the
school grade appropriate for their age. Most of the
children had no experience with painful medical pro-
cedures or needle sticks other than routine immuni-
zations and dental examinations. Four of the children
had a history of stitches for accidental cuts, 2 had had
minor surgery, 1 had had a tooth pulled, and 1 had
had allergy shots. Only a few children identified
specific coping strategies, such as holding a parent’s
hand or thinking of happy things, for dealing with
potentially painful medical procedures. Seventeen of
the children said that they preferred not to watch the
needle stick, 8 preferred to watch, and 5 stated that
they had no preference. The children’s self-reported
anxiety scores before the IV sticks ranged from 0 to 9
on the 10-point thermometer scale. The median anx-
iety score was 1, with a mean of 2.4 (⫾2.3).
Pain scores on the Oucher scale ranged from 0 to
70 (mean: 20.5 ⫾ 22.7) for the hand that was treated
with EMLA and from 0 to 60 (mean: 24 ⫾ 17.6) for
the hand that was treated with ELA-Max (Table 1).
The Wilcoxon signed ranks test for paired data
showed no significant difference (z ⫽ ⫺1.01; P ⫽ .31).
Paired differences (individual subjects’ ELA-Max
hand score minus the EMLA hand score) are dis-
TABLE 1. Oucher Pain Scores
Pain Score (0 to 100) EMLA ELA-Max
(n ⫽ 30) (n ⫽ 30)
Range 0–70 0–60
Median 10 25
Mean and standard deviation 20.5 (22.7) 24 (17.6)
No significant difference (P ⫽ .31).
759
Fig 1. Difference between pain at IV site treated
with ELA-Max and IV site treated with EMLA.
played in Fig 1. The Mann-Whitney U test did not
show a significant association between order of IV
stick and pain ratings or between gender and pain
ratings. There was a positive association (r ⫽ 0.399;
P ⫽ .029) between anxiety ratings and average pain
scores.
The CRC nurses rated ease of IV stick on a 5-point
scale. For the 60 IV sticks (2 per subject), 21 were
rated “easy,” 14 were “a little difficult but needle
went right in,” 2 were rated “difficult to find vein,”
and 23 were rated “unable to cannulate vein.” The
scores were collapsed into 2 categories to determine
differences. Category 1 included all successful can-
nulations, no matter how difficult, and category 2
comprised unsuccessful cannulations (Table 2). For
14 of the children, IV insertion was successful in both
hands; for 7 children, the nurse was unable to can-
nulate either hand. Cannulation was successful for
the EMLA-treated hand and unsuccessful for the
ELA-Max-treated hand in 3 children, and the oppo-
site occurred in 6 children. The McNemar cross-
tabulation test showed no significant difference for
success in vein cannulation (P ⫽ .508).
DISCUSSION
EMLA and ELA-Max seem to be equally effective
local anesthetics for IV insertion. A positive aspect of
ELA-Max is that it is effective after just 30 minutes.
For this study of children, the ELA-Max manufac-
turer (Ferndale Laboratory) recommended that we
use a semiocclusive dressing over the anesthetic
cream, to ensure that the cream stays in place. It is
not known whether the dressing was a factor in the
effectiveness of the product. Clinically, however, a
dressing is a very practical part of applying local
analgesia, because children may have difficulty stay-
ing inactive enough to keep the cream in place.
A strength of this study is that the subjects were
relatively naı̈ve to medical procedures and voluntar-
ily had needles placed. The children were able to lie
TABLE 2. IV Cannulation Success or Failure
Hand Treated With
ELA-Max
Successful Unsuccessful
Hand treated Successful 14 3 match that of EMLA. The EMLA dosage limit for
with EMLA Unsuccessful 6 7
No significant group differences between EMLA and ELA-Max
(P ⫽ .508).
760 TOPICAL ANESTHETICS FOR IV INSERTION IN CHILDREN
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still and concentrate on the sensations felt during
needle sticks. Had this study been done with chil-
dren who needed IV placement for medical treat-
ment, there may have been some question about the
validity of the pain scores. Children’s pain percep-
tion can be influenced by previous experiences, anx-
iety, and coping mechanisms. Children who have
had numerous needle sticks may be sensitized to
needle pain and thus report more pain.
The strength of the study design is also a limita-
tion. The children who volunteered for this study
certainly were not bothered by the thought of nee-
dles, and they may have had higher-than-average
pain thresholds. However, the range of pain scores
(0 –70) indicates individual variation in either pain
sensitivity or effectiveness of local anesthetics. Only
10 subjects reported pain at 10 or less for both of the
needle sticks. Another 10 children reported pain at 30
or more for both needle sticks. It seems that for some
children, these 2 local anesthetics just do not work
very well. Our conclusion is that EMLA and ELA-
Max are equally effective and equally ineffective for
needle insertion pain. However, it should be noted
that all of the children in this study were white. The
effectiveness of these medications for people with
different skin tones should be investigated.
This study found no significant difference between
EMLA and ELA-Max for success of IV cannulation.
Successful vein cannulation occurred with 60% of the
hands that were treated with EMLA and 67% of the
hands that were treated with ELA-Max. These num-
bers are somewhat lower than reported elsewhere.
Squire et al13 reported successful IV cannulation in
84% of veins that were treated with EMLA. A possi-
ble explanation is that the CRC nurses, knowing that
the IV was not needed for clinical reasons and would
be removed immediately, were not very aggressive
in maneuvering the needle. They were asked to make
a “reasonable” effort to cannulate the vein.
An advantage of the ELA-Max product is that it
contains only lidocaine and therefore does not carry
with it the risk of triggering methemoglobinemia.
This may be of particular importance when treating
neonatal patients. Although the package insert for
ELA-Max does not address use in infants, our Divi-
sion of Neonatology decided that its use should
infants from 37 weeks’ gestational age to 3 months is
1 g per day, to cover no more than 10 cm2.
Another difference between the 2 products is that
a semiocclusive dressing is not necessary for ELA-
Max, according to the manufacturer. In practice, it
would be easy to contain the cream on the skin by
simply putting a cotton ball over the cream and then
wrapping the site with a clear plastic wrap.
At the time that this study was done, the cost of the
2 products was approximately the same. Our hospi-
tal decided to stock both products until there is a
clear preference for one. We were hesitant to elimi-
nate EMLA for 2 reasons. First, the new product does
not seem to be better than EMLA in reducing pain,
and second, neither EMLA nor ELA-Max eliminates
all pain for all children. When new products are
introduced, it is normal to focus on negative feed-
back from users rather than on research-based evi-
dence.
The prevention of pain during medical procedures
is important. Children should have the opportunity,
when possible, to have a local anesthetic applied
before venipuncture and IV insertion. ELA-Max ap-
plied for 30 minutes is as effective as EMLA applied
for 60 minutes in preventing pain. However, neither
anesthetic tested in this study was completely effec-
tive for all children. Children should be told that
local anesthetics can help but may not take away all
of the pain.
ACKNOWLEDGMENTS
This study was supported by a grant from the Children’s
Hospital of Iowa Children’s Miracle Network Research Fund and
grant MO1 RR00059 from the General Clinical Research Centers
Program, National Center for Research Resources, National Insti-
tutes of Health.
We thank Dixie Ecklund, Kathy Eyres, Gail Herzog, Mary Lou
Linder, Donna Rasley, Bridget Zimmerman, and the Clinical Re-
search Center staff for assistance.
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SAME OLD, SAME OLD. . .

“Two-thirds of the drugs approved from 1989 to 2000 were modified versions of
existing drugs or even identical to those already on the market, rather than truly
new medicines, according to a new study.
The report also said that most of the increased spending on new prescription
drugs was on products that the Food and Drug Administration had determined
did not provide significant benefits over those already on the market.“

Petersen M. New medicines seldom contain anything, new study finds. New York Times. May 29, 2002

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 Topical Anesthetics for Intravenous Insertion in Children: A Randomized
Equivalency Study
Charmaine Kleiber, Mark Sorenson, Kathy Whiteside, B. Ann Gronstal and Raymond
Tannous
Pediatrics 2002;110;758
DOI: 10.1542/peds.110.4.758

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 Topical Anesthetics for Intravenous Insertion in Children: A Randomized
Equivalency Study
Charmaine Kleiber, Mark Sorenson, Kathy Whiteside, B. Ann Gronstal and Raymond
Tannous
Pediatrics 2002;110;758
DOI: 10.1542/peds.110.4.758

The online version of this article, along with updated information and services, is
located on the World Wide Web at:
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