NL-OMON54000已完成3 期
Effectiveness of analgesic ear drops as add-on treatment to oral analgesics in children with acute otitis media: a pragmatic randomised controlled trial - analgesic ear drops for children with acute otitis media (OPTIMA)
niversitair Medisch Centrum Utrecht0 个研究点目标入组 300 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 11（—）
入选标准
- •- Age 1 to 6 years
- •- Parent-reported ear pain in 24 hours prior to enrolment
- •- GP-diagnosis of (uni- or bilateral) AOM
排除标准
- •- with (suspected) tympanic membrane perforation or ventilation tubes
- •- with ear wax obscuring visualisation of the tympanic membrane
- •- who are systemically very unwell or require hospital admission (e.g. child
- •has signs and symptoms of serious illness and/or complications such as
- •mastoiditis/meningitis).
- •- who are at high risk of serious complications including children with known
- •immunodeficiency other than partial IgA or IgG2 deficiencies, craniofacial
- •malformation including cleft palate, Down syndrome and previous ear surgery
- •(with the exception of ventilation tubes in the past).
- •- who have a known allergy or sensitivity to study medication or similar
- •substances (e.g. other amide-type anaesthetics, bupivacaine, mepivacaine,
- •prilocaine)
- •- who have taken part in any research involving medicines within the last 90
- •days, or any other AOM-related research within the last 30 days.
- •- who suffer from chronic recurrent pain of another origin than the ear.
- •- who have participated in this trial during prior AOM episode.
研究者
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