Abstracts
participants had higher pain prevalence in two of the studies.
Dental pain, specifically toothache and chewing pain was the
most common type of pain and prevalence estimates ranged
from 12.1% to 42.2%.
(148) Population exposed to the prescription of opioid drugs
(groups N02A and R05DA of the ATC/DDD classification) in the
sanitary region of Lleida (Catalonia, Spain) between 2010 and
2012
J Canal-Sotelo, R Gonzalez-Rubio, J Lopez-Ribes, E Barallat-Gimeno,
N Arraras-Torrelles, and A Martin-Marco; Supportive Palliative Care Team.
Hospital Universitari Arnau de Vilanova., Lleida, Catalonia, Spain
Pain can affect up to 80% of the population. When its intensity is
from moderate to severe is mandatory to prescribe opioid analge-
sics. The objectives of this study are to know the characteristics of
the population exposed to opioids of the second / third analgesic
ladder of the W.H.O. and to calculate the Defined Daily Doses
(DDD) per million of inhabitants for each drug. We designed an
observational and transversal study carried out in the sanitary re-
gion of Lleida. From the database of the pharmacy service we iden-
tify those people who were prescribed the drugs studied
(Anatomical Therapeutic Chemical (ATC) / DDD classification, sub-
groups NO2A and R05DA) over the period 2010 and 2012. The pop-
ulation remained almost stable. In 2010, 16.999 people (4,61%)
and 16.474 in 2.012 (4,47%) were prescribed opioid drugs. In the
three years studied, the group of age between 55-84 years received
consistently >50% of the prescriptions made. Regarding the
gender, the 65% of the population exposed were women
(65,21% in 2010, 64,95% in 2011 and 65,41% in 2012). The
D.D.D. per 106 inhabitants prescribed in the Sanitary Region of
Lleida were 13,3526 (2010), 13,1650 (2011) and 12,9564 (2012). Mi-
nor opioids (tramadol, codeine and dextropropoxifen) accounted
for the 30,5%, 30,4% and 29,5% of the DDD prescribed, respec-
tively. Regarding to the patients exposed to minor opioids, in
2010 6,95 prescriptions for each exposed patients were made,
7,67 in 2011 and 7,80 in 2012. For the patients exposed to strong
opioids, the number of prescriptions made was 9,62 (2010), 9,71
(2011) and 9,37 (2012).
A07 Guidelines, Systematic Reviews, and Meta-analysis
(149) Reporting of cross-over clinical trials of analgesic treat-
ments for neuropathic and musculoskeletal pain: ACTTION sys-
tematic review and recommendations
J Gewandter, A McKeown, M McDermott, K Hoang, I Kataryzyna,
S Kralovic, D Rothstein, I Gilron, N Katz, S Senn, S Smith, D Turk,
and R Dworkin; University of Rochester, Rochester, NY
The cross-over clinical trial design can improve study power by
eliminating between subject variability, which tends to be high
for pain reporting. The goal of this systematic review of chronic
pain cross-over trials was to evaluate the quality of reporting in ar-
ticles published between 1993 and 2013. Of the 124 articles identi-
fied, 76 (61%) reported at least 1 detail regarding blinding,
including 7 trials that included an active placebo to mimic side ef-
fects. Thirty-five (28%) articles reported estimates for baseline and
‘‘post-washout’’ pain scores. Although 116 (94%) articles reported
the number of subjects that completed the trial, only 71 (57%) re-
ported the number that completed the first period. Only 36 (29%)
articles reported a method to accommodate missing data (e.g., last
observation carried forward, n=29), and of those, just 6 analyzed
subjects who provided data from only 1 period. Seventy-six
(61%) articles reported a within-subject primary analysis, or if no
primary analysis was identified, reported at least one within-sub-
ject analysis, which is required to achieve the gain in power associ-
ated with the cross-over design. Seven (6%) articles reported a
between-group primary analysis or if no primary analysis was iden-
tified, only reported between-group analyses. For 39 (31%) arti-
cles, it was unclear whether analyses conducted were within-
subject or between-group. Of the articles that identified a
within-subject primary analysis, 24 (59%) provided sufficient infor-
mation for the results to be included in a meta-analysis (i.e., an es-
timate of the within-subject differences and variability). These
results demonstrate deficiencies in reporting of cross-over trials.
The Journal of Pain S13
Clearer reporting in future trials could maximize readers’ ability
to critically evaluate the results, use these data in meta-analyses,
and plan future trials. In turn, improvement of the execution
and the reporting of cross-over trials could improve the efficiency
of discovering new efficacious and safe analgesic treatments. Sup-
ported by ACTTION public-private partnership.
(150) The relationship between trauma and pediatric chronic
pain: a comprehensive review
S Nelson, S Kashikar-Zuck, and N Cunningham; Cincinnati Children’s
Hospital Medical Center, Cincinnati, OH
Chronic pain conditions are common, with the most prevalent pain
conditions in youth including headaches, abdominal pain, and
musculoskeletal pain. A significant body of research has examined
potential causal or exacerbating factors of these conditions. For
example, a review of the literature suggests that a history of
trauma and/or PTSD (with the inclusion of certain cognitive and/
or neuroendocrine responses) may increase risk for the develop-
ment and/or maintenance of chronic pain in children and adoles-
cents. Evidence also indicates that pain outcomes may vary
depending on type(s) of abuse experienced, with multiple types
of abuse (i.e., complex trauma) during childhood indicative of
greatest impairment. However, the majority of available studies
have solely researched this phenomenon in the context of retro-
spective accounts of abuse in adults. Thus, evidence is still lacking
on the potential relationship between these variables while chil-
dren/adolescents are still young. Drawing from the adult literature,
this review proposes a model that incorporates various factors
(e.g., cognitive, neurological, social, emotional), including the
appraisal process, which may influence vulnerability to or mainte-
nance of pain-related disability in youth who have experienced
trauma. The available literature describing the relationship be-
tween PTSD/trauma and chronic pain, and the potential influence
of associated psychological and/or physiological phenomena in
children and adolescents is also summarized. Recommendations
for medical providers include an assessment of trauma/stress expo-
sure and/or symptoms of PTSD in youth presenting with pain. As-
sessing trauma during routine medical visits and referring
affected youth for appropriate treatment may improve psychoso-
cial and pain-related outcomes in these patients.
(151) Chronic leg ulcer pain – a need for effective topical anal-
gesia
S Parra, P Lacouture, and H Giles; Vapogenix, Inc, Houston, TX
Severe, persistent pain from chronic wounds is common and poorly
treated. Chronic leg ulcers (venous, arterial, diabetic) affect 0.6-3%
of people over 60 years old and for many the worst problem associ-
ated with the ulcer is pain, which is severe in more than 70% of
cases. In addition, many wound care procedures such as debride-
ment and dressing changes exacerbate pain. Current treatments
with systemic analgesics, including opioids, frequently fail to pro-
vide adequate pain control and often result in intolerable adverse
effects. Effective topical analgesia could offer an ideal solution for
chronic wound pain management. However, in the US, there are
no prescription-strength topical analgesics available for use on
wounds. We performed a systematic literature review to identify
clinical trials evaluating the efficacy of topical analgesics for leg ul-
cer pain. PUBMED, MEDLINE, and EBSCO databases were searched
(to October 2015) and revealed 114 publications, of which 20 were
eligible for inclusion in this review. Of these, only 8 were random-
ized, double-blind and placebo controlled. Five studies using
ibuprofen impregnated foam dressing demonstrated some efficacy
on painful leg ulcers (VAS decrease 5-22). Eight studies supported
the use of topical lidocaine plus prilocaine (EMLA) cream for pain
control during wound debridement (VAS decrease 27-65.5). Howev-
er, the slow onset of action could limit its usefulness. While many
other products, including opioids, have been formulated for topical
use and evaluated in leg ulcer pain, their efficacy has not been
consistently superior to control groups. Thus, in the US market, there
is no topical product specifically approved for wound pain manage-
ment, and leg ulcer pain continues to be poorly managed with sys-
temic drugs and off label use of topical agents. Better topical