Tài liệu Review of essential medicine priorities in ear, nose and throat conditions in children doc

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Gray ENT priorities draft 2 - 5 -
The Integrated Management of Childhood Illness (IMCI) handbook (updated in 2005)
was also reviewed.
4
Recommendations for the child presenting with a acute ear
infections, “runny nose”, and “sore throat and cough” were identified.In the latter
case, the advice is as follows: “To soothe the throat or relieve a cough, use a safe
remedy. Such remedies can be homemade, given at the clinic, or bought at a
pharmacy. It is important that they are safe. Home-made remedies are as effective as
those bought in a store” However, a few warnings are also given: “Harmful remedies
may be used in your area. … Never use remedies that contain harmful ingredients,
such as atropine, codeine or codeine derivatives, or alcohol. These items may sedate
the child. They may interfere with the child’s feeding. They may also interfere with
the child’s ability to cough up secretions from the lungs. Medicated nose drops (that
is, nose drops that contain anything other than salt) should also not be used.” For the
diagnosis “NO PNEUMONIA: COUGH OR COLD”, the advice is that such a child
“does not need an antibiotic. The antibiotic will not relieve the child’s symptoms. It
will not prevent the cold from developing into pneumonia. Instead, give the mother
advice about good home care. A child with a cold normally improves in one to two
weeks. However, a child who has a chronic cough (a cough lasting more than 30 days)
may have tuberculosis, asthma, whooping cough or another problem.”

In addition, the Technical updates of the guidelines on the IMCI from 2005 included a
review of the management of acute and chronic ear infections.
5


The following list of priority conditions (or groups of conditions) was thus used:
• Acute croup
• Epiglottitis
• Epistaxis
• Otitis externa
• Otitis media (acute and chronic)
• Rhinosinusitis
• Sore throat

Gray ENT priorities draft 2 - 6 -
3. Search for suitable guidelines

The following sources were searched in order to identify suitable evidence-based
treatment guidelines:

• National Institute for Health and Clinical Excellence (http://www.nice.org.uk/)
• Scottish Intercollegiate Guidelines Network (http://www.sign.ac.uk/)
• National Guideline Clearinghouse (http://www.guideline.gov/)
• Agency for Healthcare Research and Quality (http://www.ahrq.gov/)
• Bandolier (http://www.jr2.ox.ac.uk/bandolier/booth/booths/ent.html)
• Canadian Paediatric Society (http://www.cps.ca/english/index.htm)
• American Academy of Pediatrics (http://www.aap.org/)
• The Royal Children’s Hospital, Melbourne (http://www.rch.org.au/)

In addition, the clinical query facility of PubMed (Medline) was used to identify
suitable systematic reviews (including Cochrane Reviews) in relation to the priority
conditions chosen. The contents of the International Journal of Pediatric
Otorhinolaryngology were also searched.

Gray ENT priorities draft 2 - 7 -
4. Identified guidelines

4.1 Acute croup
The Royal Children’s Hospital has a guideline on the management of acute croup
6

The Main differential diagnoses are listed as epiglottitis, bacterial tracheitis and
laryngeal foreign body. The flowchart for management is as shown

Gray ENT priorities draft 2 - 8 -
The specific medications listed are nebulised adrenaline, prednisolone 1mg/kg orally
and dexamethasone 0.6mg/kg IM. The Monash University web site provides similar
advice, but with no evidence referenced for the specific details on steroid dosing
(http://www.med.monash.edu.au/paediatrics/resources/uao.html#croup).

The South African STG/EDL for PHC also lists the following specific treatment:
• paracetamol, oral, 4–6 hourly, when required to a maximum of four doses
daily.
• “If the child requires referral - while awaiting transfer:
o adrenaline,1:1000, nebulised, immediately using a nebuliser. If there is
no improvement, repeat every 15 minutes, until the child is
transferred. Dilute 1 mL of 1:1000 adrenaline with 1 mL sodium
chloride 0.9%. nebulise the entire volume with oxygen at a flow rate
of 6-8 L/minute
o prednisone, oral, 2 mg/kg, single dose”.
4.2 Epiglottitis

The South African STG/EDL only provides advice for antibiotic therapy in acute
epiglottitis in children, as follows: cefotaxime, IV, 50 mg/kg/dose, 8 hourly for 7 days
(or, in cases of penicillin allergy - chloramphenicol, IV, 25 mg/kg/dose, 6 hourly for 7
days).

The American Academy of Pediatrics provides guidance on the referral for surgical
management (“The following patients are preferably managed by a pediatric
otolaryngologist: Infants and children with complicated infections that may require
surgery involving the ear (eg, otitis media with effusion and hearing change), the nose
and paranasal sinuses (eg, chronic rhinosinusitis), the pharynx (eg, recurrent
adenotonsillitis), the airway (eg, epiglottitis), and the neck (eg, retropharyngeal
abscess).
7

4.3 Epistaxis

The Royal Children’s Hospital has a guideline on the management of epistaxis.
8
Some
medications are mentioned:
• petroleum gel, if dry cracked mucosa are found to be a contributing factor
• vasoconstrictors applied via spray or cotton wool to Little's area, for persistent
bleeding (the example cited being a branded product – Co-phenylcaine forte®,
which contains lignocaine hydrochloride 50mg/ml and phenylephrine
hydrochloride 5mg/ml in a aqueous spray formulation –
http://www.enttech.com.au/downloads/Co-
Phenylcaine%20Product%20Information.pdf)

The South African STG/EDL suggests an alternative vasoconstrictor, as follows:
oxymetazoline 0.025%, nose drops, 1–2 drops instilled into the affected nostril(s) and
repeat digital pressure as above. No evidence for the efficacy of this measure is,
however, provided.

A Cochrane Review has covered the issue of recurrent epistaxis in children.
9
Three
studies were retrieved, involving a total of 256 participants. One randomised
Gray ENT priorities draft 2 - 9 -
controlled trial (RCT) compared Naseptin® antiseptic cream (containing
chlorhexidine hydrochloride 1mg and neomycin sulphate 3250IU/g) with no
treatment. Another RCT compared petroleum jelly with no treatment and a controlled
clinical trial compared Naseptin® antiseptic cream with silver nitrate cautery. The
authors found that: “Overall, results were inconclusive, with no statistically
significant difference found between the compared treatments. No serious adverse
effects were reported from any of the interventions, although children receiving silver
nitrate cautery reported that it was a painful experience (despite the use of local
anaesthetic)”. They concluded: “The optimal management of children with recurrent
idiopathic epistaxis is unknown. High quality randomised controlled trials comparing
interventions either with placebo or no treatment, and with a follow-up period of at
least a year, are needed to assess the relative merits of the various treatments currently
in use”.
The question of “cautery or cream” had also been addressed in a previous short
review article.
10
On the basis of two papers, the authors concluded that: “Cautery and
naseptin are equally effective. Given the ease of application naseptin is the
treatment of choice.”
4.4 Otitis externa

The South African STG/EDL suggests the use of acetic acid 2% in alcohol, instilled
3–4 drops 4 times daily into the cleaned and dried ear.

Evidence-based guidelines were published by American Academy of Otolaryngology-
-Head and Neck Surgery Foundation in 2006.
11,
The recommended flowchart for
management of acute otitis externa is as shown below.

Gray ENT priorities draft 2 - 10 -


The review noted that available topical preparations contained an antibiotic (an
aminoglycoside, polymyxin B, a quinolone, or a combination of these agents), a
steroid (such as hydrocortisone or dexamethasone) or a low pH antiseptic (such as
aluminum acetate solution or acetic acid). The authors “found no significant
differences in clinical outcomes … for antiseptic vs antimicrobial, quinolone
antibiotic vs nonquinolone antibiotic(s), or steroid-antimicrobial vs antimicrobial
alone” They stated that “[r]egardless of topical agent used, about 65% to 90% of
patients had clinical resolution within 7 to 10 days”. A specific systematic review of
the role of antimicrobials was published in the same supplement.
12
It provided the
detailed evidence for the stance that “Topical antimicrobial is highly effective for
acute otitis externa with clinical cure rates of 65% to 80% within 10 days of therapy.
Minor differences were noted in comparative efficacy, but broad confidence limits
containing small effect sizes make these of questionable clinical significance”. This
was based on 20 trials, of which 18 provided data suitable for pooling. The detailed
findings were as follows: “Topical antimicrobials increased absolute clinical cure
rates over placebo by 46% (95% confidence interval [CI], 29% to 63%) and
bacteriologic cure rates by 61% (95% CI, 46% to 76%). No significant differences
were noted in clinical cure rates for other comparisons, except that steroid alone
increased cure rates by 20% compared with steroid plus antibiotic (95% CI, 3% to
Gray ENT priorities draft 2 - 11 -
38%). Quinolone drops increased bacteriologic cure rates by 8% compared with
nonquinolone antibiotics (95% CI, 1% to 16%), but had statistically equivalent rates
of clinical cure and adverse events.

Bandolier noted a 2006 review on the role of antibiotics (RM Rosenfeld et al.
Systematic review of topical antimicrobial therapy for acute otitis externa.
Otolaryngology – Head and Neck Surgery 2006 134:S24-S48), concluding that “we
have a paucity of data to guide therapy for a relatively common condition”.
13


A protocol for a Cochrane review has been registered, with the following intentions:
“[t]o determine the effectiveness of different methods of managing acute diffuse otitis
externa. Methods of management to be considered include topical antibiotics, topical
astringents, topical alcohol, topical antiseptics, topical steroids, combination topical
treatments, systemic antibiotics, and aural toilet”.
14

4.5 Otitis media (acute and chronic)

The drug therapy mentioned in South African STG/EDL for acute otitis media (AOM)
is amoxicillin, oral, 30 mg/kg/dose 8 hourly for 5–10 days. For chronic, suppurative
otitis media, the recommended antimicrobial treatment is a fluoroquinolone eardrop
(such as ofloxacin drops, 2 drops 8 hourly instilled in the affected ear after dry
mopping for 4 weeks).

The Royal Children’s Hospital flowchart is as shown overleaf.
15
It offers co-
amoxiclav as a second-line choice antimicrobial. No specific analgesic is preferred.
However, a link is provided to an analgesia flowchart at
http://www.rch.org.au/clinicalguide/cpg.cfm?doc_id=5144. The RCH guideline
makes some important points: “Most cases of AOM in children resolve
spontaneously. Antibiotics provide a small reduction in pain beyond 24 hours in only
about 5% of children treated. The modest benefit must be weighed against the
potential harms related to antibiotic use, both for the individual patient (adverse
effects) and at a population level (resistance pressure). It has been shown that not
using antibiotics for otitis media is acceptable to parents if the reasons are explained
clearly. Pain is often the main symptom, so adequate analgesia is very important.
Paracetamol 20-30 mg/kg for 2-3 doses/day should be given if pain is significant.
Short-term use of topical 1% lignocaine drops applied to the tympanic membrane
seems anecdotally to be very effective for severe acute ear pain. Decongestants,
antihistamines and corticosteroids have not been shown to be effective in AOM.” No
evidence for the use of topical anaesthetic drops is provided.


Gray ENT priorities draft 2 - 12 -

RCH flowchart - http://www.rch.org.au/clinicalguide/cpg.cfm?doc_id=5284

The AHRQ site provides access to Evidence Report/Technology Assessment No 15
“Management of Acute Otitis Media”.
16
Medicine selection-related findings were as
follows:
• “Meta-analysis demonstrated a reduction in the clinical failure rate within 2 to
7 days of 12.3 percent (95 percent confidence intervals, 2.8 percent and 21.8
percent) in favor of ampicillin or amoxicillin therapy compared with placebo
or observational treatment. This result was generally robust to sensitivity
analysis. Eight children with AOM would need to be treated with ampicillin or
amoxicillin rather than no antibiotic treatment to avoid a case of clinical
failure.”
Gray ENT priorities draft 2 - 13 -
•
“Previous meta-analyses have demonstrated minimal to modest benefits of
antibiotics compared with observational intervention without antibiotics
during the initial treatment of AOM for the following outcomes: pain and
fever resolution at 2 days, pain resolution at 2 to 7 days, contralateral otitis
media and 7- to14-day clinical resolution rate. The following outcomes did not
appear to be affected by antibiotic use: pain resolution at 24 hours, pain and
fever resolution at 4 to 7 days, tympanic membrane perforation,
vomiting/diarrhea/rash, 1-month tympanometry, or recurrent AOM.”
•
“Meta-analyses did not demonstrate a significant rate difference in clinical
failure rates in children with AOM treated with ampicillin or amoxicillin
compared with children treated with penicillin, cefaclor, or cefixime.”
•
“Meta-analysis did not demonstrate a significant difference in clinical failure
rates in children treated with trimethoprim-sulfamethoxazole compared with
children treated with cefaclor for AOM.”
•
“Meta-analysis demonstrated that children treated with cefixime had an 8.4
percent greater rate of diarrhea than children treated with ampicillin or
amoxicillin. Twelve children with AOM would need to be treated with
ampicillin or amoxicillin rather than cefixime to avoid a case of diarrhea.”
A 2003 AHRQ report focused only on the late effects of OME, not on treatment or
management.
17


The Scottish Intercollegiate Guidelines network published guidelines for otitis media
in 2003.
18
While supporting a standard dose, 5-day course of antibiotics where
needed, it provided this level “A” statement on other medication: “Children with otitis
media should not be prescribed decongestants or antihistamines”. Similar advice
(including mucolytics and both topical and systemic steroids) was offered for otitis
media with effusion.

Both acute otitis media and otitis media with effusion have been the subject of
guidelines published by the American Academy of Pediatrics.
19,20
The initial choice of
antimicrobial, when used, is amoxicillin 80-90mg/kg/day. In relation to otitis media
with effusion (OME), the AAP offered the following guidance:
• “Watchful waiting: clinicians should manage the child with OME who is not
at risk with watchful waiting for 3 months from the date of effusion onset (if
known) or diagnosis (if onset is unknown)”
• “Medication: antihistamines and decongestants are ineffective for OME and
are not recommended for treatment; antimicrobials and corticosteroids do not
have long-term efficacy and are not recommended for routine management”

In the case of the latter advice, it was stated that “This recommendation is based on
systematic review of randomized, controlled trials and the preponderance of harm
over benefit.”

A review of the Canadian Paediatric Society guidelines (currently at
http://www.cps.ca/english/statements/ID/id97-03.htm) is underway. The 1998
guideline stated that “because of its excellent ‘track record’ (for infections due to
penicillin-susceptible and -resistant bacteria), low cost, safety and acceptability to
patients, amoxicillin remains the drug of choice for uncomplicated AOM.” It also
states that “In patients with documented allergy to penicillin, an alternative to
Gray ENT priorities draft 2 - 14 -
amoxicillin is required. Although there is a risk of cross-reaction to other beta-lactam
agents, this occurs rarely and therapy with a cephalosporin is generally safe. … The
choice should be guided by various considerations including cost, frequency of
adverse side-effects and patient tolerability. A reasonable choice is either
trimethoprim/sulfamethoxazole or erythromycin/sulfisoxazole.”

The choice of antimicrobial for otitis media is, of course, affected by local resistance
patterns. A 2005 review of the evidence suggested the following potential choices:
• “When antibiotic therapy is considered necessary, according to these
guidelines, amoxicillin (high-dose in most cases) represents the first-line
treatment for AOM.”
• “In patients who present with a severe illness (moderate to severe otalgia or
fever >=39C) therapy may also be initiated with high-dose Amoxicillin
clavulanate (Augmentin) in 2 divided doses for 10 days.”
• “If the patient is allergic to penicillin and the allergic reaction was not a
associated with urticaria or anaphylaxis (Type I), cefdinir (14 mg/kg/day in 1
or 2 doses), cefpodoxime (10 mg/kg/day once daily), or cefuroxime (30
mg/kg/day bid) can be used. In cases of Type I hypersensitivity reactions,
azithromycin (10 mg/kg/day on day 1, followed by 5 mg/kg/day for 4 days as
a single daily dose) or clarithromycin (15 mg/kg/day bid) can be used.”
• “In a patient who is vomiting or cannot otherwise tolerate oral medication, a
single dose of parental ceftriaxone (50 mg/kg) may be used for the treatment
of AOM.”
• “Patients who failed to improve after a 48—72 h initial management with
antibiotic agents should be treated with ceftriaxone (50 mg/kg/day for 3 days)
or high dose augmentin. A diagnostic tympanocentesis should be performed in
order to identify the etiologic organisms responsible for the failure of the first-
line therapy and their susceptibility to antibiotics.”
• “Alternative therapy in penicillin allergic is clindamycin (30—40 mg/kg/day)
in three divided doses.”
21


Although not guidelines per se, a number of Cochrane Reviews on the subject of otitis
media have been published.

The need for antibiotics in the management of acute otitis media in children was the
subject of a meta-analysis, based on 8 trials (including 2 287 children).
22
Notably, all
the trials included were conducted in developed countries. The findings were as
follows: “The trials showed no reduction in pain at 24 hours, but a 30% relative
reduction (95% confidence interval 19% to 40%) in pain at two to seven days. Since
approximately 80% of patients will have settled spontaneously in this time, this means
an absolute reduction of 7% or that about 15 children must be treated with antibiotics
to prevent one child having some pain after two days. There was no effect of
antibiotics on hearing problems of acute otitis media, as measured by subsequent
tympanometry. However, audiometry was done in only two studies and incompletely
reported. Nor did antibiotics influence other complications or recurrence. There were
few serious complications seen in these trials: only one case of mastoiditis occurred in
a penicillin treated group.” The authors’ conclusions – that “[a]ntibiotics provide a
small benefit for acute otitis media in children” and that “[a]s most cases will resolve
spontaneously, this benefit must be weighed against the possible adverse reactions”
was, however, balanced by this statement: “Antibiotic treatment may play an