Effectiveness of Analgesic Ear Drops as add-on Treatment to Oral Analgesics in Children With Acute Otitis Media: a Pragmatic Randomised Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- UMC Utrecht
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- The parent-reported ear pain score over the first three days
研究概览
简要总结
This trial aims to investigate whether analgesic ear drops added to usual care provide superior ear pain relief over usual care alone in children presenting to primary care with AOM. Children will be randomly allocated (ratio 1:1) to either 1) lidocaine hydrochloride 5mg/g ear drops (Otalgan) 1-2 drops up to six times daily for a maximum of 7 days in addition to usual care (oral analgesics, with/without antibiotics) or 2) usual care. Parents will complete a symptom diary for 4 weeks as well as generic and disease-specific quality of life questionnaires at baseline and 4 weeks. The primary outcome is the parent-reported ear pain score (0-10) over the first 3 days.
NOTE:
At the time of publication of the study protocol paper, the investigators were unable to make any amendments to the trial registration record in the Netherlands Trial Register (NTR) (NL9500; date of registration: 28 May 2021). The addition of a data sharing plan was required to adhere to the International Committee of Medical Journal Editors (ICMJE) guidelines. The investigators therefore re-registered the trial in ClinicalTrials.gov. This second registration is for modification purposes only and the NTR record (NL9500) should be regarded as the primary trial registration.
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
- None
入排标准
- 年龄范围
- 1 Year 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
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, etc)
- •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
研究组 & 干预措施
Lidocaine ear drops with usual care
usual care: oral analgesic with/without antibiotics
干预措施: lidocaine hydrochloride 5mg/g (Drug)
结局指标
主要结局
The parent-reported ear pain score over the first three days
时间窗: 3 days
Parents will record their child's ear pain scores during the first three consecutive days using a 0-10 validated numerical rating scale. Higher scores indicate greater severity.
次要结局
- number of participants with adverse events(during follow-up (4 weeks))
- proportion of children consuming antibiotics(in the first 7 days)
- overall symptom burden (crying/distress, disturbed sleep, interference with normal activity, appetite, fever and hearing problems) using a 0-6 Likert scale(in the first 7 days)
- number of days with ear pain(during follow up (4 weeks))
- proportion of children with oral analgesic use(in the first 7 days)
- number of GP reconsultations with/without subsequent antibiotic prescribing(during follow-up (4 weeks))
- number of participants with complications of AOM(during follow-up (4 weeks))
- costs(during follow-up (4 weeks))
- incremental cost-effectiveness ratios; calculated by dividing the estimated differences in costs between groups by the differences in effects observed(during follow-up (4 weeks))
- generic quality of life of the child assessed using the 47-item short-form of the Infant Toddler Quality of Life Questionnaire (ITQOL-SF47)(at baseline and at 4 weeks)
- disease-specific quality of life of the child assessed using the Otitis media-6 (OM-6) questionnaire(at baseline and at 4 weeks)
研究者
Roderick P. Venekamp
Associate Professor
UMC Utrecht