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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-05

Study Completion Date

2020-03-18

Brief Summary

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

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Detailed Description

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Treatment groups would be:

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

Conditions

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Otitis Media With Effusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Wait and watch (Group D)

Wait and watch for 1 month

Group Type NO_INTERVENTION

No interventions assigned to this group

Mometasone spray (Group B)

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

Group Type EXPERIMENTAL

Mometasone 50 Mcg/Inh Nasal Spray

Intervention Type DRUG

One spray in each nostril once daily for one month

antibiotic + histaminic + oxymetazoline drops (Group A)

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Oral steroid (Group C)

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

Group Type EXPERIMENTAL

Steroid Drug (prednisolone)

Intervention Type DRUG

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.

Interventions

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Mometasone 50 Mcg/Inh Nasal Spray

One spray in each nostril once daily for one month

Intervention Type DRUG

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

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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Metaspray nasal spray Syp Cefpodoxime, Syrup levocetirizine 2.5mg/ml; Nasivion drop

Eligibility Criteria

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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