Otitis Media With Effusion
Conditions
Brief summary
We intend to study the cost of treatment, efficacy and adverse effects for Otitis media with effusion.
Detailed description
Treatment groups would be: 1. Cefpodoxime + oxymetaxoline drops + levocetirizine 2. Fluticasone intranasal spray 3. Short term oral steroids 4. Wait and watch
Interventions
DRUGMometasone 50 Mcg/Inh Nasal Spray
One spray in each nostril once daily for one month
DRUGAntibiotics + Antihistamine (levocetirizine) + Nasal decongestants (Oxymetazoline 0.025%)
Children in this group will be treated with antiboitics (syp cefpodoxime) at 10 mg/kg/day in two divided dose for a week, plus antihistamine and nasal decongestants. Oral levocetirizine (Syrup levocet 2.5 mg/5ml) 1.25 mg once daily for age up to six years, 2.5 mg once daily for elder children for a month, plus oxymetazoline (Nasivion) 0.025%, 4 drops twice daily for two weeks
DRUGSteroid Drug (prednisolone)
This group will be treated with steroid drugs. Oral prednisolone, 1 mg/kg body weight daily in two divided dose for 1 week followed by half mg/kg/day in two divided dose for next one week.
Sponsors
Lumbini Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* history of mild ear ache or decreased hearing for three or more months, plus * intact and immobile tympanic membrane by pneumatic otoscopy * Type B tympanogram
Exclusion criteria
* any external ear condition that hampers visualization of tympanic membrane * lost to follow up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Non B type tympanogram | one month |
Secondary
| Measure | Time frame |
|---|---|
| cost of treatment | one month |
| Adverse effects | one month |
Countries
Nepal
Outcome results
None listed