Efficacy and Cost Analysis of Steroids in Treatment of Otitis Media With Effusion

Study Overview
=================
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: Cefpodoxime + oxymetaxoline drops + levocetirizine Fluticasone intranasal spray Short term oral steroids Wait and watch

Official Title
-----------------
Efficacy and Cost Analysis of Steroids in Treatment of Otitis Media With Effusion (OME) Compared to That of Combination of Antibiotic, Antihistaminic, and Nasal Decongestant

Conditions
-----------------
Otitis Media With Effusion

Intervention / Treatment
-----------------
* Drug: Mometasone 50 Mcg/Inh Nasal Spray
* Drug: Antibiotics + Antihistamine (levocetirizine) + Nasal decongestants (Oxymetazoline 0.025%)
* Drug: Steroid Drug (prednisolone)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Wait and watch (Group D)<br>Wait and watch for 1 month | |
| Experimental: Mometasone spray (Group B)<br>Standard dose of mometasone furoate nasal spray (one spray in each nostril once daily) for one month will be given | Drug: Mometasone 50 Mcg/Inh Nasal Spray<br>* One spray in each nostril once daily for one month<br>* Other names: Metaspray nasal spray;|
| Experimental: antibiotic + histaminic + oxymetazoline drops (Group A)<br>This group will receive oral cefpodoxime (10 mg/kg/day in two divided dose for a week) plus oral histaminics and oxymetazoline drops. Standard dose of oral histaminics (levocetirizine, 1.25 mg for age below six years, 2.5 mg for older age) for a month plus oxymetazoline nasal drops (Nasivion 0.025%) for two weeks will be given | Drug: Antibiotics + Antihistamine (levocetirizine) + Nasal decongestants (Oxymetazoline 0.025%)<br>* 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<br>* Other names: Syp Cefpodoxime, Syrup levocetirizine 2.5mg/ml; Nasivion drop;|
| Experimental: Oral steroid (Group C)<br>Patients in this group will receive one mg/kg/day of oral prednisolone (Oral steroid) in two divided dose for a week followed by half mg/kg/day in two divided dose for next one week | Drug: Steroid Drug (prednisolone)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non B type tympanogram |  | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cost of treatment |  | one month | 
| Adverse effects |  | one month |