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

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

Sponsors

Lead Sponsor: Lumbini Medical College

Source 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

Overall Status Completed
Start Date 2018-09-05
Completion Date 2020-03-18
Primary Completion Date 2020-02-16
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Non B type tympanogram one month
Secondary Outcome
Measure Time Frame
cost of treatment one month
Adverse effects one month
Enrollment 160
Condition
Intervention

Intervention Type: Drug

Intervention Name: Mometasone 50 Mcg/Inh Nasal Spray

Description: One spray in each nostril once daily for one month

Arm Group Label: Mometasone spray (Group B)

Other Name: Metaspray nasal spray

Intervention Type: Drug

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

Description: 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

Arm Group Label: antibiotic + histaminic + oxymetazoline drops (Group A)

Other Name: Syp Cefpodoxime, Syrup levocetirizine 2.5mg/ml; Nasivion drop

Intervention Type: Drug

Intervention Name: Steroid Drug (prednisolone)

Description: 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.

Arm Group Label: Oral steroid (Group C)

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

Gender:

All

Minimum Age:

1 Year

Maximum Age:

12 Years

Healthy Volunteers:

No

Location
Facility: Lumbini Medical College
Location Countries

Nepal

Verification Date

2020-06-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Wait and watch (Group D)

Type: No Intervention

Description: Wait and watch for 1 month

Label: Mometasone spray (Group B)

Type: Experimental

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

Label: antibiotic + histaminic + oxymetazoline drops (Group A)

Type: Experimental

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

Label: Oral steroid (Group C)

Type: Experimental

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

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

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