NL-OMON23221尚未招募不适用

Effectiveness of analgesic ear drops as add-on treatment to oral analgesics in children with acute otitis media: a pragmatic randomised controlled trial

Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht0 个研究点目标入组 300 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

暂无简介。

•- Children with (suspected) non-intact tympanic membrane (perforation or tubes) with/without otorrhoea, including children with ear wax which hampers accurate tympanic membrane assessment upon otoscopy.
•- Children 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).
•- Children who are at high risk of serious complications including children with known immunodeficiency other than partial IgA or IgG2 deficiencies, craniofacial malformation such as cleft palate, Down syndrome and previous ear surgery
•- Children who have a known allergy or sensitivity to study medicine or similar substances, e.g. other amide-type anesthetics (such as bupivacaine, mepivacaine and prilocaine)
•- Children 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.
•- Children who need to continue taking other medicinal products containing lidocaine
•- Children who have proven alternative source(s) of pain other than, and more severe than, the ear symptoms with which they are presenting.
•- Children who have already participated in this trial

发起方

Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht