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

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

Study Overview

• Status: Completed
• Conditions: Otitis Media With Effusion
• Intervention / Treatment: Drug: Mometasone 50 Mcg/Inh Nasal Spray; Drug: Antibiotics + Antihistamine (levocetirizine) + Nasal decongestants (Oxymetazoline 0.025%); Drug: Steroid Drug (prednisolone)

Detailed Description

Treatment groups would be:

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

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 4

Contacts and Locations

Study Locations

• Nepal
  • Palpa
    • Tansen, Palpa, Nepal, 32500
      • Lumbini Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Non B type tympanogram	one month

Secondary Outcome Measures

Outcome Measure	Time Frame
cost of treatment	one month
Adverse effects	one month

Collaborators and Investigators

• Sponsor: Lumbini Medical College

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2018
• Primary Completion (Actual): February 16, 2020
• Study Completion (Actual): March 18, 2020

Study Registration Dates

• First Submitted: July 8, 2018
• First Submitted That Met QC Criteria: July 8, 2018
• First Posted (Actual): July 18, 2018

Study Record Updates

• Last Update Posted (Actual): June 19, 2020
• Last Update Submitted That Met QC Criteria: June 17, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Media; Otitis Media with Effusion; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protective Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Cardiotonic Agents; Dermatologic Agents; Respiratory System Agents; Anti-Allergic Agents; Histamine Agents; Sympathomimetics; Histamine H1 Antagonists, Non-Sedating; Vasoconstrictor Agents; Mydriatics; Adrenergic alpha-1 Receptor Agonists; Prednisolone; Anti-Bacterial Agents; Cetirizine; Mometasone Furoate; Levocetirizine; Phenylephrine; Oxymetazoline; Histamine H1 Antagonists; Histamine Antagonists; Cefpodoxime; Nasal Decongestants
• Other Study ID Numbers: 143

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: As soon as the article is published online. Life-long
• IPD Sharing Supporting Information Type: Statistical Analysis Plan (SAP); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No