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

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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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[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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Anonymous
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Anonymous
Solid work, thanks.

Anonymous
Goes above and beyond expectations !

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