Therapeutics Randomised controlled trial
Topical antibiotic therapy is superior to systemic antibiotics for acute tympanostomy tube otorrhoea, but may not be necessary for all children 10.1136/eb-2014-101814
Richard M Rosenfeld Department of Otolaryngology, SUNY Downstate Medical Center, Brooklyn, New York, USA Correspondence to: Dr Richard M Rosenfeld, Department of Otolaryngology, SUNY Downstate Medical Center, 450 Clarkson Avenue, MSC 126, Brooklyn, NY 11203, USA; [email protected]
Commentary on: van Dongen TMA, van der Heijden GJMG, Venekamp RP, et al. A trial of treatment for acute otorrhea in children with tympanostomy tubes. N Engl J Med 2014;370:723–33.
Context Tympanostomy tube insertion is the most common ambulatory surgery performed on children.1 Discharge from the ear canal (otorrhoea) is the most common sequela of tubes, with a mean incidence of 26% in observational studies and up to 83% with prospective surveillance.2 3 Acute tympanostomy tube otorrhoea (TTO) is usually a manifestation of acute otitis media and may occur during a viral upper respiratory infection or when water penetrates the tube and enters the middle ear space.
Methods This open-label, pragmatic trial included 230 Dutch children aged 1–10 years with acute TTO (lasting up to 7 days) who were assigned randomly to three groups: (1) topical antibiotic eardrops (bacitracin, colistin and hydrocortisone) thrice daily for 7 days, (2) oral antibiotic (amoxicillin–clavulanate suspension) thrice daily for 7 days and (3) initial observation for 2 weeks. The ear canal was not cleaned at baseline and parents were not instructed to ‘pump’ the tragus after administering drops. Children were excluded if they had temperature above 38.5°C, had received antibiotics in the prior 2 weeks, had tubes inserted less than 2 weeks prior, had TTO in the past 4 weeks, had recurrent TTO episodes, Down syndrome, craniofacial anomalies or immunodeficiency.
the disease-specific scores showed small differences in some domains (emotional distress, caregiver concerns and hearing loss) that favoured eardrops. There were no differences seen among groups for change in physical distress scores on the Otitis Media-6 survey (completed by parents to measure disease-specific QoL) when assessed at 2 weeks. Treatment-related adverse events were mild and no complications of otitis media occurred.
Commentary While applying these results to practice, clinicians should ask themselves two questions: first, can the child be managed symptomatically (without antibiotics) and second, if active treatment is needed, what strategy is best? The second question is easier to answer, since topical antibiotic drops are most effective and systemic antibiotics, with their attendant adverse events, should be limited to cases where drops cannot penetrate the ear canal (because of oedema or debris that cannot be cleared), where there is cellulitis extending beyond the ear canal, or where a concurrent illness would benefit from antibiotic therapy (eg, streptococcal pharyngitis or acute bacterial sinusitis). The first question—can the child be managed symptomatically—is best answered by recalling that acute TTO is often the painless ‘runny ear’ equivalent of the ‘runny nose’ that accompanies viral upper respiratory infections. For this reason QoL was good at baseline in this trial and no change was seen in general QoL or in disease-specific physical distress scores after therapy. Although there were large differences in otorrhoea prevalence at 2 weeks, the implications of this otoscopic finding for children who are otherwise asymptomatic and have good QoL is unclear. This suggests a role for observation and aural toilet (eg, cleaning otorrhoea from the ear canal with a nasal aspirator) in children with minimal symptoms and good QoL. Any discharge that adheres to the ear canal opening or adjacent skin can be gently cleaned with a cotton-tipped applicator and hydrogen peroxide solution. Caregivers should also be advised to use water precautions during episodes of acute TTO, since moisture entering the ear canal could delay resolution. An important part of managing acute TTO in children is educating caregivers in advance regarding its significance and management, which can be readily accomplished using education sheets included in a clinical practice guideline on tympanostomy tubes from the American Academy of Otolaryngology—Head and Neck Surgery Foundation.1 Parents who use antibiotic ear drops should also be instructed to ‘pump’ the tragus after placing drops in the ear canal to promote penetration into the middle ear, which was apparently not performed in the current study. Competing interests None.
Findings Treatment success at 2 weeks (absence of otorrhoea by otoscopy) was observed in 95% of children after eardrops, 56% after oral antibiotics and 45% after observation, with a median duration of otorrhoea in the three groups of 4, 5 and 12 days, respectively. The risk difference for eardrops versus antibiotics was 39% (95% CI 26% to 51%) and for eardrops versus observation was 49% (95% CI 37% to 62%). At baseline the generic and disease-specific quality of life (QoL) scores indicated good QoL despite the otorrhoea, with comparable scores in all groups. After 2 weeks there were no differences in generic QoL scores among the study groups, while
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References 1. Rosenfeld RM, Schwartz SR, Pynnonen MA, et al. Clinical practice guideline: tympanostomy tubes in children. Otolaryngol Head Neck Surg 2013;149:S1–35. 2. Kay D, Nelson M, Rosenfeld RM. Meta-analysis of tympanostomy tube sequelae. Otolaryngol Head Neck Surg 2001;124:374–80. 3. Ah-Tye C, Paradise JL, Colborn DK. Otorrhea in young children after tympanostomy-tube placement for persistent middle-ear effusion: prevalence, incidence, and duration. Pediatrics 2001;107:1251–8.
Topical antibiotic therapy is superior to systemic antibiotics for acute tympanostomy tube otorrhoea, but may not be necessary for all children 10.1136/eb-2014-101814
Richard M Rosenfeld Department of Otolaryngology, SUNY Downstate Medical Center, Brooklyn, New York, USA Correspondence to: Dr Richard M Rosenfeld, Department of Otolaryngology, SUNY Downstate Medical Center, 450 Clarkson Avenue, MSC 126, Brooklyn, NY 11203, USA; [email protected]
Commentary on: van Dongen TMA, van der Heijden GJMG, Venekamp RP, et al. A trial of treatment for acute otorrhea in children with tympanostomy tubes. N Engl J Med 2014;370:723–33.
Context Tympanostomy tube insertion is the most common ambulatory surgery performed on children.1 Discharge from the ear canal (otorrhoea) is the most common sequela of tubes, with a mean incidence of 26% in observational studies and up to 83% with prospective surveillance.2 3 Acute tympanostomy tube otorrhoea (TTO) is usually a manifestation of acute otitis media and may occur during a viral upper respiratory infection or when water penetrates the tube and enters the middle ear space.
Methods This open-label, pragmatic trial included 230 Dutch children aged 1–10 years with acute TTO (lasting up to 7 days) who were assigned randomly to three groups: (1) topical antibiotic eardrops (bacitracin, colistin and hydrocortisone) thrice daily for 7 days, (2) oral antibiotic (amoxicillin–clavulanate suspension) thrice daily for 7 days and (3) initial observation for 2 weeks. The ear canal was not cleaned at baseline and parents were not instructed to ‘pump’ the tragus after administering drops. Children were excluded if they had temperature above 38.5°C, had received antibiotics in the prior 2 weeks, had tubes inserted less than 2 weeks prior, had TTO in the past 4 weeks, had recurrent TTO episodes, Down syndrome, craniofacial anomalies or immunodeficiency.
the disease-specific scores showed small differences in some domains (emotional distress, caregiver concerns and hearing loss) that favoured eardrops. There were no differences seen among groups for change in physical distress scores on the Otitis Media-6 survey (completed by parents to measure disease-specific QoL) when assessed at 2 weeks. Treatment-related adverse events were mild and no complications of otitis media occurred.
Commentary While applying these results to practice, clinicians should ask themselves two questions: first, can the child be managed symptomatically (without antibiotics) and second, if active treatment is needed, what strategy is best? The second question is easier to answer, since topical antibiotic drops are most effective and systemic antibiotics, with their attendant adverse events, should be limited to cases where drops cannot penetrate the ear canal (because of oedema or debris that cannot be cleared), where there is cellulitis extending beyond the ear canal, or where a concurrent illness would benefit from antibiotic therapy (eg, streptococcal pharyngitis or acute bacterial sinusitis). The first question—can the child be managed symptomatically—is best answered by recalling that acute TTO is often the painless ‘runny ear’ equivalent of the ‘runny nose’ that accompanies viral upper respiratory infections. For this reason QoL was good at baseline in this trial and no change was seen in general QoL or in disease-specific physical distress scores after therapy. Although there were large differences in otorrhoea prevalence at 2 weeks, the implications of this otoscopic finding for children who are otherwise asymptomatic and have good QoL is unclear. This suggests a role for observation and aural toilet (eg, cleaning otorrhoea from the ear canal with a nasal aspirator) in children with minimal symptoms and good QoL. Any discharge that adheres to the ear canal opening or adjacent skin can be gently cleaned with a cotton-tipped applicator and hydrogen peroxide solution. Caregivers should also be advised to use water precautions during episodes of acute TTO, since moisture entering the ear canal could delay resolution. An important part of managing acute TTO in children is educating caregivers in advance regarding its significance and management, which can be readily accomplished using education sheets included in a clinical practice guideline on tympanostomy tubes from the American Academy of Otolaryngology—Head and Neck Surgery Foundation.1 Parents who use antibiotic ear drops should also be instructed to ‘pump’ the tragus after placing drops in the ear canal to promote penetration into the middle ear, which was apparently not performed in the current study. Competing interests None.
Findings Treatment success at 2 weeks (absence of otorrhoea by otoscopy) was observed in 95% of children after eardrops, 56% after oral antibiotics and 45% after observation, with a median duration of otorrhoea in the three groups of 4, 5 and 12 days, respectively. The risk difference for eardrops versus antibiotics was 39% (95% CI 26% to 51%) and for eardrops versus observation was 49% (95% CI 37% to 62%). At baseline the generic and disease-specific quality of life (QoL) scores indicated good QoL despite the otorrhoea, with comparable scores in all groups. After 2 weeks there were no differences in generic QoL scores among the study groups, while
132
Evid Based Med August 2014 | volume 19 | number 4 |
References 1. Rosenfeld RM, Schwartz SR, Pynnonen MA, et al. Clinical practice guideline: tympanostomy tubes in children. Otolaryngol Head Neck Surg 2013;149:S1–35. 2. Kay D, Nelson M, Rosenfeld RM. Meta-analysis of tympanostomy tube sequelae. Otolaryngol Head Neck Surg 2001;124:374–80. 3. Ah-Tye C, Paradise JL, Colborn DK. Otorrhea in young children after tympanostomy-tube placement for persistent middle-ear effusion: prevalence, incidence, and duration. Pediatrics 2001;107:1251–8.
