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
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Otitis
• Otitis Media
• Otitis Media with Effusion

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