Topical lignocaine for pain relief in acute otitis media: results of a double-blind placebo-controlled randomised trial

Abstract

Objective: 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. Design: Double-blind, randomised, placebo-controlled trial. Setting: Tertiary children's hospital emergency department. Patients and interventions: 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). Main outcome measures: 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. Results: 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. Conclusion: 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.

The Diagnosis and Management of Acute Otitis Media

“…Two (including Bolt et al, 65 discussed above) compared anesthetic drops and placebo at diagnosis of AOM. In both studies, some children also received oral analgesics.…”

“…The Cochrane group concluded that there is limited evidence that ear drops are effective at 30 minutes and unclear if results from these studies are a result of the natural course of illness, placebo effect of receiving treatment, soothing effect of any liquid in the ear, or the drops themselves. Three of the studies included in this review were cited in the 2004 AAP guideline [67][68][69] and the 1 new paper by Bolt et al 65 Key Action Statement 3A…”

“…Additional, but brief, benefit over acetaminophen in patients older than 5 y. Naturopathic agents 68 Comparable to amethocaine/phenazone drops in patients older than 6 y. Homeopathic agents 71,72 No controlled studies that directly address pain. Narcotic analgesia with codeine or analogs 65 They used a convenience sample of children 3 to 17 years of age diagnosed with AOM in the ED. They excluded children with perforation of the TM, pressure-equalizing tube, allergy to local anesthetic or paracetamol, epilepsy, or liver, renal, or cardiac disease.…”

Diagnostic and Therapeutic Algorithmfor Acute Otitis Media

“…Лидокаин обладает местноане-стезирующим действием, что обусловлено блокадой потенциал-зависимых Na+-каналов, что препятствует генерации импульсов в окончаниях чувствительных нервов. Дополнительный эффект Отипакса связывают с гидроскопической активностью глицерина, входящего в их состав [25]. Последний, вероятно, снижает давление экссудата на БП.…”

“…Эффективность топических анальгетиков в форме ушных капель продемонстрирована в некоторых рандо-мизированных плацебо-контролируемых исследовани-ях [25,26]. Препараты данной группы могут быть реко-мендованы в терапии острого среднего отита у детей старше 2 лет.…”