1. Carolyn Whiskin, BScPhm
Pediatric OTCs
Carolyn Whiskin, BScPhm

2. Disclosure
Honoraria have been received from the following companies in preparing, reviewing and giving presentations: Pfizer Abbott Merck GlaxoSmithKline

3. 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

4. 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

5. 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)

6. 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

7. 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)

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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 non- sweetened fruit juice, or clear soups)—this prevents dehydration, reduces congestion and keeps the throat moist
Provide a comfortable environment with enough humidity

14. 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

15. 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
=lifestyle-and-home-remedies

16. 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

17. 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

18. 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.

19. 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.”
and cold medications frequently asked questions

20. 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

21. 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

22. 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).

23. 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.

24. 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 minutes up to 12x/d

25. 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 minutes
Suppository: 1 b.i.d. – 0-12 yrs Acute use every 1-2 hours

26. 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

27. 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

28. 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

29. Fever Normal temperature ranges Method Normal temperature range
Rectal 36.6°C to 38°C (97.9°F to 100.4°F)
Ear °C to 38°C (96.4°F to 100.4°F)
Oral °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)

30. Measurement Methods
Summary of recommended temperature measurement techniques
Age Recommended technique
Birth to 2 years 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)
Canadian Task Force on Preventive Health - Strength of Recommendation B, II [39]

31. 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

32. 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

33. 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

34. 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

35. 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

36. 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

37. 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: minutes
Risk of hepatotoxity with doses over 15mg/kg or at intervals less than 4 hours
Combination treatment may offer slight benefit

38. 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

39. American Academy of Pediatrics
Variable Acetaminophen Ibuprofen
Decline in temperature, °C 1– –2
Time to onset, h < <1
Time to peak effect, h 3– –4
Duration of effect, h 4– –8
Dose, mg/kg –15 every 4 h every 6 h
Maximum daily dose, mg/kg 90 mg/kg mg/kg
Maximum daily adult dose, g/d
Lower age limit, mo

40. 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

41. 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

42. 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
The effect of Sambucol, a black elderberry-based, natural product, on the
production of human cytokines: I. Inflammatory cytokines

43. Sambucol Daily maintenance Intensive use
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

44. 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

45. 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)

46. 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)

47. 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

48. 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!!