Trials / Completed
CompletedNCT03590912
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
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 160 (actual)
- Sponsor
- Lumbini Medical College · Academic / Other
- Sex
- All
- Age
- 1 Year – 12 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Mometasone 50 Mcg/Inh Nasal Spray | One spray in each nostril once daily for one month |
| 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 |
| 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. |
Timeline
- Start date
- 2018-09-05
- Primary completion
- 2020-02-16
- Completion
- 2020-03-18
- First posted
- 2018-07-18
- Last updated
- 2020-06-19
Locations
1 site across 1 country: Nepal
Source: ClinicalTrials.gov record NCT03590912. Inclusion in this directory is not an endorsement.