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

Primary Purpose

Otitis Media With Effusion

Status
Completed
Phase
Phase 4
Locations
Nepal
Study Type
Interventional
Intervention
Mometasone 50 Mcg/Inh Nasal Spray
Antibiotics + Antihistamine (levocetirizine) + Nasal decongestants (Oxymetazoline 0.025%)
Steroid Drug (prednisolone)
Sponsored by
Lumbini Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Otitis Media With Effusion

Eligibility Criteria

1 Year - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lumbini Medical College

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Wait and watch (Group D)

Mometasone spray (Group B)

antibiotic + histaminic + oxymetazoline drops (Group A)

Oral steroid (Group C)

Arm Description

Wait and watch for 1 month

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

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

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

Outcomes

Primary Outcome Measures

Non B type tympanogram

Secondary Outcome Measures

cost of treatment
Adverse effects

Full Information

First Posted
July 8, 2018
Last Updated
June 17, 2020
Sponsor
Lumbini Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT03590912
Brief Title
Efficacy and Cost Analysis of Steroids in Treatment of Otitis Media With Effusion
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
September 5, 2018 (Actual)
Primary Completion Date
February 16, 2020 (Actual)
Study Completion Date
March 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lumbini Medical College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
We intend to study the cost of treatment, efficacy and adverse effects for Otitis media with effusion.
Detailed Description
Treatment groups would be: Cefpodoxime + oxymetaxoline drops + levocetirizine Fluticasone intranasal spray Short term oral steroids Wait and watch

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media With Effusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wait and watch (Group D)
Arm Type
No Intervention
Arm Description
Wait and watch for 1 month
Arm Title
Mometasone spray (Group B)
Arm Type
Experimental
Arm Description
Standard dose of mometasone furoate nasal spray (one spray in each nostril once daily) for one month will be given
Arm Title
antibiotic + histaminic + oxymetazoline drops (Group A)
Arm Type
Experimental
Arm Description
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
Arm Title
Oral steroid (Group C)
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Mometasone 50 Mcg/Inh Nasal Spray
Other Intervention Name(s)
Metaspray nasal spray
Intervention Description
One spray in each nostril once daily for one month
Intervention Type
Drug
Intervention Name(s)
Antibiotics + Antihistamine (levocetirizine) + Nasal decongestants (Oxymetazoline 0.025%)
Other Intervention Name(s)
Syp Cefpodoxime, Syrup levocetirizine 2.5mg/ml; Nasivion drop
Intervention Description
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
Intervention Name(s)
Steroid Drug (prednisolone)
Intervention Description
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 Outcome Measure Information:
Title
Non B type tympanogram
Time Frame
one month
Secondary Outcome Measure Information:
Title
cost of treatment
Time Frame
one month
Title
Adverse effects
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Lumbini Medical College
City
Tansen
State/Province
Palpa
ZIP/Postal Code
32500
Country
Nepal

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
As soon as the article is published online. Life-long

Learn more about this trial

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

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