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Completed

NCT Number: NCT03590912

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

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

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Key information

Conditions

OTITIS MEDIA WITH EFFUSION Ear Diseases Otitis Otitis Media Otorhinolaryngologic Diseases

Age range

1 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Lumbini Medical College

Tānsen, Palpa, 32500, Nepal

About this study

Treatment groups would be:

  • Cefpodoxime + oxymetaxoline drops + levocetirizine
  • Fluticasone intranasal spray
  • Short term oral steroids
  • Wait and watch

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mometasone 50 Mcg/Inh Nasal Spray

Drug

One spray in each nostril once daily for one month

Other names: Metaspray nasal spray

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

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

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

Steroid Drug (prednisolone)

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.

Primary outcomes

  1. Non B type tympanogram

    Time frame: one month

Secondary outcomes

  1. cost of treatment

    Time frame: one month

  2. Adverse effects

    Time frame: one month

Sponsors and collaborators

Lead sponsor

Lumbini Medical College

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 18, 2018
Registry last updated
Jun 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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