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

Phase 4

Completed

• Conditions: Otitis Media With Effusion
• Interventions: Drug: Mometasone 50 Mcg/Inh Nasal Spray; Drug: Antibiotics + Antihistamine (levocetirizine) + Nasal decongestants (Oxymetazoline 0.025%); Drug: Steroid Drug (prednisolone)

• Registration Number: NCT03590912
• Lead Sponsor: Lumbini Medical College

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

Study Timeline

• Study First Submitted: 2018-07-08
• Study First Submitted QC: 2018-07-08
• Study First Posted: 2018-07-18
• Study Start: 2018-09-05
• Primary Completion: 2020-02-16
• Study Completion: 2020-03-18
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-17
• Last Update Posted: 2020-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mometasone spray (Group B)	Mometasone 50 Mcg/Inh Nasal Spray	Standard dose of mometasone furoate nasal spray (one spray in each nostril once daily) for one month will be given
antibiotic + histaminic + oxymetazoline drops (Group A)	Antibiotics + Antihistamine (levocetirizine) + Nasal decongestants (Oxymetazoline 0.025%)	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
Oral steroid (Group C)	Steroid Drug (prednisolone)	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

Primary Outcome Measures

Name	Time	Method
Non B type tympanogram	one month

Secondary Outcome Measures

Name	Time	Method
Adverse effects	one month
cost of treatment	one month

Trial Locations

Locations (1)

Lumbini Medical College; 🇳🇵 Tansen, Palpa, Nepal