Efficacy of Auralgan for treating ear pain in children with acute otitis media. Topical lignocaine for pain relief in acute otitis media: results of a double-blind placebo-controlled randomised trial. Efficacy of naturopathic extracts in the management of ear pain associated with acute otitis media. Naturopathic treatment for ear pain in children.
To determine the efficacy of Auralgan otic solution (combination product of antipyrine, benzocaine, and glycerin) compared with an olive oil placebo in the management of moderate to severe ear pain in children with acute otitis media (AOM).
                Children 5 years or older who presented with ear pain and eardrum findings indicative of AOM were randomly assigned to treatment with Auralgan or olive oil drops instilled into the external auditory canal(s) of the affected ear(s). All children were also treated with 15 mg/kg of acetaminophen in a single dose. Ear pain was assessed by means of 2 visual analog seales-a linear scale and a color scale-at study entry and 10, 20, and 30 minutes later (T0, T10, T20, and T30, respectively). Results of the measurements on the 2 scales were evaluated independently and were averaged to determine an ear pain score. A baseline ear pain score of at least 3 points was required for study entry. Four outcome measures regarding ear pain score at T10, T20, and T30 were used: (1) proportion of subjects who showed 50% reduction, (2) proportion of subjects who showed 25% reduction, (3) proportion of subjects who showed a 1 or more point reduction, and (4) mean score over time.
                Primary care center and emergency department of a children's hospital.
                Fifty-four children aged 5 to 19 years with ear pain and AOM.
                The Auralgan and placebo groups were comparable regarding age, sex, race, laterality of AOM, and T0 ear pain score. By each of the 4 measures used, the response to treatment consistently favored the Auralgan group, but only at T30 were any differences statistically significant.
                In children with AOM-associated ear pain who are treated with acetaminophen, topically applied Auralgan appears likely to provide additional relief in varying degree within 30 minutes. 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. To determine the efficacy and tolerance of Otikon Otic Solution (Healthy-On Ltd, Petach-Tikva, Israel), a naturopathic herbal extract (containing Allium sativum, Verbascum thapsus, Calendula flores, and Hypericum perforatum in olive oil), compared with Anaesthetic (Vitamed Pharmaceutical Ltd, Benyamina, Israel) ear drops (containing ametocaine and phenazone in glycerin) in the management of ear pain associated with acute otitis media (AOM).
                Children between the ages of 6 and 18 years who experienced ear pain (otalgia) and who were diagnosed with eardrum problems associated with AOM were randomly assigned to be treated with Otikon or Anaesthetic ear drops, which were instilled into the external canal(s) of the affected ear(s). Ear pain was assessed using 2 visual analog scales: a linear scale and a color scale. Pain assessment took place throughout the course of 3 days. The mean score of pain reduction was used to measure outcome.
                Primary pediatric community ambulatory centers.
                One hundred three children aged 6 to 18 years who were diagnosed with otalgia associated with AOM.
                Each of the 2 treatment groups were comparable on the basis of age, sex, laterality of AOM, and the effectiveness of ameliorating symptoms of otalgia. The 2 groups were also comparable to each other in the initial ear pain score and in the scores at each application of Otikon or Anaesthetic drops. There was a statistically significant improvement in ear pain score throughout the course of the study period (P =.007).
                Otikon, an ear drop formulation of naturopathic origin, is as effective as Anaesthetic ear drops and was proven appropriate for the management of AOM-associated ear pain. Otitis media is 1 of the most frequent diseases of early infancy and childhood and 1 of the most common reasons for children to visit a physician. In the past 2 decades, there has been a substantial increase in the diagnosis of otitis media worldwide. In the United States, 93% of all children have had at least 1 episode of acute otitis media (AOM) by 7 years of age. Otalgia is the hallmark of AOM. Most affected children either complain of earache or manifest behavior that the parents interpret as indicating ear pain. Treatment of the ear pain early in the course of AOM decreases both parental anxiety and the child's discomfort and accelerates the healing process. The objective of this study was to determine the efficacy and tolerability of naturopathic versus traditional treatment for the management of otalgia commonly associated with AOM in children.
                The study was designed as a double-blind trial in an outpatient community clinic. A total of 171 children who were aged 5 to 18 years and had otalgia and clinical findings associated with middle-ear infection were studied. The children were randomly assigned to receive treatment with Naturopathic Herbal Extract Ear Drops (NHED) or anesthetic ear drops, with or without amoxicillin. On enrollment, the children were assigned by computer-numbered randomization to receive NHED (contents: allium sativum, verbascum thapsus, calendula flores, hypericum perfoliatum, lavender, and vitamin E in olive oil) 5 drops 3 times daily, alone (group A) or together with a topical anesthetic (amethocaine and phenazone in glycerin) 5 drops 3 times daily (group B), or oral amoxicillin 80 mg/kg/d (maximum 500 mg/dose) divided into 3 doses with either NHED 5 drops 3 times daily (group C) or topical anesthetic 5 drops 3 times daily (group D). A double-blind design was used, and all ear drops were placed in identical bottles. Treatment was initiated by the nurse in all cases. A single physician (M.S.) evaluated and treated all of the patients included in the study and recorded all of the data. The presence or absence of ear pain was assessed over 3 days with a visual analog scale. Ear pain was assessed by a specially devised observational instrument based on previous reports. One side of the instrument consisted of a linear numbered scale, from 1 (no pain) to 10 (worst possible pain), and a corresponding color scale, ranging from blue to dark red. The reverse side contained a scale of 5 facial expressions, ranging from broad smile (no pain) to a sad and crying face (worst possible pain), and a corresponding color scale, ranging from blue to dark red.
                There were no significant between-group differences in patient age or gender, degree of fever, main symptoms, associated symptoms, and severity or laterality of acute otitis media. Each group had a statistically significant improvement in ear pain over the course of the 3 days. Patients who were given ear drops alone had a better response than patients who were given ear drops together with amoxicillin. Results were better in the NHED group than in the controls. Nevertheless, the findings indicated that the pain was mostly (80%) self-limited and could be explained simply by the time elapsed. The American Academy of Otolaryngology-Head and Neck Surgery guidelines recommend topical medications as the first line of treatment for ear pain in the absence of systemic infection or serious underlying disease. Because no evidence was found that systemic antibiotics alone improved treatment outcome, if antibiotics do not change the natural course of otitis media, then the main goal of treatment, as in the present study, should be to alleviate the ear pain. The alternative, naturopathic herbal extract medications, may offer many new possibilities in the management of ear pain associated with AOM. Primary care physicians should be aware that at least 10% of their patients may have tried 1 or more forms of alternative/complementary medicine before presenting for consultation. As it was widely reported in the medical literature, these herb, these herbal extracts have the potential to meet all of the requirements of appropriate medication that could be routinely used in the pediatric patient, namely in vitro bacteriostatic and bacteriocidal activity against common pathogens, immunostimulation ability, antioxidant activity, and anti-inflammatory effects. They are also well-absorbed with good penetration into the tissue surrounding the tympanic membrane. They have been found to enhance local immunologic activity. Finally, herbal extracts are well-tolerated (owing to their long elimination time), easy to administer, and less expensive than the new antibiotics. There are no documented side effects. On the basis of our findings that the group with the most significant treatment effects (NHED with topical anesthetic) explained only 7.3% of the total pain reduction, we propose that sometimes the general practitioner or pediatrician needs to give the human body a chance to repair itself. Nevertheless, if the physician believes that there is an indication for some treatment, especially if the parents are anxious, then a local treatment such as one used in our study might be adequate.
                This study suggests that in cases of ear pain caused by AOM in children in which active treatment, besides a simple 2- to 3-day waiting period, is needed, an herbal extract solution may be beneficial. Concomitant antibiotic treatment is apparently not contributory.
Evidence from five RCTs, only two of which addressed the most relevant question of primary effectiveness, provides limited evidence that ear drops are effective 30 minutes after administration in older children with AOM. Uncertainty exists as to the magnitude of this effect and more high-quality studies are needed.