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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Non B type tympanogram
研究概览
简要总结
We intend to study the cost of treatment, efficacy and adverse effects for Otitis media with effusion.
详细描述
Treatment groups would be:
- Cefpodoxime + oxymetaxoline drops + levocetirizine
- Fluticasone intranasal spray
- Short term oral steroids
- Wait and watch
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •any external ear condition that hampers visualization of tympanic membrane
- •lost to follow up
研究组 & 干预措施
Mometasone spray (Group B)
Standard dose of mometasone furoate nasal spray (one spray in each nostril once daily) for one month will be given
干预措施: Mometasone 50 Mcg/Inh Nasal Spray (Drug)
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
干预措施: Antibiotics + Antihistamine (levocetirizine) + Nasal decongestants (Oxymetazoline 0.025%) (Drug)
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
干预措施: Steroid Drug (prednisolone) (Drug)
结局指标
主要结局
Non B type tympanogram
时间窗: one month
次要结局
- cost of treatment(one month)
- Adverse effects(one month)