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Pain Medicine 2012; *: **–**
Wiley Periodicals, Inc.
5% Lidocaine Medicated Plaster Use in
Children with Neuropathic Pain from
Burn Sequelae
Matias Orellana Silva, MD, Veronica Yañez, MD,
Gabriela Hidalgo, MD, Fernando Valenzuela, MD,
and Rolando Saavedra, MD
Pain Unit, Department of Rehabilitation, COANIQUEM
(Corporation of Aid to Burned Children), Santiago,
Chile
Reprint requests to: Matías Orellana Silva, MD,
COANIQUEM (Corporation of Aid to Burned Children),
San Francisco 8586, Pudahuel, Santiago, RM
9020070, Chile. Tel: 056-2-8734036; Fax:
056-2-6490368; E-mail: morellana@coaniquem.cl.
Data presented, in part, as a poster at the 7th
Congress of the European Federation of IASP
Chapters (EFIC), September 21–24, 2011, Hamburg,
Germany.
Abstract
Objective. Neuropathic pain is a challenge in chil-
dren with burn sequelae. Although relatively infre-
quent, the intensity and chronicity of neuropathic
pain negatively impact functionality and quality
of life. The use of 5% lidocaine medicated plaster
has not previously been reported in children.
We explored the effectiveness and safety of 5%
lidocaine medicated plaster to treat neuropathic
pain in children with burn sequelae.
Design. Three-month prospective, uncontrolled
study.
Setting. Corporation of Aid to Burned Children
(COANIQUEM), a nonprofit pediatric burn rehabilita-
tion center in Chile.
Subjects. Fourteen pediatric patients with burn
sequelae neuropathic pain.
Outcome Measures. Demographics, burn and pain
evolution (type, intensity [using Wong-Baker
FACES], and Douleur Neuropathique 4 [DN4]), and
patient functionality. Plasma lidocaine levels were
measured at 0, 12, 36, and 60 hours after treatment
commencement.
Results. Fourteen patients were evaluable for
plasma lidocaine levels. Twelve patients were avail-
able for clinical assessment (two patients lost to
follow-up) [mean (standard deviation)]: age, 11 years
7 months (2 years 6 months); weight, 45 kg (11.9 kg);
burn evolution, 5 years 6 months (4 years); time
between burn and pain onset, 3 years 6 months
(3 years 2 months); time between pain onset and
treatment, 5.1 months (4.8 months); lidocaine,
between <1/8 and 1/2 plaster; initial pain intensity
(FACES), 6.8 (1.6); final pain intensity, 0 in 11/12
patients; DN4, initial-6, final-2.3. All patients
reported improved functionality. Plasma lidocaine
levels were ⱕ27.45 ng/mL (>180 times below critical
levels). No adverse reactions occurred.
Conclusions. These are the first published data
suggesting that 5% lidocaine medicated plaster
improves patient functionality, and is effective and
safe for the treatment of neuropathic pain in pediat-
ric patients with burn sequelae.
Key Words. 5% Lidocaine Medicated Plaster; Neu-
ropathic Pain; Burn Sequelae; Pediatric
Introduction
Burns represent a common and potentially devastating
cause of injury and distress in children, most commonly as
a result of thermal injury (scalds, contact, flame) [1–3].
Furthermore, burns are a major source of pediatric mor-
bidity and are associated with significant annual health
care resource utilization; U.S. data show that approxi-
mately 10,000 children (aged <18 years) were hospitalized
with burn-associated injuries in 2000, with related health
care costs of >USD 200 million [4]. Over recent decades in
Chile, there has been a decrease in the burn rate; in 1993,
the rate was 3,000/100,000 in children aged <15 years,
and a 2001 study records a rate of 933/100,000 in the
same population. Of this group, about 15% of patients
require surgery and/or rehabilitation programs due to the
severity of their burns; this equates to about 6,000 per
year who require rehabilitation [5].
Pediatric patients with burn sequelae pose multiple chal-
lenges, among which the presence of chronic pain, and
neuropathic pain is a problem that is often underdiagnosed
1
Orellana Silva et al.
and undertreated [6–8]. Importantly, regardless of the
cause or extent of the burn injury, all children with burns will
experience pain [8]. The intensity and chronic nature of the
pain have an adverse effect on functionality and quality of
life of patients and their families, and are associated with
the onset of depression, a negative impact on psychomo-
tor development, limited participation in everyday activities,
and social exclusion—factors that are fundamentally
important for every human being [8–11].
Pediatric burn pain management often focuses only on
acute and procedural pain, such as that related to dress-
ing changes, physiotherapy, or postoperative procedures
[12]; the management of neuropathic burn pain is often
overlooked. Moreover, pharmacological management
strategies for neuropathic pain in children rely largely on
the use of anticonvulsants, antidepressants, and clonidine
[8]. From the pathophysiological perspective, such phar-
macotherapy is unsuitable for use in neuropathic pain
associated with burn sequelae, as this is localized neuro-
pathic pain in which membrane stabilization with these
drugs does not involve the peripheral membrane channels
that are mainly associated with this kind of pain. Moreover,
these drugs act systemically, with frequent adverse
effects, contraindications, and variable clinical results, with
no evidence of efficacy in long-term treatment, exceeding
the target of controlling localized neuropathic pain.
In adults, the use of 5% lidocaine medicated plaster has
been shown, in numerous clinical studies, to be effective
in localized neuropathic pain of varied etiology, including
painful postherpetic neuralgia, diabetic neuropathy,
surgical and nonsurgical trauma, low back pain with
neuropathic components, and burns [13–21]. To our
knowledge, there is only one previous report on the use of
5% lidocaine plaster in adolescents with neuropathic scar
pain, not due to burns, and the previous report does not
present safety information [22].
The aim of this study was to validate the 5% lidocaine
medicated plaster as a safe and effective treatment for
neuropathic pain in children with burn sequelae and its
effect on functionality. To the authors’ knowledge, this is
the first report of the use of the 5% lidocaine medicated
plaster for neuropathic pain in children with burn sequelae.
Materials and Methods
This was a 3-month prospective, uncontrolled clinical trial
conducted at the Corporation of Aid to Burned Children
(COANIQUEM), Santiago, Chile. COANIQUEM (http://
www.coaniquem.cl/) is a nonprofit pediatric burn rehabili-
tation center, which is a reference center for both the
acute and rehabilitation management of burned children
in Chile.
Inclusion criteria were as follows: males and females aged
>6 years of age; bodyweight >20 kg; scar or graft with
no open wounds, completely re-epithelialized; localized
neuropathic pain in postburn scar or graft; and signed
informed consent approved by the ethics committee.
2
Patients were excluded from the study if there was a
history of psychiatric disorders, or if peripheral nerve injury
was present (in order to isolate localized neuropathic
pain from burn scars from other possible neuropathic
pain conditions).
Clinical variables and plasma lidocaine concentrations
were measured. Use of the 5% lidocaine medicated
plaster was as recommended by the supplier: the plaster
was applied for 12 hours, followed by 12 hours with no
plaster, and this cycle was repeated until 3 months of
observation had been completed. Each 10 cm ¥ 14 cm
plaster contains 700 mg (5% w/w) lidocaine. No other
type of medicinal product (related to pain management or
any other condition) was administered during the 3-month
observation period.
Clinical variables assessed were as follows: patient
demographics (age, weight, gender), details of the
burn (type of management following injury, time
since the burn occurred and onset of pain), the nature of
the pain (type, intensity [assessed using the FACES], and
Douleur Neuropathique 4 [DN4] pain rating scales), and
the patient’s functionality based on an open-ended
question about the greatest pain-related limitation
to daily activities. Patients were asked about adv-
erse reactions at all visits, and the author recorded
all information.
The Wong-Baker FACES Pain Scale is a validated
pediatric-rating tool [23–25] consists of an illustrative
series of five color faces that depict increasing pain inten-
sity on a 0–10 scale in increments of 2. The end points of
the scale were explained as “no pain” and “very much
pain”. Each child was asked to point to the face that best
represented his/her current pain. The DN4 questionnaire,
a clinician-administered assessment tool that identifies
neuropathic pain characteristics, was developed and
validated recently in France [26].
The medicated plaster was applied to the area of pain for
12 hours, and then removed to leave the next 12 hours
without plaster. Plasma lidocaine levels were measured
before application of the 5% lidocaine medicated plaster,
and 12, 36, and 60 hours after application, using chro-
matography with detection by mass spectrometry.
No statistical analysis was performed as this was a
descriptive, uncontrolled clinical study.
Results
Fourteen patients were enrolled in the study in accor-
dance with the inclusion and exclusion criteria. Clinical
evaluation was incomplete for two patients because they
failed (for unknown reasons) to attend checkups and
could not be traced using the supplied contact details.
Results are presented from serial plasma measure-
ments in all 14 patients and full clinical follow-up in
12 patients (Table 1).
 Table 1 Individual data for 12 patients who were available for full clinical assessment

Initial
FACES/ Lidocaine Plaster Dose; FACES/
Weight Type and Extent Duration Since DN4 Maximum Plasma DN4 after Adverse
Patient Gender/Age (kg) of Original Burn Original Burn Scores Concentration (ng/mL)* 3 Months Effects Comments

1 F, 11 years 7 months 45.5 Left arm, grafted 3 years 11 months F8/D4 1/7 plaster; 2.77 0/0 None No comments
(36 hours)
2 M, 10 years 6 months 43 Left arm, grafted 6 years 3 months F5/D5 1/6 plaster; 20.25 0/1 None Improved movement
(60 hours)
3 F, 15 years 8 months 46 Left foot, no graft 1 months F8/D5 <1/8 plaster; <0.5† 0/6 None After 5 months, new pain
(60 hours) in the location,
associated with
dysmenorrhea
1
4 F, 10 years 6 months 53.5 Thorax, no graft 9 years F6/D6 /8 plaster; 14.20 0/0 None No comments
(12 hours)
1
5 F, 11 years 5 months 63 Left arm, grafted 10 years 5 months F8/D6 /8 plaster; 27.45 0/4 None Worst symptom:
(12 hours) intolerance to sunlight;
no symptoms after
3 months
1
6 M, 10 years 31.5 Right leg, grafted 6 years 9 months F6/D5 /2 plaster; 13.75 0/0 None After 3 months, the
(36 hours) patient and his mother
were able to touch the
leg, improving graft
care, dressing, and
playing
1
7 F, 8 years 1 month 25 Right foot, no graft 11 months F4/D6 /8 plaster; 1.16 0/0 None After 3 months was able
(60 hours) to wear shoes
1
8 F, 10 years 11 months 42 Left leg, grafted 1 year 8 months F6/D6 /8 plaster; 3.09 0/3 None Improved sleep quality
(60 hours)
9 F, 16 years 2 months 52.5 Left hand, grafted 3 months F9/D7 <1/8 plaster; 20.05 0/2 None Able to touch items with
(36 hours) hand
10 M, 9 years 27.5 Left foot, no graft 6 years 7 months F10/D8 <1/8 plaster; 4.24 2/2 None Rapid decrease in area
(36 hours) of pain, able to play
football
1
11 M, 11 years 7 months 40 Left leg, grafted 1 year 11 months F6/D5 /4 plaster; 6.41 0/0 None Able to run and jump
(60 hours)
1
12 F, 15 years 3 months 55 Left foot, no graft 8 months F8/D6 /8 plaster; 1.45 0/4 None Rapid decrease in area
(60 hours) of pain

* Two patients lost to follow-up for clinical assessment had maximum plasma lidocaine concentrations (both at 36 hours) of 1.36 ng/mL and 8.20 ng/mL, respectively.
†
Patient placed the plaster on the foot (foot pain).

3
Lidocaine Plaster in Pediatric Burn Sequelae Neuropathic Pain
Orellana Silva et al.
Figure 1 Evolution of pain intensity over 3 months. Mean FACES Pain Scale scores for 12 evaluable patients.
The 12 patients consisted of eight females and four males.
The mean age was 11 years 7 months (standard deviation
[SD]: 2 years 6 months; range: 8 years 1 month–16 years
2 months) (Table 1), and the mean weight was 44.9 kg
(SD: 12.4 kg; range: 25–63 kg). The original burn injury
had occurred at an average age of 6 years 4 months (SD:
5 years 6 months). The site of injury was the lower limbs in
seven cases (the foot [four cases]), the upper limbs in four
cases (the hand [one case]), and the thorax in one case.
Seven of the 12 patients had received a graft (Table 1).
The time between the initial injury and the onset of pain
was 3 years 6 months (SD: 3 years 2 months; range: 1
month–10 years 5 months), and the time between the
onset of pain and the start of treatment was 5.1 months
(SD: 4.8 months). The mean initial score was 7.0 (SD:
1.8) on the FACES scale, with a median of 6 by DN4.
Fractions ranging from <1/8 to 1/2 of a lidocaine plaster
(distribution shown in Table 1) were used to cover the
painful area completely.
Mean FACES scale scores decreased progressively over
time (Figure 1). At the end of the third month of treatment,
all but one patient had a FACES score of 0; the exception
had a FACES score of 2 (Table 1). With regard to the DN4,
values also decreased to a median of 2 by the end of
the third month.
Based on an open-ended question about the greatest
pain-related limitation to daily activities, all patients
reported improved functionality (Table 1). Improvements
included increased sleep quality, ability to touch the origi-
nally affected burn area, increased mobility/activity (e.g.,
able to run and jump, play football), and rapidly decreased
pain in the area of the original burn.
As presented in Table 1 and Figure 2, the analysis of
plasma samples from the 14 children showed a maximum
lidocaine concentration of 27.45 ng/mL. In nine patients,
maximum plasma samples did not exceed 10 ng/mL.
4
There was no detectable correlation between the size of
the plaster applied and the plasma concentration.
No adverse reactions were recorded following the appli-
cation of the 5% lidocaine medicated plaster.
Discussion
The 5% lidocaine medicated plaster is efficacious in the
neuropathic pain of varied etiology, such as painful dia-
betic neuropathy, postherpetic neuralgia, surgical and
nonsurgical trauma, and low back pain with neuropathic
components [13–21]. However, all current clinical trials
have been conducted in adults, and there is currently a
lack of safety and efficacy data in pediatric patients.
Patients with burn sequelae experience chronic pain with
neuropathic characteristics, although the exact frequency
of neuropathic-like pain and associated symptoms after
burn injury varies widely [27]. The incidence of paraes-
thetic sensations has been reported in up to 82% of adult
patients 1 year or more after burn injury [28]; other inves-
tigators report incidence rates for burn-associated chronic
pain in adults of 36% [29] and 52% [30]. These estimates
are probably biased because they involve referral centers
that attract patients with complications, and surveys that
are likely to be answered by patients experiencing pain.
Patients with chronic pain have a higher prevalence of
other associated conditions and reduced functionality,
which limits their ability to cope independently. In the case
of children, this entails an alteration to normal psychomo-
tor development and learning ability. There are currently no
data on the frequency of chronic and/or neuropathic pain
in pediatric patients with burn sequelae. There is only one
published report about the use of 5% lidocaine medicated
plaster in adolescents, with scars not due to burns. This
report shows good clinical results, but there is a lack of
information regarding lidocaine plasma levels and safety
data [22]. At our center, unpublished studies with repre-
sentative samples have found the frequency to be 7% for
 Lidocaine Plaster in Pediatric Burn Sequelae Neuropathic Pain
30
25
20
15
Figure 2 Mean plasma lido-
10
caine concentrations (ng/mL) up
to 60 hours after application of
5
5% lidocaine medicated plaster.
The solid bars represent the
0
mean application time for each 0 12 hrs.
plaster; the solid arrows indicate
plasma sampling times.
superficial burns and 18% for deep burns requiring grafts
or progressing to hypertrophic scarring.
The absence of a pathophysiologically suitable treatment
option for neuropathic pain from burn sequelae led us to
evaluate the safety and efficacy of the 5% lidocaine medi-
cated plaster in our patients with neuropathic pain in
scars, as these represent a paradigm of localized periph-
eral neuropathic pain.
Patients aged >6 years were selected because, in our
experience, pain assessment is less reliable in patients
aged younger than 6 years of age. There is no universally
accepted method for evaluating the intensity and charac-
teristics of neuropathic pain in pediatric patients. However,
our clinical experience suggests that using the validated
Wong-Baker FACES scale is reliable, mainly for sensitivity
to therapy-induced changes, and the DN4 is easily under-
stood by patients and their parents. Moreover, pediatric
patients prefer the FACES scale to a numeric one [31].
Patients with psychiatric or emotional problems likely to
become chronic pain sufferers were excluded, as this
clinical phenomenon was beyond the scope of our study,
which focused on neuropathic local pain.
Clinical follow-up was completed in 12 of the 14
patients, whereas two patients were lost to follow-up. All
12 evaluable patients had deep injuries, but only seven
had received grafts (the other three patients had not
received grafts due to incorrect initial assessment). It
should be noted that these patients were referred to our
center after the acute phase, so their detailed past
history was unavailable.
The time of onset of pain after injury varied widely. In some
cases, pain developed within the first 4 months, whereas in
another case it took more than 10 years; nevertheless, this
did not influence the Wong-Baker FACES score or the
clinical outcome. Therefore, we believe that, regardless of
24 hrs. 36 hrs. 48 hrs. 60 hrs.
the time period from initial burn injury to pain onset, tackling
neuropathic pain (as determined by clinical features) is the
correct approach and the appropriate way to care for
patients. According to our observations, a phenomenon
exists whereby pain treated successfully may recur. In fact,
one patient in this current case series suffered a recurrence
of pain 2 months after treatment ended (with a FACES
score of 0); the recurrent pain was associated with dys-
menorrhea. Due to the recurrence of pain, this patient
underwent psychological tests, which proved normal (Ror-
schach and Luscher test). In other patients with neuro-
pathic pain not belonging to this case series, we have
recorded pain recurrence in association with appendicitis,
sprained ankle (unrelated to the scar site), direct sun expo-
sure, and pregnancy. We believe this phenomenon repre-
sents a neurological alteration (due to a change in
membrane channel expression and/or a change in spinal
modulation) that determines susceptibility to pain in
response to insults that bear no direct relationship. We
suspect that this may be the mechanism of the observed
pain reduction effect of the 5% lidocaine medicated plaster,
as this drug directly counters this hypothetical mechanism.
The time between pain onset and starting treatment also
varied widely, although it was not comparable with the
time of pain onset. In fact, the time course of pain reduc-
tion showed no difference between patients with longer
and shorter latent periods.
The plaster was applied as recommended by the manu-
facturer, being divided into fractions according to the size
of the painful area. The highest lidocaine plaster dose
used (half a plaster per application) was in a male patient
aged 10 years and weighing 31.5 kg. The maximum
plasma lidocaine concentration recorded in this patient
was <14 ng/mL. The next highest lidocaine plaster dose
(one quarter of a plaster) and patient’s weight (40 kg) was
also in a male (aged 11 years 7 months), with a maximum
plasma lidocaine concentration of 6.41 ng/mL (Table 1).
5
Orellana Silva et al.
Pain intensity decreased rapidly. After the first week of
application, the mean FACES score had halved. Seven
patients had a FACES score of 0 after 1 month, while by
the second and third months the corresponding numbers
of patients scoring 0 on the FACES scale were 8 and 11,
respectively. One patient still scored 2 on the FACES scale
at the end of the third month, but this decreased to a
FACES score of 0 after the study period had ended. As the
plasma lidocaine level in this patient was below the detect-
able limit (<0.5 ng/mL), we believe that this was probably
because the pain was in the sole of the foot, where the
skin is thicker.
DN4 scores also reduced progressively during the
3-month study period. It should be noted that, generally in
patients with burn sequelae and scars, pruritus, one of the
components of DN4, is common (over 80% depending on
the stage to which the scar has progressed). In some
cases beyond this study, pruritus corresponds to the
inflammatory activity triggered by recent scars, but in
other cases it occurs when the scar shows no inflamma-
tory activity, proves refractory to standard pharmacologi-
cal and nonpharmacological management, and appears
quite some time after the original injury, as with pain. We
believe that, in these cases, chronic pruritus has neuro-
pathic features, and we have preliminary unpublished
experience of using the 5% lidocaine medicated plaster
with good results. Nevertheless, we have not observed
any adverse effect, including pruritus, during the utilization
of lidocaine plaster in this study.
It is well accepted that patient functionality and quality of
life are adversely affected by the intensity and chronic
nature of pain resulting from burn injury, resulting in limited
participation in everyday activities, social exclusion, and
increased rates of depression [8,9]. In a final assessment
for patients, their families, and clinicians, these factors
must represent the most important concerns of any
involved in burn management programs. After 3 months of
treatment with the 5% lidocaine medicated plaster, all
patients in our study reported improvements in terms of
functionality; patients experienced rapidly decreased pain
in the area of the original burn, improved mobility/activity,
the ability to touch the originally affected burn area,
improved sleep quality, and a return to their normal lif-
estyles. There are many instruments for rating functional-
ity, both generic and specifically for burns patients and
pain sufferers; we used an open-ended question about
the greatest pain-related limitation or inconvenience to
daily activities, and how this evolved with treatment. This
approach is more widely applicable clinically and is con-
sidered important by patients.
Plasma analysis showed that the highest lidocaine con-
centration was 27.45 ng/mL, in the 12-hour sample from
a female patient with a painful area located in the arm. All
plasma lidocaine concentrations were well below concen-
trations reported to be associated with arrhythmias or
systemic toxic effects. Concentrations were also much
lower than those achieved with other topical lidocaine
formulations (such as eutectic mixture of lidocaine and
6
prilocaine [EMLA]). The absence of systemic and local
adverse effects (not even pruritus at the plaster application
site) suggests that the 5% lidocaine medicated plaster
may be a safe option for pain relief in the target population,
although much larger studies are needed to establish
safety. Nevertheless, it is important for clinicians to be alert
to any potential future complications in the adult popula-
tion in order to extrapolate this hypothetical situation to the
pediatric population.
Conclusions
The 5% lidocaine medicated plaster appears to be safe
and effective for use in patients aged >8 years with neu-
ropathic pain characteristics resulting from burn injuries; to
date, it is the only option for local therapy without using
systemic drugs. Future studies, comparing the 5%
lidocaine medicated plaster with placebo and conven-
tional drugs, are required in order to further confirm its
effectiveness and safety in children.
Acknowledgments
The authors thank David P. Figgitt, PhD, Content Ed Net,
for providing valuable editorial assistance in the prepara-
tion of the manuscript. Editorial assistance was funded by
Grünenthal GmbH, Aachen, Germany. The authors also
thank Dr. Cristina Gastó, Grünenthal Chilena Ltda., and Dr.
Ingrid Tacken, Grünenthal GmbH, Aachen, Germany, for
study medication supply and scientific discussion.
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