Reducing the pain of childhood vaccination: An evidence-based clinical practice guideline

Article (PDF Available)inCanadian Medical Association Journal 182(18):E843-55 · December 2010with107 Reads
DOI: 10.1503/cmaj.101720 · Source: PubMed
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CMAJ
CMAJ•DECEMBER 14, 2010 182(18)
© 2010 Canadian Medical Association or its licensors
1989
I
njections for vaccinations, the most common source of
iatrogenic pain in childhood,
1
are administered at mul -
tiple times to almost all Canadian children throughout
infancy, childhood and adolescence.
2
The pain associated
with such injections is a source of distress for children, their
parents and those administering the injections. If not
addressed, this pain can lead to preprocedural anxiety in the
future, fear of needles and nonadherence with vaccination
schedules.
3
It is estimated that up to 25% of adults have a
fear of needles,
4
with most fears developing in childhood.
5
About 10% of the population avoids vaccination and other
needle procedures because of needle fears.
3
Conversely, minimizing pain during childhood vaccina-
tion can help to prevent distress, development of needle fears
and subsequent health care avoidance behaviours such as
nonadherence with vaccination schedules. More positive
experiences during vaccine injections also maintain and pro-
mote trust in health care providers.
3
In light of the prevalence of pain during vaccine injections
and the potential for substantial adverse sequelae, we iden -
tified a need for a national guidance document to address this
important public health issue. Although the topic was covered
in a previous narrative review
1
and a national guideline,
4
nei-
ther of those documents was based on the requisite systematic
approach and rigorous guideline development process. More-
over, additional data have been published since the appear-
ance of the previous documents.
Our objective was to develop a clinical practice guideline,
based on systematic reviews of the literature, as interpreted
by experts, to assist clinicians in managing procedure-related
pain and distress among children undergoing vaccine injec-
tions. The scope was limited to acute (immediate) pain and
distress at the time of vaccine injection in children 0 to 18
years of age. We did not consider the management of
delayed-onset pain occurring in the hours or days after the
injection. The term “distress” is often used to refer to the
combination of pain and anxiety or fear experienced by chil-
dren before and during painful medical procedures. For the
purposes of this guideline, we considered distress and pain
together, referring to the combination as “pain.”
Methods
We convened an interdisciplinary expert panel, the Help
ELiminate Pain in KIDS (HELPinKIDS) Team, to develop
the guideline. Individual panel members, with the required
expertise in areas of vaccination and immunization, pedi-
atrics, pain, evidence-based medicine, education, knowledge
translation, health policy and guideline development, were
DOI:10.1503/cmaj.092048
Reducing the pain of childhood vaccination: an evidence-
based clinical practice guideline (summary)
Anna Taddio BScPhm PhD, Mary Appleton BA, Robert Bortolussi MD, Christine Chambers PhD,
Vinita Dubey MD, Scott Halperin MD, Anita Hanrahan RN, Moshe Ipp MD, Donna Lockett PhD,
Noni MacDonald MD, Deana Midmer RN EdD, Patricia Mousmanis MD, Valerie Palda MD MSc,
Karen Pielak RN MSc, Rebecca Pillai Riddell PhD, Michael Rieder MD PhD, Jeffrey Scott MD,
Vibhuti Shah MD MSc
Faculty of Pharmacy (Taddio) and Departments of Paediatrics (Ipp), of Family
and Community Medicine (Midmer) and of Health Policy, Management and
Evaluation (Palda, Shah), Faculty of Medicine, University of Toronto, Toronto,
Ont.; Research Institute (Taddio, Ipp, Pillai Riddell) and Department of Psych -
iatry (Pillai Riddell), The Hospital for Sick Children, Toronto, Ont.; Canadian
Center for Vaccinology (Appleton, Halperin, MacDonald, Scott), Halifax, NS;
Departments of Pediatrics (Bortolussi, Halperin, MacDonald, Scott) and of
Psych ology (Chambers), IWK Health Centre, Halifax, NS; Infectious Diseases and
Immunization Committee (Bortolussi) and Drug Therapy and Hazardous Prod-
ucts Committee (Rieder), Canadian Paediatric Society; Departments of Micro-
biology and Immunology (Bortolussi, Halperin), of Pediatrics (MacDonald) and
of Emergency Medicine (Scott), Faculty of Medicine, and Department of Pedi-
atrics/Psychology (Chambers), Faculty of Science, Dalhousie University, Halifax,
NS; Toronto Public Health (Dubey), Toronto, Ont.; Capital Health Region (Han-
rahan), Edmonton, Alta.; National Advisory Committee on Immunization (Han-
rahan); private practice (Lockett), Milton, Ont.; Healthy Child Development
Program (Mousmanis), Ontario College of Family Physicians, Toronto, Ont.;
Department of Medicine (Palda), St. Michaels Hospital, Toronto, Ont.; British
Columbia Centre for Disease Control (Pielak), Vancouver, BC; Department of
Psychology (Pillai Riddell), York University, Toronto, Ont.; Childrens Hospital of
Western Ontario (Rieder), London, Ont.; Department of Medicine (Rieder),
University of Western Ontario, London, Ont.; Department of Paediatrics
(Shah), Mount Sinai Hospital, Toronto, Ont.
CMAJ 2010. DOI:10.1503/cmaj.092048
Key points
Vaccine injections performed in childhood are a
substantial source of distress.
Untreated pain can have long-term consequences,
including preprocedural anxiety, hyperalgesia, needle
fears and avoidance of health care.
Simple, cost-effective, evidence-based pain-relieving
strategies are available.
A “3-P” approach, combining pharmacologic, physical and
psychological factors, improves pain relief.
See also the complete guideline article by Taddio and colleagues at www.cmaj.ca
Previously published at www.cmaj.ca
pain-taddio_Layout 1 24/11/10 10:09 AM Page 1989
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selected from across Canada to represent different perspec-
tives and experiences.
T
he guideline development process was based on published
methods.
6
Details of the methods can be found in the full guide-
line (see Appendix 1, available at www.cmaj.ca /cgi/content /full
/cmaj.092048/DC1). Briefly, we used published literature,
7,8
interviews with key informants and discussions with panel
members and stakeholder partners,
8
including parents,
8,9
to iden-
tify 32 clinical questions for consideration in the guideline. We
subsequently reduced the number of clinical questions to 18, to
reflect the evidence base, as described below.
Pain management is usually based on a “3-P” approach
involving pharmacologic, physical and psychological strat -
egies. Therefore, our evidence base encompassed all of these
domains. For the purposes of this guideline, selected panel
members performed three systematic reviews and meta-analy-
ses, one for each of the three domains of pain manage-
ment.
10
12
We limited the evidence to randomized controlled
trials and studies with quasi-experimental designs. We used
the Cochrane Risk of Bias Tool to determine the quality of
included studies. We critically appraised the evidence and
generated recommendations using the evidence-based meth-
ods outlined by the Canadian Task Force on Preventive
Health Care,
13
including an accompanying level of evidence
and grade for each recommendation (Table 1).
1
4
In total, we evaluated 71 studies that included 8050 chil-
dren. We formulated a recommendation for each clinical ques-
tion according to the strength of the scientific evidence (i.e.,
s
tudy design and methodologic quality), with consideration of
the values that expert reviewers attributed to various outcomes
and parentspreferences. We used a consensus process to
arrive at the final wording for each recommendation.
We circulated the guideline to relevant experts, some of
whom represented stakeholder organizations, for external
review according to the AGREE instrument (Appraisal of
Guidelines for Research and Evaluation; www.agreetrust
.org). In addition, three trained members of the Guidelines
Advisory Committee (www.gacguidelines.ca) who were not
involved in the guideline development process independently
evaluated the guideline. We discussed the comments of all
reviewers and incorporated them into the final manuscript, as
appropriate. We then finalized and approved the guideline.
Funding for this project was provided by the Canadian
Institutes of Health Research. The funding agency had no role
in developing the recommendations, and its views and inter-
ests did not influence the recommendations.
Clinical recommendations
For 14 of the 18 questions, there was sufficient evidence to
make a practice recommendation to reduce pain (Table 2).
These recommendations have been organized into five clus-
ters: infants, injection procedure, parent-
led strategies, pharmacotherapy and
psychological strategies. For the remain-
ing four clinical questions, there was
insufficient evidence to make a practice
recommendation (Table 3).
Several of the practice recommenda-
tions relating to the injection procedure
can be implemented immediately by
health care providers in all vaccination
practice settings, as they do not require
planning or additional resources (e.g,
time, supplies or money). Examples of
these easily adopted pain-relieving
strategies include performing intramus-
cular injections rapidly without prior
aspiration, positioning children upright,
injecting the most painful vaccine last
when multiple vaccines are being admin-
istered and providing tactile stimulation.
Performing intramuscular injections
rapidly without prior aspiration prob ably
reduces pain through the combined
effects of shortening the time of contact
between needle and tissue and reducing
lateral movement of the needle (“wig-
gle) within the tissue. The long-standing
practice of aspiration was initially pro-
posed to reduce the risk of intravascular
injection of the vaccine. However, the
sites commonly used for vaccine injec-
tions are devoid of large blood vessels,
CMAJ•DECEMBER 14, 2010 182(18)
1990
Table 1: Criteria for evaluating evidence and grading recommendations*
Level or grade Criteria
Evidence
I Evidence from randomized controlled trial(s)
II-1
Evidence from controlled trial(s) without
randomization
II-2
Evidence from cohort or casecontrol analytic studies,
preferably from more than one centre or research
group
II-3
Evidence from comparisons between times or places
with or without the intervention; dramatic results in
uncontrolled experiments could be included here
III
Opinions of respected authorities, based on clinical
experience; descriptive studies or reports of expert
committees
Recommendation
A There is good evidence to recommend the action.
B There is fair evidence to recommend the action.
C
The existing evidence is conflicting and does not
allow making a recommendation for or against the
use of the action; however, other factors may
influence decision-making.
D
There is fair evidence to recommend against the
action.
E
There is good evidence to recommend against the
action.
I
There is insufficient evidence (in quantit y or quality
or both) to make a recommendation; however, other
factors may influence decision-making.
*Adapted, with permission , from Palda and colleagues.
1 4
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CMAJ•DECEMBER 14, 2010 182(18)
1991
T
able 2: Recommendations to reduce pain during vaccine injections in children* (part 1 of 2)
Clinical question Recommendation
Level of
evidence
Grade of
recommendation
Infants
Among infants undergoing vaccination,
d
oes breastfeeding during the procedure
reduce pain at the time of injection?
To reduce pain at the time of injection,
e
ncourage breastfeeding mothers to
breastfeed their infants during
v
accination
I
A
Among infants undergoing vaccination,
d
oes administration of sweet-tasting
solutions reduce pain at the time of
injection?
To reduce pain at the time of injection
a
mong infants up to 12 months of age
who cannot be breastfed during
vaccination, administer a sweet-tasting
solution during vaccination
I A
Injection procedure
Among children undergoing vaccination,
does administering one commercial brand
of a vaccine rather than another
commercial brand of the same vaccine
cause less pain at the time of injection?
If more than one commercial brand of a
vaccine is available, and the brands are
interchangeable, inject the least painful
brand during vaccination of children, to
reduce pain at the time of injection
I A
Among children undergoing vaccination,
does positioning the child in a supine
position result in more pain at the time
of injection?
To reduce pain at the time of injection,
do not place children in a supine
position during vaccination
I E
Among children undergoing
intramuscular injection of vaccine, should
slow injection with aspiration be avoided
to reduce pain at the time of injection?
To reduce pain at the time of
injection, administer intramuscular
vaccines to children using a rapid
injection technique without aspiration
I B
Among children receiving multiple
vaccine injections at a single vaccination
visit, does injecting the most painful
vaccine last decrease pain at the time of
injection?
When administering multiple vaccine
injections to children sequentially, inject
the most painful vaccine last to reduce
pain at the time of injection
I B
Among children undergoing vaccination,
does rubbing the skin near the injection
site before and during the procedure
result in less pain at the time of
injection?
To reduce pain at the time of injection
among children aged 4 years, offer to
rub or stroke the skin near the injection
site with moderate intensity before and
during vaccination
II-1 B
Parent-led interventions
Among children undergoing vaccination,
does use of (1) parent-led distraction or
(2) parent coaching result in less pain and
pain-related distress at the time of
injection?
Although there is insufficient evidence
for or against the use of parent-led
distraction or parent coaching during
vaccination of children as a way to
reduce pain at the time of injection,
clinicians may offer this intervention to
parents to reduce pain-related distress
I B
Pharmacotherapy
Among children receiving intramuscular
and subcutaneous injection of vaccines,
does application of topical anesthetics on
the skin before the injection reduce pain
at the time of injection?
To reduce pain at the time of injection,
encourage parents to use topical
anesthetics during vaccination of
children
I A
Psychological interventions
Among children undergoing vaccination,
does use of clinician-led distraction result
in less pain at the time of injection?
To reduce pain at the time of injection,
use clinician-led distraction techniques
during vaccination of children
I B
Among children undergoing vaccination,
does use of child-led distraction result in
less pain at the time of injection?
To reduce pain at the time of injection
among children aged 3 years, use child-
led distraction techniques during
vaccination
I B
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and aspiration is no longer regarded as necessary. About one-
third of vaccinators do not perform aspiration, and there have
been no documented harms caused by omitting this step.
Positioning children upright or holding them during vaccine
injections, rather than laying them supine, reduces pain. Chil-
dren can be seated or held by a parent in a position that is most
comfortable for them (e.g., held in a bear hug or on the parents
lap). Although the exact mechanism underlying the reduction in
pain associated with this positioning is unknown, it may involve
a reduction in anxiety, which in turn reduces the perception of
pain. Conversely, excessive restraint may increase the child’s
distress, so parents and health care providers are encouraged to
hold and support children without using excessive force.
Children routinely receive two or more vaccine injections
during the same visit. Administering the most painful vaccine
last minimizes the priming effect of the first injection on subse-
quent injections, thus reducing overall pain. There is limited
research, however, regarding the optimal order of injection for
vaccines that are coupled for administration at the same visit. At
present, the two vaccines known to be relatively more painful
are M-M-R-II (Merck) and Prevnar (Wyeth). When these are
coupled with other vaccines, they should be given last.
Providing tactile stimulation by rubbing or stroking the skin
near the injection site before and during vaccine injections
reduces pain in children aged four years and older. The pro-
posed mechanism involves blocking the transmission of the
pain sensation to the brain by means of competing touch sensa-
tion. This technique is often referred to as generating “white
noise. The optimal method for rubbing (in terms of frequency,
intensity and pattern) is unknown. It should be tailored to the
request and comfort level of the individual child.
A few practice recommendations in this guideline, such as
breastfeeding or administration of sugar water (for infants)
and application of topical anesthetics and psychological inter-
ventions (for children of all ages), require some planning or
additional resources, or both, on the part of health care
providers and children and their families. Health care
providers are encouraged to discuss these additional options
with parents and children (as appropriate) and to select the
strategies best suited to individual children.
Breastfeeding is considered a combined analgesic interven-
tion because several aspects of breastfeeding (e.g., holding the
child, skin-to-skin contact, the sweet-tasting milk and the act
of sucking) attenuate pain responses. An adequate latch must
be established before the injection. This may take about one
minute. If an adequate latch cannot be established before the
injection or the infant is not being breastfed, sugar water can
be administered instead. The mechanism of action of sugar
water, although not fully elucidated, may involve release of
endogenous opioids through activation of sweet taste receptors
and distraction. Sugar water is easily prepared by mixing a
packet of sugar with 10 mL (two teaspoons) of water and feed-
ing some to the infant a minute or two before the injection.
The infant should be mon itored for minor adverse events such
as choking or gagging.
Topical anesthetics block the transmission of pain signals
from peripheral nociceptors. They are effective for vaccines
that are administered intramuscularly and subcutaneously. At
present, limited evidence indicates that these agents do not
interfere with the immunogenicity of the vaccine. Topical anes-
thetics are available for purchase without a prescription, and
parents have indicated a willingness to pay for them to mitigate
the pain associated with vaccine injection in their children.
However, parents require education about the use of these
agents, including the exact site or sites of administration, the
duration of application and possible adverse effects. Topical
anesthetics must be applied ahead of time, about 2060 min-
utes before the injection, depending on the commercial product
being applied. The topical anesthetic can be applied upon
arrival at the clinic or school (by a parent or a qualified health
care professional or delegate) or before departure from home. If
multiple vaccines are being injected during the same visit, the
topical anesthetic can be applied at two separate sites (e.g.,
right and left legs). The vaccine or vaccines must be injected
CMAJ•DECEMBER 14, 2010 182(18)
1992
Table 2: Recommendations to reduce pain during vaccine injections in children* (part 2 of 2)
C
linical question Recommendation
Level of
e
vidence
Grade of
r
ecommendation
A
mong children undergoing vaccination,
d
oes slow, deep breathing or blowing
performed by the child result in less pain
at the time of injection?
T
o reduce pain at the time of injection,
h
ave children aged 3 years engage in
slow, deep breathing or blowing during
vaccinations
I B
Among children undergoing vaccination,
does use of combined psychological
i
nterventions (i.e., interventions that
i
nclude at least one cognitive and one
behavioural intervention) result in less
pain and distress at the time of injection?
To reduce pain at the time of injection
among children aged 3 years, use
c
ombined psychological interventions
during vaccination
I B
Among children undergoing vaccination,
d
oes suggesting that it wont hurt
result in less pain at the time of injection?
Do not tell children that it wont hurt,
a
s this type of statement, when used
alone, has been shown to be ineffective
in reducing pain at the time of injection
I D
*There is some evidence t hat comb ining strategies i mproves pain relief.
Levels o f evidence and g rades of recommendation ar e defined in Table 1.
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where the anesthetic has been applied. Health care providers
can use a nontoxic marker to outline the area of application.
T
he cost per dose is $5–$10. Transient changes in skin colour
are common. Systemic toxicity is rare but can occur if the dose
or the duration of application is excessive.
Distraction is a psychological intervention that involves
directing the childs attention away from the procedure. Distrac-
tion led by a health care provider is effective for children of all
ages. For children three years of age and older, self-led distrac-
tion is also effective. Distraction led by a parent is less effective,
possibly because the parent has difficulty providing distraction
when he or she is also distressed. The panel recommends, how-
ever, that clinicians discuss parent-led interventions, including
distraction and coaching, on the grounds that some benefits have
been observed in terms of general pain-related distress. In addi-
tion, parents may benefit from a formal role, and there may be
limited availability of other individuals to deliver such interven-
tions. It is important to ensure that age-appropriate distraction
strategies are used and that children are engaged with them.
When appropriate, involve the child in planning which distrac-
tion strategy will be used and in directing the distraction strat-
egy. Examples of distraction strategies include toys (for infants),
bubbles (for toddlers), video games (for school-age children)
and music (for adolescents).
Deep (tummy) breathing is another effective psychological
intervention that can be used for children three years of age
and older. Deep breathing can be facilitated by having the
child blow bubbles or spin pinwheels with the breath. These
a
ids also act as distraction strategies.
Pain relief is enhanced when individual pain-relieving
strategies are combined. Therefore, health care providers are
encouraged to use a mix of strategies to mitigate pain. Parents
can be enlisted to help combine and coordinate many of these
strategies. In particular, parents can prepare their children,
apply topical anesthetics, bring a distraction aid to the appoint-
ment, coach the child during deep breathing and hold the child.
Additional details of the practice recommendations, includ-
ing evidence summaries, references and clinical considera-
tions, can be found in the full guideline (www.cmaj.ca/cgi
/doi/10.1503/cmaj .101720).
Implementation of the guideline
The information contained in this guideline is generalizable to
healthy children undergoing injection of vaccines worldwide.
We offer the following suggestions to assist in implementing
the guideline in various settings.
Context and facilitation
Organizations and health care providers involved in immun -
ization are encouraged to adopt pain management as an inte-
gral component of the vaccination process. Supports should
CMAJ•DECEMBER 14, 2010 182(18)
1993
Table 3: Interventions without sufficient evidence to make a recommendation regarding their use to reduce pain
during vaccine injections in children
Clinical question Recommendation
Level of
evidence*
Grade of
recommendation*
Injection procedure
Among children undergoing vaccination,
does (1) application of a vapocoolant
spray or (2) application of ice or a
cool/cold pack on the skin before injection
of vaccine reduce pain at the time of
injection?
For children undergoing vaccination,
there is insufficient evidence for or
against the use of skin-cooling
techniques (vapocoolants, ice,
cool/cold packs) to reduce pain at the
time of injection
I I
Among children undergoing vaccination,
does simultaneous injection by two
vaccination providers cause less pain at
the time of injection than sequential
injections by the same provider?
For children undergoing vaccination,
there is insufficient evidence for or
against the use of simultaneous
injections rather than sequential
injections to reduce pain at the time
of injection
I I
Route of administration
Among children undergoing vaccination,
for vaccines that can be administered
intramuscularly or subcutaneously, does
administering the vaccines intramuscularly,
rather than subcutaneously, cause less pain
at the time of injection?
For children undergoing vaccination,
there is insufficient evidence to
recommend for or against the use of a
specific route of administration for
vaccines that can be administered
intramuscularly or subcutaneously to
reduce pain at the time of injection
I I
Pharmacotherapy
Among children undergoing vaccination,
does administration of acetaminophen or
ibuprofen before the injection reduce pain
at the time of injection?
For children undergoing vaccination,
there is currently no demonstrated
benefit of administering aceta-
minophen or ibuprofen to reduce pain
at the time of injection
III I
*Levels o f evidence and g rades of recommendation ar e defined in Table 1.
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be put in place to facilitate the implementation of these rec-
ommendations by health care providers.
Required resources
Some costs may be incurred by the incorporation of these recom-
mendations into practice, because of required training of staff,
required time to practise pain management and expenditures to
acquire aids (e.g., bubbles) and resources (e.g., pamph lets for
parents and children). For the most part, these costs are relatively
modest and may be offset by shorter duration of the procedure
(because the child’s distress and struggling are lessened) and
faster recovery time. Many of the practice recommendations are
cost-neutral to parents and the health care system (e.g., rapid
intramuscular injection without aspiration).
Setting for vaccinations
Most of these practice recommendations can be incorporated
in many settings without adding any time to the vaccination
process (e.g., holding infants, tactile stimulation). Pain-reliev-
ing strategies that require additional time (e.g., education and
preparation, application of topical anesthetics) can be imple-
mented ahead of time, either at home or upon arrival at the
vaccination setting, while the child is waiting to be vaccin -
ated. Parents can be asked to pay a nominal fee to cover the
cost of analgesic interventions (e.g., topical anesthetics, bub-
ble solution for blowing, sugar water). Alternatively, anal-
gesic interventions can be provided free of charge.
To date, the guideline has been piloted in an outpatient
clinic setting and a public health vaccination setting at a mid-
dle school. Feedback received suggests that the strategies are
feasible and effective, and that parents and children appreci-
ate efforts made to reduce the children’s pain.
Assessment and documentation of pain
Assessment and documentation of pain during vaccine injec-
tions are important aspects of providing quality care. These
processes allow determination of the effectiveness of analgesic
strategies employed and planning for future vaccine injections.
Adult observers (parents, health care providers or both)
can use validated pain assessment techniques to assess injec-
tion pain in preverbal children and infants. Verbal children
can be asked to self-report their pain using age-appropriate
techniques. Health care providers are encouraged to docu-
ment the strategies used to reduce acute pain at the time of
vaccine injection, as well as the child’s pain score.
Clinical considerations
Some judgment about the suitability and feasibility of the rec-
ommendations is required, as not all of the recommendations
will be appropriate or effective in all situations or for all chil-
dren. In selecting specific pain-relieving strategies for use in a
particular situation, clinicians and parents are advised to con-
sider the analgesic effectiveness of individual modalities, the
goals for the child and the preferences of the child, the parents
and the clinician.
Health care providers should offer pain-relieving options
to parents and children (as appropriate) when they are coun-
selling about other aspects of immunization or well-baby and
child care, as parents and children are largely unaware of
effective pain-relieving strategies.
N
o single pain-relieving strategy recommended in this
guideline has been demonstrated to reliably reduce pain to
zero (i.e., to prevent pain). Clinicians are advised to combine
different pain-relieving strategies, as such combinations
improve pain relief.
12
However, combining pain-relieving
strategies does not ensure pain-free injections.
Tools to support training and implementation
We developed a knowledge translation plan to facilitate dis-
semination and implementation of the guideline. This plan
incorporates several educational tools, including a guide to pain
management for parents and caregivers (Appendix 1, available
at www.cmaj.ca/cgi /content/full /cmaj .092048 /DC1), a guide to
pain management for health care providers (Appendix 2, avail-
able at www.cmaj.ca/cgi /content/full /cmaj .092048/DC1), a tool
that health care providers can use to assess and document pain
(Appendix 3, available at www.cmaj.ca /cgi/content /full
/cmaj.092048/DC1) and a website and educational video for
parents and health care providers (available online and freely
accessible at www.sickkids .ca/Learning/SpotlightOnLearning
/profiles-in-learning/help-eliminate-pain-in-kids/index.html). In
addition, several professional organizations (listed at the end of
the article) have endorsed or supported this guideline and will
assist in its dissemination. This assistance includes online links
to the guideline and associated tools and incorporation of rec-
ommendations in immunization resources. Educational work-
shops are being offered to various stakeholder groups.
The guides for parents and health care providers are similar
and include information about pain-relieving strategies that are
relevant to each user group, as well as information about how
to implement them during vaccine injections. The documenta-
tion tool allows the health care provider to record information
about the vaccine or vaccines administered, the child’s age,
age-appropriate pain assessment techniques and the child’s
pain score. The form can be inserted into the child’s medical
chart and/or given to parents and caregivers. The educational
video demonstrates the use of pain-relieving strategies.
Limitations
The recommendations included in this guideline are limited
by the evidence that was available at the time of publication
of the three systematic reviews.
10–12
Certain recommendations
have more research support than others. In addition, some of
the recommendations are applicable to children of all ages,
whereas others apply only to subgroups of children.
For some pain-relieving strategies (e.g., use of sweet-tasting
solutions, tactile stimulation), the optimal administration
technique and the upper and/or lower age limits for effective-
ness could not be determined with confidence from the exist-
ing evidence.
Some of the research studies upon which the recommenda-
tions are based were limited in terms of the inclusion of chil-
dren and parents with different demographic characteristics
and backgrounds. For instance, children with cognitive impair-
ment or a history of traumatic needle procedures might not
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have been included. The guideline panel did not consider these
factors in the recommendations; however, we acknowledge
t
hat the experience of pain may be mediated by such factors.
Moreover, they may influence the pain-relieving strategies that
clinicians, parents and children choose to employ.
Our literature search did not identify studies examining the
impact on injection-related pain of the environment or setting
in which vaccination was performed (e.g., clinic, school),
characteristics of the needle and selected aspects of the injec-
tion technique (e.g., gauge, length, angle of injection) or the
body region where the vaccine was injected (e.g., arm, thigh).
We recommend that future studies examine the effect of these
factors on pain at the time of vaccine injection.
For this guideline, we did not consider complementary and
alternative medicines, and the published effectiveness of such
therapies could be included in future revisions.
Directions for future research
At present, the optimal pain-relieving regimen for nullifying
pain, rather than simply diminishing pain, is unknown. Addi-
tional research is recommended to determine which pain-
relieving regimens reliably prevent pain in children of differ-
ent ages. New technologies for administering vaccines (e.g.,
microneedles) and needle-free administration techniques
(e.g., nasal sprays) offer alternative ways of preventing pain
for which further investigation is also required.
The impact of consistent pain management during injec-
tion of vaccines on short-term and long-term outcomes,
including the child’s pain, satisfaction with the vaccination
experience, development of needle fears and adherence with
vaccination schedules, has not been evaluated. This is clearly
an important topic for future research.
The education of all primary stakeholders involved in
childhood immunization, including parents, children and
health care providers, is fundamental to any improvements in
the delivery of vaccine injections in children. Additional
research is planned to determine the impact of the knowledge
translation interventions for this guideline.
This article has been peer reviewed.
Competing interests: Anna Taddio has received a clinical trial grant from
Gebauer; has received study drugs for clinical trials from Hawaii Medical,
Ferndale Laboratories and Gebauer; and has received honoraria for meeting
presentations from Wyeth. Moshe Ipp has received unrestricted research
grants from Sanofi and GlaxoSmithKline. He has been a consultant for
Wyeth, Merck, GlaxoSmithKline and Sanofi; has received honor aria from
Novartis, GlaxoSmithKline and Sanofi; and owns stock in Merck and Pfizer.
Donna Lockett and Valerie Palda received consultancy compensation for
their role in the development of these guidelines and the preparation of this
manuscript. Noni MacDonald has received reimbursement for travel
expenses from UNICEF and the World Health Organization related to teach-
ing about vaccine safety. She is also the editor of Paediatrics & Child
Health. Michael Rieder holds a Chair in Paediatric Clinical Pharmacology
sponsored by the Canadian Institutes of Health Research and GlaxoSmith -
Kline. Jeffrey Scott received an honorarium from Sanofi Pasteur for partici-
pation in a session at the 2008 Canadian National Immunization Conference.
Vibhuti Shah has received study drugs for clinical trials from Hawaii Medical
and Ferndale Laboratories. None declared for other authors.
Noni MacDonald is the Section Editor, Population and Public Health
for CMAJ and was not involved in the editorial decision-making process
for this article.
Contributors: Anna Taddio, chair of the HELPinKIDS Team, was the
overall project leader. Anna Taddio, Mary Appleton, Robert Bortolussi,
Christine Chambers, Vinita Dubey, Scott Halperin, Moshe Ipp, Donna
Lockett, Patricia Mousmanis, Michael Rieder and Vibhuti Shah were
responsible for conception of the guideline. Anna Taddio, Christine Cham-
bers and Vibhuti Shah led acquisition of data from the literature, drafted the
clinical questions for consideration in the guideline and led the systematic
reviews and meta-analyses of the literature. All authors participated in refin-
ing the clinical questions, interpreting the data and drafting the recommen-
dations. Anna Taddio wrote the first draft of the manuscript; all authors crit-
ically revised the article for important intellectual content and gave final
approval of the version to be published.
Endorsements: This guideline has been endorsed by the Canadian Center for
Vaccinology, the Canadian Coalition for Immunization Awareness and Pro-
motion, the Canadian Family Practice Nurses Association, the Canadian
Nursing Coalition for Immunization, the Canadian Paediatric Society, the
Canadian Pain Society, the Canadian Pharmacists Association, the Canadian
Psychological Association, and the Community and Hospital Infection Con-
trol Association – Canada.
Acknowledgements: The authors thank the family physicians and pediatri-
cans of the Joint Action Committee on Child and Adolescent Health, the Col-
lege of Family Physicians of Canada and the British Columbia Centre for
Disease Control who provided expert review before submission. See also
Appendix 4, available at www.cmaj.ca /cgi/content /full cmaj.092048/DC1.
Funding: Funding for this project was provided through a knowledge syn-
thesis grant (KRS-91783) awarded by the Canadian Institutes of Health
Research. The views and interests of the funding agency did not influence the
recommendations. Publication of the full guideline was funded by the follow-
ing agencies: Canadian Institutes of Health Research, Canadian Pain Society,
the Linden Fund, BC Ministry of Healthy Living and Sport, Children’s
Health Research Foundation and the Canadian Center for Vaccinology.
REFERENCES
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immunizations: evidence-based review and recommendations. Pediatrics
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2. Immunization schedules: recommendations from the National Advisory Committee
on Immunization (NACI). Ottawa (ON): Public Health Agency of Canada. Avail-
able: www.phac-aspc.gc.ca/im/is-cv/index-eng.php#a (accessed 2009 Jan. 9).
3. Taddio A, Chambers CT, Halperin SA, et al. Inadequate pain management during
childhood immunizations: the nerve of it. Clin Ther 2009;31(Suppl 2):S152-67.
4. Guideline statement: management of procedure-related pain in children and ado-
lescents. J Paediatr Child Health 2006;42(Suppl 1):S1-29.
5. Hamilton JG. Needle phobia: a neglected diagnosis. J Fam Pract 1995;41:169-75.
6. Harris RP, Helfand M, Woolf SH, et al. Current methods of the US Preventive Ser-
vices Task Force: a review of the process. Am J Prev Med 2001;20(3 Suppl):21-35.
7. Taddio A, Manley J, Potash L, et al. Routine immunization practices: use of topical
anesthetics and oral analgesics. Pediatrics 2007;120:e637-43.
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munization; 2008 Jan. 28; Toronto. Toronto (ON): University of Toronto; 2008.
Available: http://resources.cpha.ca/CCIAP/data/700e.pdf (accessed 2009 Jan. 25).
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hood immunization. Paediatr Child Health (Oxford) 2010;15:289-93.
10. Taddio A, Ilersich AL, Ipp M, et al.; HELPinKIDS Team. Physical interventions
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randomized controlled trials. Clin Ther 2009;31(Suppl 2):S48-76.
11. Chambers CT, Taddio A, Uman LS, et al.; HELPinKIDS Team. Psychological
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tions: a systematic review. Clin Ther 2009;31(Suppl 2):S77-103.
12. Shah V, Taddio A, Rieder MJ; HELPinKIDS Team. Effectiveness and tolerability
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routine childhood immunizations: systematic review and meta-analyses. Clin Ther
2009;31(Suppl 2):S104-47.
13. Canadian Task Force on Preventive Health Care. New grades for recommenda-
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14. Palda VA, Guise JM, Wathen CN; Canadian Task Force on Preventive Health
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Correspondence to: Dr. Anna Taddio, Leslie L. Dan Faculty of
Pharmacy, University of Toronto, 144 College St., Toronto ON
M5S 3M2; anna.taddio@utoronto.ca
CMAJ•DECEMBER 14, 2010 182(18)
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    • "Vaccination is one of the most common causes of iatrogenic pain in the paediatric population [54]. This pain is a source of distress for children and their guardians and can lead to pre-procedural anxiety , needle phobia in later life, a mistrust in healthcare providers and healthcare avoidance, including non-adherence with vaccination schedules [55]. While several techniques have been employed with varying success to manage pain during paediatric injections (topical anaesthetic, music distraction, oral distraction in infants, positioning techniques and pH alteration), the ability of microneedles to eliminate pain on injection is a significantly desirable attribute [31]. "
    [Show abstract] [Hide abstract] ABSTRACT: Objective: To examine published research which explores the perception and acceptability of microneedle technology for immunisation and to investigate the suitability of this technology for paediatric use. Methods: A series of keywords and their synonyms were combined in various combinations and permutations using Boolean operators to sequentially search four databases (PubMed, Web of Science, Embase and CINAHL). Following removal of duplications and irrelevant results, 12 research articles were included in the final literature review. Results: The opinions of patients, parents, children and healthcare professionals (HCP) were collated. A positive perception and a high level of acceptability predominated. Conclusion: Microneedle technology research has been focussed on demonstrating efficacy with minimal focus on determining HCP/public perception and acceptability for paediatric use, exemplified by the paucity of studies presented in this review. Commercial viability will depend on HCP/public acceptability of microneedle technology. An effort must be made to identify the barriers to acceptance and to overcome them by increasing awareness and education in stakeholder groups pertaining to the paediatric population.
    Article · Dec 2015
    • "Children may benefit from an evidence-based educational program on general medical procedures that occur quite commonly throughout childhood (e.g., vaccinations, check-ups during well-child visits). The content of such an educational program for children should include (1) procedural information (e.g., how long the procedure will take, who will participate, what tools will be used, and why the procedure is necessary) [5, 6] ; (2) sensorybased information (e.g., physical and emotional sensations children may experience during the procedure, including pain) [6, 10]; and (3) coping strategies such as distraction and deep breathing exercises [11][12][13] . A meta-analysis of information provision research supported the " dual preparation hypothesis, " which states that providing a combination of sensory-and procedure-based information is more effective than either alone [10]. "
    [Show abstract] [Hide abstract] ABSTRACT: . Pediatric medical information provision literature focuses on hospitalization and surgical procedures, but children would also benefit from an educational program regarding more commonly experienced medical procedures (e.g., needles, general check-up). Objective . To determine whether an evidence-based educational program reduced children’s ratings of fear of and expected pain from medical stimuli and increased their knowledge of procedural coping strategies. Methods . An educational, interactive, developmentally appropriate Teddy Bear Clinic Tour was developed and delivered at a veterinary clinic. During this tour, 71 5–10-year-old children ( M a g e = 6.62 years, S D = 1.19 ) were taught about medical equipment, procedures, and coping strategies through modelling and rehearsal. In a single-group, pretest posttest design, participants reported their fear of and expected pain from medical and nonmedical stimuli. Children were also asked to report strategies they would use to cope with procedural fear. Results . Children’s ratings for expected pain during a needle procedure were reduced following the intervention. No significant change occurred in children’s fear of needles. Children reported more intervention-taught coping strategies at Time 2. Conclusions . The results of this study suggest that an evidence-based, interactive educational program can reduce young children’s expectations of needle pain and may help teach them procedural coping strategies.
    Full-text · Article · Sep 2015
    • "c o m / l o c a t e / p a i n PAIN Ò 155 (2014) 1288–1292 According to the Knowledge-to-Action Framework [5] , successful translation of research knowledge is based on development of knowledge tools that are subsequently customized and implemented within the local context. We developed a clinical practice guideline for vaccination pain management with accompanying educational resources, including a fact sheet and video [15]. We subsequently tailored and pilot-tested these resources with new parents [22] . "
    [Show abstract] [Hide abstract] ABSTRACT: Educating parents about ways to minimize pain during routine infant vaccine injections at the point of care may positively impact on pain management practices. The objective of this cluster randomized trial was to determine the impact of educating parents about pain in outpatient pediatric clinics on their use of pain treatments during routine infant vaccinations. Four hospital-based pediatric clinics were randomized to intervention or control groups. Parents of 2- to 4-month-old infants attending the intervention clinics reviewed a pamphlet and a video about vaccination pain management on the day of vaccination, whereas those in the control clinics did not. Parent use of specific pain treatments (breastfeeding, sugar water, topical anesthetics, and/or holding of infants) on the education day and at subsequent routine vaccinations 2 months later was the primary outcome. Altogether, 160 parent-infant dyads (80 per group) participated between November 2012 and February 2014; follow-up data were available for 126 (79%). Demographics did not differ between groups (P > 0.05). On the education day and at follow-up vaccinations, use of pain interventions during vaccinations was higher in the intervention group (80% vs 26% and 68% vs 32%, respectively; P < 0.001 for both analyses). Educating parents about pain management in a hospital outpatient setting leads to higher use of pain interventions during routine infant vaccinations.
    Full-text · Article · Jan 2015
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