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

Lumbini Medical College

Status and phase: Completed; Phase 4

Conditions: Otitis Media With Effusion

Treatments: Drug: Mometasone 50 Mcg/Inh Nasal Spray; Drug: Antibiotics + Antihistamine (levocetirizine) + Nasal decongestants (Oxymetazoline 0.025%); Drug: Steroid Drug (prednisolone)

Study type: Interventional

Funder types: Other

Identifiers

NCT03590912

143

Details and patient eligibility

About

We intend to study the cost of treatment, efficacy and adverse effects for Otitis media with effusion.

Full description

Treatment groups would be:

1. Cefpodoxime + oxymetaxoline drops + levocetirizine
2. Fluticasone intranasal spray
3. Short term oral steroids
4. Wait and watch

Enrollment: 160 patients

Sex: All

Ages: 1 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 4 patient groups

Wait and watch (Group D)

No Intervention group

Description:

Wait and watch for 1 month

Mometasone spray (Group B)

Experimental group

Description:

Standard dose of mometasone furoate nasal spray (one spray in each nostril once daily) for one month will be given

Treatment:

Drug: Mometasone 50 Mcg/Inh Nasal Spray

antibiotic + histaminic + oxymetazoline drops (Group A)

Experimental group

Description:

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

Treatment:

Drug: Antibiotics + Antihistamine (levocetirizine) + Nasal decongestants (Oxymetazoline 0.025%)

Oral steroid (Group C)

Experimental group

Description:

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

Treatment:

Drug: Steroid Drug (prednisolone)