TREATMENT OF ACUTE OTITIS

MEDIA IN CHILDREN UNDER 2

YEARS OF AGE
BY ALEJANDRO HOBERMAN, M.D., JACK L. PARADISE, M.D.,
HOWARD E. ROCKETTE, PH.D., NADER SHAIKH, M.D., M.P.H.,
ELLEN R. WALD, M.D., DIANA H. KEARNEY, R.N., C.C.R.C.,
D. KATHLEEN COLBORN, B.S., MARCIA KURS-LASKY, M.S.,
SONIKA BHATNAGAR, M.D., M.P.H., MARY ANN HARALAM,
C.R.N.P., LISA M. ZOFFEL, C.R.N.P., CARLY JENKINS, R.N.,
MARCIA A. POPE, R.N., TRACY L. BALENTINE, R.N., AND
KAREN A. BARBADORA, M.T

DOVIE YULLIA PUTRI

711 208 1463

PEMBIMBING :
dr. FAUZIAH HENNY, Sp.THT-KL

SMF ILMU THT-KL

RSU dr. PIRNGADI
MEDAN
ANATOMY OF EAR
OUTER EAR
MIDDLE EAR
INNER EAR
PHYSIOLOGY OF HEARING
 STAGE OF TYMPANIC MEMBRANE

Stage of
Stage of Stage of Stage of Stage of
Tuba
Hiperemis Supuratif Perforasi Resolusi
Occlusion
DIFFERENCE IN THE ANGLE OF THE
EUSTACHIAN TUBE IN THE INFANT AND THE
ADULT
ABSTRACT

Recommendations of antimicrobial treatment of children

Background
under 2 years of age with acute otitis media

Randomly involving 291 children aged 6 to 23 months, with

Methodes acute otitis media, to measure symptomatic responses and
rates of clinical failure against certain drugs

Children who received amoxicillin-clavulanate had better

Result symptom improvement and clinical failure and were lower
than those receiving placebo

Among children aged 6 to 23 months with acute otitis media,

Conclution treatment with amoxicillin-clavulanate for 10 days tends to
overcome symptoms and reduce the signs of acute infection
 INTRODUCTION

Acute otitis media is the most frequently diagnosed illness in children in the
United States and the most commonly cited indication for antimicrobial therapy in
children.

Amoxicillin–clavulanate has been shown to be the most effective treatment for

acute otitis media.

These clinical trials are conducted to determine the extent to which antimicrobial
treatment affects the course of symptoms and signs of acute otitis media,
irrespective of the apparent severity of the disease, among children 6 to 23
months of age in whom the diagnosis of acute otitis media is quite certain
METHODES

Requirements to be sampled :
Eligibility and - Children were required to have received at least two doses
Enrollment of pneumococcal conjugate vaccine.
- To have acute otitis media.

Stratified children into several groups randomly to be given

Randomization
amoxicillin-clauvanat and placebo.

Assessment of - Structured interview with child's parent

Symptoms - Follow up visit
Otoscopic
Examination, - Findings on otoscopy and photo endoscopic photos of the
Overall tympanic membrane  diagnosis
Assessment, - We categorize children to enter on clinical success criteria
and or clinical failure based on symptom improvement.
Managemen

The Primary outcome :

Outcomes - The time to resolution of symptoms
- The symptom burden over time.

Statistical Estimated from 120 samples can be analyzed by comparing

Analysis time with symptom improvement
RESULT

Study
Population
(pict 1) Symptomatic
Response
(Pict 2)

Efficacy of Clinical
Treatment Failure
(table 2)

Complications and
Adverse Events
(table 3)
Pict 2
 DISCUSSION

The principal side effects of treatment both with amoxicillin–clavulanate and with
rescue antimicrobial agents were diarrhea and dermatitis in the diaper area, but
the side effects were usually not severe enough to result in discontinuation of the
offending drug.

Measure the burden of symptoms over time, using a combination of symptomatic

responses and middle ear findings to categorize the overall results either as clinical
success or clinical failure

Selection of symptom resolution as the main outcome, that symptoms often recur
after heal, by determining the resolution time in two ways : the time at which an
AOM-SOS score of 0 or 1 was first recorded and the time of the second of two
successive recordings of an AOM-SOS score of 0 or 1. We also measured the
symptom burden over t
These observations, together with the fact that among infants and young chil-
dren, acute otitis media may be entirely asymptomatic and the fact that symptoms
may not differentiate acute otitis media from other respi- ratory illnesses, suggest
that overall clinical response constitutes the more telling measure of outcome

Young children otitis media with effusion is often a forerunner of acute otitis
media, it is possible that the higher prevalence of persistent effusion among the
children in the placebo group than among children in the amoxicillin–clavulanate
group might have placed the children in the placebo group at greater risk for
recurrent infection.
 CONCLUSION

In conclusion, among children 6 to 23 months of age with acute otitis media,

treatment with amoxicillin–clavulanate is better than placebo

The highest rate of clinical failure in children who were initially worst affected