Kara Ateş, Büyükcam Ayşe, Sütçü Murat, Sali Enes, Bozdemir Şefika Elmas, Kara Manolya, İlarslan Eda Çullas, Kaya Cemil, Karakaşlılar Sabahat, Sönmez Gülsüm, Kara Soner Sertan, Bedir Tuğba, Albayrak Eda, Kara Tuğçe Tural, Çelebi Solmaz, Öz Fatma Nur, Karbuz Adem, Somer Ayper, Alabaz Derya, Tezer Hasan, Özdemir Halil, Çiftçi Ergin
Hacettepe Medical University, Department of Pediatric Infectious Disease, Ankara, Turkey.
Konya Training Training and Research Hospital, Department of Pediatric Infectious Disease, Konya, Turkey.
Int J Pediatr Otorhinolaryngol. 2022 May;156:111116. doi: 10.1016/j.ijporl.2022.111116. Epub 2022 Mar 21.
Acute otitis media (AOM) is one of the most common childhood infections. Ear pain, the main symptom of AOM, results in parents frequently seeking medical assistance for their children. The aim of this study was to compare the effectiveness of topical 1% lidocaine ear drops administered with oral analgesics with that of oral analgesics alone.
This multicenter randomized, open-labeled study was conducted at 15 centers with 184 pediatric AOM patients with bilateral ear pain (aged 1-5 years) between May 1, 2016, and June 31, 2018. All patients received oral paracetamol or ibuprofen and topical 1% lidocaine, which was administered to each ear according to the randomization list. The ear pain score was evaluated within 48 h using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale, and the patients were followed up for 10 days.
The median age was 31.8 months (min-max, 12-84.2 months). Of those patients enrolled, 22.3% received paracetamol, and 24.5% received paracetamol with lidocaine ear drops; 23.4% received ibuprofen, and 29.9% received ibuprofen with lidocaine ear drops. Lower pain scores were significantly measured at baseline and 10th minutes by a reduction 25% (RR 13.64, 95% CI 4.47-41.63, p = 0.001, RR 0.14, 95% CI 0.06-0.35, p = 0.001) and 50% (RR 4.76, 95% CI 1.63-13.87, p = 0.004, RR 0.14, 95% CI 0.05-0.4, p = 0.001) in the paracetamol and lidocaine versus paracetamol groups and the ibuprofen and lidocaine versus ibuprofen groups, respectively. No serious side effects were evident during follow-up.
This randomized study suggests that topical 1% lidocaine ear drops with paracetamol or ibuprofen seems to provide effective and rapid relief for children presenting with ear pain attributed to AOM.
急性中耳炎（AOM）是儿童最常见的感染之一。耳痛作为AOM的主要症状，导致家长频繁为孩子寻求医疗帮助。本研究的目的是比较局部使用1%利多卡因耳滴剂联合口服镇痛药与单独使用口服镇痛药的效果。
本多中心随机、开放标签研究在15个中心进行，纳入了2016年5月1日至2018年6月31日期间184例双侧耳痛的儿科AOM患者（年龄1 - 5岁）。所有患者均接受口服对乙酰氨基酚或布洛芬以及局部1%利多卡因，根据随机列表分别滴入每只耳朵。使用面部、腿部、活动、哭闹和可安慰性（FLACC）量表在48小时内评估耳痛评分，并对患者进行10天的随访。
中位年龄为31.8个月（最小 - 最大，12 - 84.2个月）。在纳入的患者中，22.3%接受对乙酰氨基酚治疗，24.5%接受对乙酰氨基酚联合利多卡因耳滴剂治疗；23.4%接受布洛芬治疗，29.9%接受布洛芬联合利多卡因耳滴剂治疗。在基线和第10分钟时，对乙酰氨基酚联合利多卡因组与对乙酰氨基酚组相比，以及布洛芬联合利多卡因组与布洛芬组相比，疼痛评分显著降低，分别降低了25%（RR 13.64，95%CI 4.47 - 41.63，p = 0.001，RR 0.14，95%CI 0.06 - 0.35，p = 0.001）和50%（RR 4.76，95%CI 1.63 - 13.87，p = 0.004，RR 0.14，95%CI 0.05 - 0.4，p = 0.001）。随访期间未发现严重副作用。
这项随机研究表明，局部使用1%利多卡因耳滴剂联合对乙酰氨基酚或布洛芬似乎能为因AOM出现耳痛的儿童提供有效且快速的缓解。
