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NCT03590912 Clinical Trial

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

Otitis Media With Effusion Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03590912
Other study ID # 143
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 5, 2018
Est. completion date March 18, 2020

Study information
Verified date June 2020
Source Lumbini Medical College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

Treatment groups would be:

1. Cefpodoxime + oxymetaxoline drops + levocetirizine

2. Fluticasone intranasal spray

3. Short term oral steroids

4. Wait and watch

Recruitment information / eligibility
Status Completed
Enrollment 160
Est. completion date March 18, 2020
Est. primary completion date February 16, 2020
Accepts healthy volunteers No
Gender All
Age group 1 Year to 12 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Mometasone 50 Mcg/Inh Nasal Spray
One spray in each nostril once daily for one month
• Antibiotics + 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
• Steroid 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.

Locations
Country Name City State
Nepal Lumbini Medical College Tansen Palpa

Sponsors (1)
Lead Sponsor Collaborator
Lumbini Medical College

Country where clinical trial is conducted

Nepal, 

Outcome
Type Measure Description Time frame Safety issue
Primary Non B type tympanogram one month
Secondary cost of treatment one month
Secondary Adverse effects one month
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