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To determine the effect of antibiotic (Amoxicillin) vs placebo for the treatment of acute otitis med

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Health & Medical

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JUSTIFICATION FOR THE STUDY
AUTHOR:
The following study plan was held in between Feb-May (1996-1998) in the Netherlands
where the general practitioners treated patients with acute otitis media aged 6-24 months i.e.;
children who were under 2years. Acute otitis media is defined as a process in which the middle
ear shows the signs and symptoms of acute inflammation. It mainly presents with pain, malaise,
irritability, fever and vomiting.
OBJECTIVES:
To determine the effect of antibiotic (Amoxicillin) vs placebo for the treatment of acute
otitis media in children of age 6 months to 2 years.
Purpose and hypothesis:
Otitis media is the most common childhood infection for which antibiotics are prescribed.
Nonetheless, there are number of important questions about the optimal management of acute
otitis media. Surprisingly the efficacy of antibiotics is seen limited in terms of therapeutic effect
in some countries but however, currently antibiotics are the common regiment for acute otitis
media in nearly all the countries.
METHODOLOGY:
In this study plan 240 children aged 6 months to 2 years with the diagnosis of acute otitis
media were selected. Patients were given either amoxicillin suspension 40mg/kg/day or placebo
suspension for 10 days three times a day. Due to decongestion the patients were also given
decongestion nose drops three times a day for 7days in each nostril. The use of Panadol was also
allowed when the patients felt pain. After the permission the children were assigned to treatment
with amoxicillin suspension or placebo suspension both contained the same taste and color.
PRIMARY AND SECONDARY END POINTS:
The primary outcome at the day 4 included symptoms like earache, crying, fever (>38)
and irritation. While the secondary outcome measures at the day 11 included clinical treatment
failure, irritation, fever, redness, bulging, pain, crying, perforation of the tympanic membranes.
INCLUSION AND EXCLUSION CRITERIA:
Acute otitis media management should include pain evaluation and treatment.
Antibiotics should be prescribed for bilateral or unilateral acute otitis media in
children aged 6 months with severe signs and symptoms and for non-severe acute
otitis media in children aged 6-24 months.
The following exclusion criteria was applied on the study: antibiotic treatment in
the preceding four weeks proved allergy to amoxicillin, compromised immunity,

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cranio facial abnormalities, down syndrome and the 53 general practitioners were
asked to classify the ear drums.
RESULTS:
In this study more symptoms are seen in patients treated with amoxicillin than
placebo at day 4.
At day 6 no such significant difference was seen in symptoms and otoscopy.
The duration of fever was shortened due to amoxicillin by one day and analgesics
were given more in placebo cases.
The fact that more analgesics were used in the placebo group could explain the
lack of difference in duration of pain or crying.
Diagnoses were based on acute signs of infection and abnormality of the ear
drum; this has shown to be adequate in other studies3 4 and is in accord with day
to day practice in the Netherlands.
The treatment regimen we used (amoxicillin 40mg/kg/daily) is still the treatment
of first choice.
As primary outcome measure we combined earache, crying, and irritability
because in these little children it is difficult to establish earache as such. We have
shown that seven to eight children aged 6 to 24 months with acute otitis media
needed to be treated to improve symptomatic outcome at day four in one child.
This is not sufficiently important clinically to prescribe antibiotics for every
affected child within this age group. Routine prescription of antibiotics would not
prevent all cases of meningitis.
CONCLUSION:
Several conducting analysis have shown that the effectiveness of antibiotics for acute
otitis media is limited in terms of clinical improvement. For children under 2 years of age—a
risk group with regard to poor outcome—the evidence of the effectiveness of antibiotics for this
common condition is not conclusive.
This randomized study shows that seven to eight children, aged 6 to 24 months, with
acute otitis media need to be treated with amoxicillin to improve symptomatic outcome at day
four in one
Child. This is not sufficiently important clinically to prescribe antibiotics for every child
with acute otitis media in this age group. Watchful waiting at the first visit is therefore
Justified for these children.
REASON FOR DIFFERENT STRATEGIES:

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[Type the company name][Type the document title][Type the document subtitle]Acer[Pick the date] JUSTIFICATION FOR THE STUDYAUTHOR: The following study plan was held in between Feb-May (1996-1998) in the Netherlands where the general practitioners treated patients with acute otitis media aged 6-24 months i.e.; children who were under 2years. Acute otitis media is defined as a process in which the middle ear shows the signs and symptoms of acute inflammation. It mainly presents with pain, malaise, irritability, fever and vomiting.OBJECTIVES:To determine the effect of antibiotic (Amoxicillin) vs placebo for the treatment of acute otitis media in children of age 6 months to 2 years.Purpose and hypothesis: Otitis media is the most common childhood infection for which antibiotics are prescribed. Nonetheless, there are number of important questions about the optimal management of acute otitis media. Surprisingly the efficacy of antibiotics is seen limited in terms of therapeutic effect in some countries but however, currently antibiotics are the common regiment for acute otitis media in nearly all the countries. METHODOLOGY:In this study plan 240 children aged 6 months to 2 years with the diagnosis of acute otitis media were selected. Patients were given either amoxicillin suspension 40mg/kg/day or placebo suspension for 10 days three times a day. Due to decongestion the patients were also given decongestion nose drops ...
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