Bolt Penny, Barnett Peter, Babl Franz E, Sharwood Lisa N
Emergency Department, Royal Children's Hospital, Murdoch Children's Research Institute and University of Melbourne, Melbourne, Australia.
Arch Dis Child. 2008 Jan;93(1):40-4. doi: 10.1136/adc.2006.110429.
Acute otitis media (AOM) is common in children, yet the optimal management of ear pain associated with AOM has not been well studied. We set out to determine the efficacy of topical aqueous 2% lignocaine eardrops compared with a placebo (saline) for pain relief of AOM in children.
Double-blind, randomised, placebo-controlled trial.
Tertiary children's hospital emergency department.
Children aged between 3 and 17 years with earache and AOM without evidence of perforation were eligible. Patients were randomised to receive either 2% lignocaine or saline eardrops (placebo).
Pain scores were measured before and after ear-drop administration. Patient and physician-interpreted pain scores were measured by using the Bieri faces pain scale and visual analogue scale at 10, 20 and 30 minutes. The primary outcome measure was reduction in patient-measured pain scores by 50% from the baseline. Secondary outcome measures were reduction in patient-measured pain scores by 25% or by at least two points. Telephone follow-up occurred after 1 day and 1 week. Analysis was by intention to treat.
63 children (31 were treated with lignocaine, 32 with placebo) aged 3 to 12 years were enrolled. The groups were demographically and clinically similar, with similar proportions having received analgesia in the preceding 4 hours. Children receiving lignocaine showed significantly lower patient-measured pain scores with a reduction by 50% from baseline at 10 minutes (RR 2.06, 95% CI 1.03-4.11, p = 0.03) and 30 minutes (RR 1.44, 95% CI 1.07-1.93, p = 0.009) but not at 20 minutes (RR 1.35 95% CI 0.88-2.06). The response to lignocaine treatment showed significantly lower patient-measured pain scores for 25% reduction at all time points and for two-point reduction at 10 minutes and favoured lignocaine at 20 minutes and 30 minutes without reaching statistical significance. There were no serious adverse events during the 30 minute follow-up period.
This study suggests that topical aqueous 2% lignocaine eardrops provide rapid relief for many young children presenting with ear pain attributed to AOM. The concurrent use of simple oral analgesia is a likely contributor to effective management of this painful childhood condition.
急性中耳炎（AOM）在儿童中很常见，但与AOM相关的耳痛的最佳治疗方法尚未得到充分研究。我们旨在确定与安慰剂（盐水）相比，局部使用2%利多卡因水性耳滴对缓解儿童AOM耳痛的疗效。
双盲、随机、安慰剂对照试验。
三级儿童医院急诊科。
年龄在3至17岁之间、有耳痛且AOM无穿孔迹象的儿童符合条件。患者被随机分配接受2%利多卡因或盐水耳滴（安慰剂）。
在滴耳前后测量疼痛评分。在10、20和30分钟时，使用比耶里面部疼痛量表和视觉模拟量表测量患者和医生解读的疼痛评分。主要观察指标是患者测量的疼痛评分从基线降低50%。次要观察指标是患者测量的疼痛评分降低25%或至少降低2分。在1天和1周后进行电话随访。分析采用意向性分析。
纳入了63名年龄在3至12岁之间的儿童（31名接受利多卡因治疗，32名接受安慰剂治疗）。两组在人口统计学和临床特征上相似，在前4小时内接受镇痛的比例相似。接受利多卡因治疗的儿童在10分钟（RR 2.06，95%CI 1.03 - 4.11，p = 0.03）和30分钟（RR 1.44，95%CI 1.07 - 1.93，p = 0.009）时患者测量的疼痛评分显著低于基线，降低了50%，但在20分钟时未降低（RR 1.35，95%CI 0.88 - 2.06）。利多卡因治疗的反应在所有时间点患者测量的疼痛评分降低25%以及在10分钟时降低至少2分方面均显著较低，在20分钟和30分钟时利多卡因更有优势，但未达到统计学意义。在30分钟的随访期内没有严重不良事件。
本研究表明，局部使用2%利多卡因水性耳滴可为许多因AOM出现耳痛的幼儿提供快速缓解。同时使用简单的口服镇痛药可能有助于有效治疗这种疼痛的儿童疾病。
