Pediatric OTCs
Carolyn Whiskin, BScPhm
Disclosure
Honoraria have been received from the following
companies in preparing, reviewing and giving
presentations:
Pfizer
Abbott
Merck
GlaxoSmithKline
Objectives
• To understand the Canadian Paediatric Society
Guidelines regarding cough, cold and fever
• To understand treatment options and supportive
measures for these conditions
• To be able to integrate homeopathic and traditional
medication in pediatrics
The Common Cold
• Young children have lowered immunity
to the more than 100 different cold
viruses
• Not uncommon to get as many as 8–10
colds/yr before age 2
• Fewer colds with age as exposure
increases and immunity develops
• Typical symptoms:
runny/stuffed-up nose, sneezing,
coughing ,headache, mild sore throat,
loss of appetite, fatigue, mild fever
http://www.caringforkids.cps.ca/handouts/colds_in_children
When To Refer
Babies younger than 3 months
• having trouble breathing
• not eating, or if they are vomiting
• have a fever (rectal temperature of 38.5°C or
higher)
When to Refer
Children of all ages
• Breathing rapidly or seem to be
working hard to breathe
• Blue lips
• Coughing causing choking or
vomiting
• Waking with one or both eyes stuck
shut with dried yellow pus
http://www.caringforkids.cps.ca/handouts/colds_in_children
When to Refer
• Much more sleepy than usual,
doesn’t want to feed or play, or is
very fussy and cannot be comforted
• Thick or coloured (yellow, green)
discharge from the nose for more
than 10 to 14 days.
• Any sign of a middle ear infection
(ear pain, drainage from the ear)
http://www.caringforkids.cps.ca/handouts/colds_in_children
Spreading a Cold
Viruses live in the nose, mouth,
eyes and skin and can stay on
surfaces for many hours
Germs can spread whenever we
touch one of these things and
then touch our nose, mouth
or eyes before washing our
hands
http://www.nj.gov/health/flu/documents/module3.pdf
Hand Washing
Hand washing
• 15 to 20 seconds with warm
water and soap for the time it
takes to sing “Happy Birthday”
twice
• Avoid kissing, touching or
holding hands
• Elbow cover cough – droplets
spread several feet
http://www.caringforkids.cps.ca/handouts/colds_in_children
Pertussis Prevention
• Also known as whooping cough
• 25 infant deaths in the USA in 2010 – majority spread from adults
• Adults age 19–65 require a Tdap booster
• Adults over 65 require a booster if they will be in close contact
with an infant
• Pregnant woman not already vaccinated should receive a booster
in the late 2nd semester or 3rd trimester
http://www.adultvaccination.org/whooping_cough_vaccine_pertussis_vaccination_adult_immunization.htm
Cough and Cold
• Health Canada Guidelines
• As of the fall of 2009 all products containing traditional
antihistamines, antitussives, expectorants and decongestants
are to be labelled “Not for use under age 6”
• Why the restriction?
• Lack of evidence for these products in this age group
• Reports of misuse, overdose and adverse effects which include
the following: increased heart rate, convulsions, decreased level
of consciousness, abnormal heart rhythms and hallucinations
Why Restrictions?
• Body weight: children aged 2-6 can weigh the same as
children under age 2 in whom these medications have
not been indicated
• Increased exposure due to higher incidence of coughs
and colds in this age group
• Children less likely to communicate adverse effects
from these medications to caregivers
Standard Treatment
Measures
Health Canada feels that most colds resolve in 6-10 days and that
there is no “cure” for the common cold
Pharmacists can feel comfortable suggesting the following:
• Clear nasal passages and ensure that the child gets enough rest
• Ensure the child gets plenty of clear fluids (e.g., diluted nonsweetened fruit juice, or clear soups)—this prevents
dehydration, reduces congestion and keeps the throat moist
• Provide a comfortable environment with enough humidity
Which Humidifier To
Use?
Humidifiers add moisture to the air, which helps ease coughing and congestion due to a cold
• Safety-Cool mist preferred to avoid burns
• Effectiveness Warm-mist and cool-mist
humidifiers are equally effective. When
water vapor reaches the lower airways,
the temperature is the same. Aim away
from bed and sheets.
• Cost Cool-mist humidifiers are less
expensive than are warm-mist
• Cleaning clean to prevent the growth of
bacteria and molds. Wiping down the
humidifier daily with a 10 percent bleach
solution — 9 parts water to 1 part bleach
— is one way to safely keep it clean
http://www.mayoclinic.com/health/cool-mist-humidifiers/AN01577
Clearing Nasal
Passages
• Suction with rubber bulb
• Squeeze the bulb syringe to expel air
• Insert the tip of the bulb about 1/4 to 1/2 inch
(0.64 to 1.27 centimeters) into baby's nostril,
pointing toward the back and side of the nose
• Release the bulb, holding it in place while it
suctions the mucus
• Remove the syringe and empty the contents
onto a tissue by squeezing the bulb rapidly
while holding the tip down.
• Clean the bulb syringe with soap and water
http://www.mayoclinic.com/health/common-cold-in-babies/DS01106/DSECTION
=lifestyle-and-home-remedies
Nasal Aspiration
• First may use saline solution to dilute
secretions
• Wash device with warm water
• Insert filter
• Insert bulb into nostril while placing
mouthpiece in caregiver’s mouth for
inhalation
• Remove filter and clean device
Saline Solutions
 Benefits of rinsing:
flushes out thickened mucus and irritants,
may help ease swelling in the lining of nasal
passages
 Irrigation solution preparation: dissolve 1/8
teaspoon of table salt into 8 ounces of warm
water
 Commercially available products use sodium
chloride 0.9%; sea salt based products use a
deiozinizing process to bring to isotonic
while leaving natural minerals
Homeopathy:
View of the CPS
• Canadian Paediatric Society reviewed PubMed,
CAM on PubMed, the Cochrane Library and
Health Canada’s websites.
• No trials analyzing the effects of over-the-counter
pediatric homeopathic preparations were found.
• There are only a few good studies showing possible
benefits of homeopathy when prescribed by trained
practitioners for a selected number of specific
conditions in children.
• Therefore, more rigorous studies showing efficacy
need to be completed before it can be recommended
as a credible complementary or alternative therapy
for the pediatric population.
Homeopathy: View of the College of
Family Physicians of Canada
• “It is important to keep in mind that, when used
appropriately, natural health products can be a key part
of a person’s health management.”
• “Consumers can identify a Health Canada authorized
natural health product by the eight-digit Natural
Product Number (NPN) or Drug Identification
Number for Homeopathic Medicine (DIN-4HM) on
the label. These products are also required to have
clear labeling on appropriate use, including dosing, risk
information and whether they can be used safely in
children.”
http://www.cfpc.ca/cough and cold medications frequently asked questions
More Comments
• 1997, by K. Linde et al. (Munich University) published
meta-analysis of 135 clinical trials which compared
homeopathic drugs with a placebo concluded that
"the results of this meta-analysis are not compatible
with the hypothesis that the clinical effects of
homeopathy are completely due to placebo."
1997, by K. Linde et al. (Munich University
Natural Health
Product Options
Coryzalia
• Approved from one month – 6 years of age
• Indications: nasal congestion, runny nose
and sneezing
• Dose: unit dose liquid vial t.i.d. for 5 days
Euphorbium
• Open, multicenter, prospective, active-controlled
cohort study in patients with inflammatory
processes and diseases of the upper respiratory
tract.The primary outcome was to demonstrate
non-inferiority of the homeopathic complex remedy
to xylometazoline.
• Results: comparable efficacy and tolerability profile
of Euphorbium compositum nasal drops SN and
xylometazoline in patients with inflammatory
processes and diseases of the upper respiratory tract
(rhinitis/sinusitis).
http://www.ncbi.nlm.nih.gov/pubmed/15772459
Euphorbium
• In vitro study using virus plaque reduction assays
examined the effect of Euphorbium compositum SN
against pathogens causing various viral infections:
influenza A virus, respiratory syncytial virus (RSV),
human rhinovirus (HRV) and herpes simplex virus
type 1 (HSV-1).
• Euphorbium showed antiviral activity of against RSV
and HSV-1. In addition, an antiviral effect against
influenza A virus and HRV.
http://www.ncbi.nlm.nih.gov/pubmed/11574744
Euphorbium
Dose
• Nasal Spray: Age 2 to 12 years,1 spray into each
nostril 3 times a day
• Oral Drops: Age 2-6, 5 drops 3x/day
Age 6-12, 7 drops 3x/day
• Acute Dosage: May use drops every
60 minutes up
to 12x/d
30-
Natural Health
Products
Viburcol
• Indicated for infants and children for:
teething, pain, colic, infections with or
without fever, sleeplessness and
restlessness
• Dose: Age 0-2, 5 drops 3 x/day
Age 2-6, 8 drops
Age 6-12, 10 drops
Acute – every 30-60 minutes
Suppository: 1 b.i.d. – 0-12 yrs
Acute use every 1-2 hours
Viburcol
Nonrandomized observational study of
38 Belgian centers practising homeopathy and
conventional medicine
Children <12 years old comparable to acetaminophen for
poor eating, cramps, distress, sleep, crying and
temperature
Cough
• An RCT with 139 children (24 to 60
mo) suffering from cough due to upper
respiratory tract infection reported that
2.5 mL of honey before sleep improved
cough frequency and severity, as well as
sleep quality in a mean of 59% of
children
• Honey was significantly superior to no
treatment
or
honey-flavoured DM
cough frequency and severity,
bothersome nature of the cough, and
the child/parent sleep quality, as rated
by the parents
http://www.cps.ca/en/documents/position/treating-cough-cold
Honey in Infants Younger
Than 1 Year
• Only food linked to infant botulism
• Infant botulism is caused by bacteria called
Clostridium botulinum
• If honey is contaminated:
spores
toxins
paralysis
• Bacteria and toxins are odourless, colourless,
tasteless and not destroyed by cooking
Health Canada is advising parents and
caregivers not to feed honey to children
younger than 1 year of age
•
http://www.hc-sc.gc.ca/fn-an/securit/kitchen-cuisine/infant-botul-infantile-eng.php
http://www.hc-sc.gc.ca/fn-an/securit/kitchen-cuisine/infant-botul-infantile-eng.php
Fever
Normal temperature ranges
Method
Normal temperature range
• Rectal
36.6°C to 38°C (97.9°F to 100.4°F)
• Ear
35.8°C to 38°C (96.4°F to 100.4°F)
• Oral
35.5°C to 37.5°C (95.9°F to 99.5°F)
• Axillary
34.7°C to 37.3°C (94.5°F to 99.1°F)
http://www.cps.ca/en/documents/position/temperature-measurement
Measurement
Methods
Summary of recommended temperature measurement techniques
Age
Recommended technique
• Birth to 2 years
1. Rectal (definitive)
Axillary (screening low risk children)
• 2 to 5 years
1. Rectal (definitive)
Axillary, Tympanic (or Temporal Artery if
in hospital) (screening)
• Older than 5 years
1. Oral (definitive)
Axillary, Tympanic (or Temporal Artery if in
hospital) (screening)
2.
2.
2.
• Canadian Task Force on Preventive Health - Strength of Recommendation B, II [39]
http://www.cps.ca/en/documents/position/temperature-measurement
Oral
• Measures temperature of lingual
arteries
• Influenced by food/drink and oral
breathing
• Relies of mouth sealed and tongue
depressed for 3-4 minutes
• Mercury thermometers are no longer
recommended
http://www.cps.ca/en/documents/position/temperature-measurement
Rectal
• Gold standard measurement
• Slower to change based on core
temperature changes
• Affected by insertion depth and stool
presence
• Rectal perforation rare occurance- caution
in neonates (1 in 2 million measurements)
• Cleaning needed to prevent spread of
fecal contaminants
http://www.cps.ca/en/documents/position/temperature-measurement
Axillary
• Inaccurate estimate of core
temperature in children
• Exact placement over axillary
artery required
• Environmental influences
• Suggested as a screening in
neonates by the American
Pediatric Society
Tympanic
• Measures thermal radiation emitted
from the tympanic membrane
• Crying, otitis media and wax do not
affect readings
• Ideal location for core temp.
determination
• Instrument design, depth of insertion
and shape of ear canal can all cause
variations
• Size of device may affect accuracy in
children under 2 years
When to Treat
• Fever is a sign that the body is working to fight
infection – should not be feared
• Fever has a purpose and may resolve viral infections
sooner
• Treatment mainly to provide comfort and reduce
parent anxiety
• Do not wake a sleeping child to give them a fever
reducer
• Hydration and watching behavioural change
emphasized
• No evidence fever reduction reduces morbidity and
mortality or decreases the recurrance of febrile
seizures
When To Refer
• Child with fever is less than 6 months old
• Fever for longer than than 72 hours
• Child is excessively cranky, fussy or irritable
• Child is excessively sleepy, lethargic or does not
respond
• Child is persistently wheezing or coughing
• Fever accompanies rash or any other signs of illness
that are concerning
http://children.webmd.com/news/20110228/new-advice-fighting-fever-children
Treatment Choices
Acetaminophen
• Dose: 10-15 mg/kg per dose q4-6h
• No proof that a loading dose of 30 mg/kg works better
• Onset of Action: 30-60 minutes
• Risk of hepatotoxity with doses over 15mg/kg or at
intervals less than 4 hours
• Combination treatment may offer slight benefit
http://pediatrics.aappublications.org/content/127/3/580/T1.expansion.html
Treatment Choice
Ibuprofen
• Dose: 10mg/kg/ dose every 6-8 hours
• Does not worsen asthma symptoms
• Can cause gastritis, bleeding and ulcers- less common in
acute illness
• Nephrotoxicity – renal insufficiency can develop; concern in
dehydration where prostaglandin synthesis needed for renal
blood flow.- caution in cardiac and renal patients
• Not to be used in infants younger than 6 months
http://pediatrics.aappublications.org/content/127/3/580/T1.expansion.html
American Academy
of Pediatrics
Variable
Acetaminophen
Ibuprofen
• Decline in temperature, °C
1–2
1–2
• Time to onset, h
<1
<1
• Time to peak effect, h
3–4
3–4
• Duration of effect, h
4–6
6–8
• Dose, mg/kg
10–15 every 4 h
• Maximum daily dose, mg/kg
90 mg/kg
40 mg/kg
• Maximum daily adult dose, g/d
4
2.4
• Lower age limit, mo
3
10 every 6 h
6
http://pediatrics.aappublications.org/content/127/3/580/T1.expansion.html
Combination
Treatment
• Studies indicate combination therapy
may be more effective in reducing fever
• May not improve discomfort
• Caution safety of combination
treatment
• Dosage confusion can lead to overdose
• Generally not recommended
http://pediatrics.aappublications.org/content/127/3/580/T1.expansion.html
Fighting the Virus
Oscillococcinum
• RCT showed benefit over placebo in
complete resolution or clear
improvement in 48 hours (48% vs
63%)
• Give one unit dose tube of pellets
every 6 hours for 3 doses at the onset
of symptoms. Ages 2 y and up
(separate from food/toothpaste)
Papp R, Schuback G, Beck E, et al. Oscillococcinum in patients with influenza-like
syndromes: a placebo-controlled, double-blind evaluation. Br Homeopath J 1998;87:69-76
Fighting the Virus
Sambucol
• In an RCT – reduced flu symptoms to
3-4 days; influenza antibodies
increased and TNF-alpha production
increased (44.9 fold)
• Study concluded that, in addition to
its antiviral properties, Sambucol
Elderberry Extract and its
formulations activate the healthy
immune system
http://www.ncbi.nlm.nih.gov/pubmed/11399518;
The effect of Sambucol, a black elderberry-based, natural product, on the
production of human cytokines: I. Inflammatory cytokines
Sambucol
Daily maintenance
Children 1-6 years of age: take 1 teaspoon (5 mL) daily
Children 7-12 years of age: take 2 teaspoons (10 mL) daily
Intensive use
Children 1-6 years of age: take 1-2 teaspoons (5-10 mL) twice
daily
Children 7-12 years of age: take 2-3 teaspoons (10-15 mL)
twice daily
Fighting the Virus
Engystol
• RCT and observational studies show comparable results to
acetaminophen in reducing symptoms and phagocytic activity
improved
• Children (6 to 12 years) 1 tablet 2 times daily. In acute cases, 1
tablet every 1 to 2 hours, up to 8 times a day
• Young children (2 to 6 years) ½ tablet 3 times daily. In acute
cases, 1 tablet every 1 to 2 hours, up to 6 times a day
• Babies (0 to 2 years) ½ tablet 2 times daily. In acute cases, 1 tablet
every 1 to 2 hours, up to 4 times a day
•
Dissolve slowly in the mouth or in a teaspoon of water before
administering to a young child or baby
http://www.homotoxicology.net/Documents/Brochures/Engystol.pdf
Other Options
Echinacea
• 2006 Cochrane review identified 16
controlled trials on the effect of
echinacea for cough—no sufficient data
to suggest the effectiveness of echinacea
in children. The use of echinacea for
eight to 12 weeks as a prophylactic
measure did not result in effective
prevention of the common cold (Source:
CPS)
http://www.cps.ca/en/documents/position/treating-cough-cold
Other Options
Zinc
• Some studies showed benefits, especially if used within
24 h of the onset of common cold symptoms
• Other studies showed no benefit
• At the present time, the use of zinc in children with
cough and cold is not recommended (Source: CPS)
http://www.cps.ca/en/documents/position/treating-cough-cold
Vaccinations
• Use of anti-pyretics before vaccination
may reduce the immune response
• Sugar water preferred to reduce
discomfort before vaccination
• To make sugar water, mix one packet of
sugar (1 teaspoon) with 10 ml of water (2
teaspoons). Administer with a cup, spoon
or syringe just before the needle and discard
the unused portion
http://www.toronto.ca/health/immunization_children/pdf/howtoreducepain.pdf
Making a Difference
Providing information to parents regarding
the care of their sick child is a vital service
pharmacists provide to the community
Take the time to share your knowledge
We all benefit!!