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

Sponsor

Lumbini Medical College (Other)

Overall Status

Completed

CT.gov ID

NCT03590912

Collaborator

(none)

160

Enrollment

Location

Arms

18.4

Actual Duration (Months)

8.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Otitis Media With Effusion	Drug: Mometasone 50 Mcg/Inh Nasal Spray Drug: Antibiotics + Antihistamine (levocetirizine) + Nasal decongestants (Oxymetazoline 0.025%) Drug: Steroid Drug (prednisolone)	Phase 4

Detailed Description

Treatment groups would be:

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

Study Design

Study Type:

Interventional

Actual Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Sep 5, 2018

Actual Primary Completion Date :

Feb 16, 2020

Actual Study Completion Date :

Mar 18, 2020

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Wait and watch (Group D) Wait and watch for 1 month
Experimental: Mometasone spray (Group B) Standard dose of mometasone furoate nasal spray (one spray in each nostril once daily) for one month will be given	Drug: Mometasone 50 Mcg/Inh Nasal Spray One spray in each nostril once daily for one month Other Names: Metaspray nasal spray
Experimental: 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	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 Other Names: Syp Cefpodoxime, Syrup levocetirizine 2.5mg/ml; Nasivion drop
Experimental: 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	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.